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25 pages, 1928 KB  
Article
Surgically Relative Risk Factors for Lower Colorectal Anastomotic Dehiscence and Rectovaginal Fistulas in Complex Deep Endometriosis Cases: A Single-Center Retrospective–Prospective Cohort Study
by Krzysztof Nowak, Alicja Dąbrowska, Maja Mrugała and Ewa Milnerowicz-Nabzdyk
J. Clin. Med. 2026, 15(7), 2630; https://doi.org/10.3390/jcm15072630 - 30 Mar 2026
Viewed by 542
Abstract
Background: Bowel surgery is a key component of advanced deep endometriosis management, with anastomotic leakage representing the most serious postoperative complication. This study aimed to identify risk factors for dehiscence after lower colorectal anastomosis and to determine effective preventive measures. Methods: [...] Read more.
Background: Bowel surgery is a key component of advanced deep endometriosis management, with anastomotic leakage representing the most serious postoperative complication. This study aimed to identify risk factors for dehiscence after lower colorectal anastomosis and to determine effective preventive measures. Methods: This retrospective/prospective study included 425 consecutive patients aged 37.7 ± 6.0 years with laparoscopical bowel resection due to multiorgan complex deep endometriosis. All bowel surgeries were performed with use of indocyanine green (ICG). Many technical aspects of surgery and preventive procedures were analyzed which could impact leakage risk of surgery. Results: Endometriotic nodules were resected with segmental bowel resection (n = 294; 69.8%), discoid bowel resection (n = 84; 20.0%), and shaving procedure (n = 43; 10.2%). A total of 12 dehiscence events occurred (2.8%), including intraperitoneal leakage (n = 1; 0.2%), rectovaginal fistula (RVF) (n = 10; 2.3%), and rectoureteral fistula (n = 1; 0.2%); no rectovesical fistulas were observed. RVF developed only following segmental resections. Protective measures used during lower bowel procedures included fibrin glue (n = 375; 88.2%), omental flaps (n = 86; 20.2%), reinforcing sutures (n = 33; 7.8%), protective stomas (n = 25; 5.9%), and ghost stomas (n = 14; 3.3%). Among patients who developed RVFs, 90% had no protective stoma, and these cases were predominantly associated with low (from 6 to <8 cm; n = 4/77; 5.2%) and very low (from 5 to <6 cm; n = 4/10; 40%) anastomoses. In very low anastomoses (n = 4), 1 RVF occurred despite a protective stoma but there existed other strong risk factors, such as levator ani infiltration and vagina opening, whereas 3 others RVF developed in patients without a protective stoma. Notably, in ultra-low anastomoses (<5 cm), protective stomas prevented the anastomosis in 100%, and no fistula was observed (n = 3). The following factors were associated with the increased rate of RVF: segmental resection (p = 0.0355), low and very low anastomosis (p = 0.0010), lateral infiltration of the levator (p < 0.0001), concomitant hysterectomy or vaginal opening (p = 0.051), and prolonged operative time (p = 0.0010), Clostridioides difficile infection (p = 0.0001). Conclusions: RVFs occurred mainly after segmental resection (no other type of bowel resection), with very low anastomosis (5–6 cm from anal verge), in patients with levator ani infiltration and concomitant vaginal or uterine surgery; in such situations, discoid resection is the safer option. Despite the complexity of procedures, preventive strategies maintained a low overall RVF rate; no RVFs occurred in ultra low anastomoses (<5), indicating effective prevention with protective stomas. Full article
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10 pages, 200 KB  
Article
Pelvic Floor Dysfunction and Manometric Features in Pediatric Solitary Rectal Ulcer Syndrome
by Nihal Uyar Aksu, Altay Çelebi and Ayşen Uncuoğlu
J. Clin. Med. 2026, 15(6), 2140; https://doi.org/10.3390/jcm15062140 - 11 Mar 2026
Viewed by 481
Abstract
Background/Objectives: Solitary rectal ulcer syndrome (SRUS) is a rare benign disorder presenting with rectal bleeding, straining, and mucosal discharge. Its pathogenesis likely involves pelvic floor dysfunction, particularly dyssynergic defecation. Although studied in adults, pediatric data—specifically anorectal manometry (ARM) findings—remain limited. We aimed to [...] Read more.
Background/Objectives: Solitary rectal ulcer syndrome (SRUS) is a rare benign disorder presenting with rectal bleeding, straining, and mucosal discharge. Its pathogenesis likely involves pelvic floor dysfunction, particularly dyssynergic defecation. Although studied in adults, pediatric data—specifically anorectal manometry (ARM) findings—remain limited. We aimed to evaluate dyssynergic defecation in pediatric SRUS using ARM and analyze associated clinical, endoscopic, histopathological, and treatment data. Methods: A retrospective study of 24 children with biopsy-proven SRUS diagnosed between 2016 and 2024 was conducted. Clinical symptoms, colonoscopic, histopathological, treatment, and outcome data were reviewed. ARM was performed in 20 patients unresponsive to conservative treatment to assess anal pressures, rectal sensation, rectoanal inhibitory reflex, and balloon expulsion. Results: The median age was 13 years, with male predominance. Rectal bleeding was the most common symptom (95.8%). Colonoscopy revealed predominantly solitary ulcerative lesions 5–10 cm from the anal verge. Dyssynergic defecation was detected in 60% of patients, and only 25% could expel the balloon. Resting anal pressures were lower than reference values. Treatments included diet, laxatives, and topical agents, with partial or complete clinical response in approximately 60% of patients after 12 months. Conclusions: Pediatric SRUS is strongly associated with dyssynergic defecation. More pediatric-specific manometric studies are needed to optimize diagnosis and guide targeted therapies. Full article
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
14 pages, 659 KB  
Article
Clinical Complete Response and Organ Preservation Strategies in Rectal Cancer: A Real-World Single-Center Experience Clinical Complete Response and Organ Preservation in Rectal Cancer
by J. A. Encarnación, N. Ibáñez, I. De la Fuente, P. Ruiz, S. González, B. Quiles, M. Sánchez, Y. Bautista, C. Rodríguez, J. A. Nadal, M. Marín, G. Marín-Zafra, M. Guirao, Q. Hernández, J. Abrisqueta, I. Abellán, M. Montoya, A. Ono, G. Carbonell, L. Frutos, E. Ortiz, C. Manso, M. Royo-Villanova and J. L. Alonso-Romeroadd Show full author list remove Hide full author list
Cancers 2026, 18(5), 763; https://doi.org/10.3390/cancers18050763 - 27 Feb 2026
Viewed by 938
Abstract
Background: The management of rectal cancer has evolved toward response-adapted strategies, including organ preservation in selected patients achieving a clinical complete response (cCR) after neoadjuvant treatment. However, most available evidence derives from clinical trials, and data from real-world clinical practice remain limited. Methods: [...] Read more.
Background: The management of rectal cancer has evolved toward response-adapted strategies, including organ preservation in selected patients achieving a clinical complete response (cCR) after neoadjuvant treatment. However, most available evidence derives from clinical trials, and data from real-world clinical practice remain limited. Methods: We conducted a retrospective observational cohort study including consecutive patients with rectal adenocarcinoma treated at a tertiary referral center between January 2021 and December 2025. Baseline clinical, tumor-related, and treatment characteristics were collected. Tumor response was assessed using clinical, endoscopic, and radiological criteria. The primary endpoint was the rate of clinical complete response and the implementation of watch-and-wait strategies. Secondary endpoints included recurrence patterns and exploratory oncologic outcomes according to baseline tumor characteristics. Results: A total of 229 patients were identified, of whom 148 were evaluable for treatment response. Clinical complete response was documented in 56 patients (37.8%), and a watch-and-wait strategy was implemented in 42 patients (28.4%). Higher cCR rates were observed in patients with stage I–II disease and in tumors measuring < 4 cm on baseline magnetic resonance imaging, with cCR rates exceeding 55% in this subgroup. Tumors ≥ 4 cm showed substantially lower response rates. Clinical complete responses were observed across both short-course radiotherapy plus chemotherapy and long-course chemoradiotherapy regimens in patients with small tumors and early-stage disease. Tumor distance from the anal verge was not consistently associated with response. With a median follow-up of 26 months in the watch-and-wait group, five recurrences were observed, including three local recurrences. Conclusions: In this real-world cohort, baseline tumor size and clinical stage were the main determinants of clinical complete response and eligibility for organ-preservation strategies in rectal cancer. Small tumors (<4 cm) showed high response rates regardless of neoadjuvant regimen. These findings support response-adapted, individualized treatment strategies and highlight the importance of tumor burden in selecting candidates for non-operative management in routine clinical practice. Full article
(This article belongs to the Section Clinical Research of Cancer)
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14 pages, 2196 KB  
Article
Prospective, Multicentre Feasibility Study of Remote Colon Capsule Endoscopy Using the OMOM CC100 System
by Alexandra Agache, Ervin Toth, Niels Qvist, Miguel Mascarenhas, Wojciech Marlicz, Benedicte Schelde-Olesen, Miguel Mascarenhas-Saraiva, Maria Marlicz, Gabriele Wurm Johansson, Artur Nemeth and Anastasios Koulaouzidis
Diagnostics 2026, 16(1), 20; https://doi.org/10.3390/diagnostics16010020 - 20 Dec 2025
Viewed by 1587
Abstract
Background and Aims: Colon capsule endoscopy (CCE) provides a non-invasive alternative to traditional colonoscopy. This study evaluated the feasibility, safety, diagnostic yield (DY), and patient satisfaction of the OMOM CC100 CCE system, with special focus on fully remote (n = 30) and [...] Read more.
Background and Aims: Colon capsule endoscopy (CCE) provides a non-invasive alternative to traditional colonoscopy. This study evaluated the feasibility, safety, diagnostic yield (DY), and patient satisfaction of the OMOM CC100 CCE system, with special focus on fully remote (n = 30) and partially remote (n = 89) administration across four centres to advance decentralised models. Methods: This prospective, investigator-initiated, international multicentre feasibility study enrolled 119 patients aged 18–75 years at centres in Denmark, Sweden, Portugal, and Poland from July 2024 to May 2025. Indications included rectal bleeding, iron-deficiency anaemia, a positive faecal immunochemical test, changes in bowel habit, suspected inflammatory bowel disease (IBD), post-polypectomy or colorectal cancer (CRC) surgery surveillance, and a family history of CRC. The OMOM CC100 capsule was employed with a standardised bowel preparation regimen. Administration was fully remote in Denmark using the IntelliGI™ platform and partially remote (clinic ingestion, home completion) at the other sites. Primary outcomes encompassed procedure feasibility, completion rate (capsule excretion or anal verge visualisation), bowel cleanliness (Leighton-Rex scale ≥ 3), diagnostic yield, and patient satisfaction. Secondary measures included transit times, adverse events, and technical failures. Results: Median age was 55.7 years (65 males, 54 females). Overall completion rate was 79%, varying by centre: Sweden (90%), Portugal (81%), Denmark (80%), and Poland (63%). Adequate bowel cleanliness was achieved in 71% of cases. Diagnostic findings included polyps (25 patients), angioectasia (20), diverticulosis (17), and mucosal inflammation (17); 42% were normal. Fully remote administration yielded 80% completion and 89.7% satisfaction. No serious adverse events occurred; overall satisfaction was 81%, with 87% preferring home-based procedures. Conclusions: The OMOM CC100 CCE system is feasible, safe, with DY comparable to established systems. IntelliGI™-enabled remote administration promotes decentralised care, enhancing accessibility. Full article
(This article belongs to the Special Issue New Advances in Digestive Endoscopy)
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14 pages, 573 KB  
Article
Predictors and Long-Term Outcomes of Pathological Complete Response Following Neoadjuvant Treatment and Radical Surgery for Locally Advanced Rectal Cancer
by Dan Assaf, Yaacov Lawrence, Ofer Margalit, Einat Shacham-Shmueli, Lior Bear, Nadav Elbaz, Alexander Lebedayev, Edward Ram, Yasmin Anderson, Ofir Gruper, Michael Goldenshluger and Lior Segev
J. Clin. Med. 2025, 14(12), 4251; https://doi.org/10.3390/jcm14124251 - 15 Jun 2025
Cited by 3 | Viewed by 2352
Abstract
Background: Pathological complete response (pCR) following neoadjuvant therapy and surgery for locally advanced rectal cancer is associated with improved prognosis. Accurately predicting who will achieve pCR could theoretically eliminate the need for surgery for these patients. We aimed to compare pCR and non-pCR [...] Read more.
Background: Pathological complete response (pCR) following neoadjuvant therapy and surgery for locally advanced rectal cancer is associated with improved prognosis. Accurately predicting who will achieve pCR could theoretically eliminate the need for surgery for these patients. We aimed to compare pCR and non-pCR rectal cancer patients following neoadjuvant therapy, searching for clinical predictors for pCR and comparing oncological outcomes between these groups. Methods: This is a single-center retrospective analysis of all patients who underwent a curative-intent rectal resection between 2010 and 2020 for primary non-metastatic rectal cancer following neoadjuvant therapy. The cohort (263 patients) was divided into two groups according to the pathological results from surgery: the pCR group (53 patients) and the non-pCR group (210 patients). Results: The groups were similar in terms of baseline characteristics, clinical presentation, and staging, but tumors of the pCR group were significantly higher in the rectum (mean distance from the anal verge 7.92 cm versus 6.9 cm respectively, p = 0.04), and more of them were located at the posterior rectal wall (37.7% versus 24.3%, p = 0.049). Multivariate analysis found posterior location and tumor height to be significantly associated with pCR (OR 2.23, 95% CI 1.11–4.45, p = 0.023), (OR 1.14, 95% CI 1.03–1.27, p = 0.015). The 5-year overall survival was 95.6% in the pCR group compared with 87.5% in the non-pCR group (p = 0.09), and the 5-year disease-free survival was 92.7% versus 64.5%, respectively (p < 0.001). Conclusions: Tumor location at the posterior wall of the rectum and higher tumor location were found to be associated with pCR. Patients achieving pCR demonstrate improved prognosis compared with non-pCR patients. Full article
(This article belongs to the Special Issue Clinical Aspects and Outcomes in Contemporary Colorectal Surgery)
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18 pages, 14619 KB  
Review
Severe Rectal Stenosis as the First Clinical Appearance of a Metastasis Originating from the Bladder: A Case Report and Literature Review
by Claudiu Daha, Eugen Brătucu, Ioan Burlănescu, Virgiliu-Mihail Prunoiu, Hortensia-Alina Moisă, Ștefania Ariana Neicu and Laurențiu Simion
Life 2025, 15(5), 682; https://doi.org/10.3390/life15050682 - 22 Apr 2025
Cited by 2 | Viewed by 2458
Abstract
While locally advanced rectal cancer is the first clinical suspicion for severe rectal stenosis, in extremely unusual cases a lower bowel obstruction may be related to bladder metastasis. We present the case of a 64-year-old male who was admitted for occlusive rectal tumor [...] Read more.
While locally advanced rectal cancer is the first clinical suspicion for severe rectal stenosis, in extremely unusual cases a lower bowel obstruction may be related to bladder metastasis. We present the case of a 64-year-old male who was admitted for occlusive rectal tumor (4 cm from the anal verge), for which an emergency loop-colostomy was performed. After two inconclusive endoscopic biopsies, a transanal rectal tru-cut biopsy allowed for the detection of high-grade urothelial carcinoma with signet ring cells. Furthermore, primary origin was detected in a small bladder tumor. In imaging reassessment after neoadjuvant chemotherapy, regression of the lesions both from the bladder and rectum was observed. Radical surgery with total pelvic exenteration was considered in the absence of other secondary tumors, but the patient declined and continued with radiotherapy. Subsequently he developed malignant chylous ascites and unfortunately died three months later. Reviewing the literature, we found twenty-five cases of urothelial metastasis to the rectum, originating from the bladder, including this newly present case. Rectal metastasis of urothelial origin poses a two-fold challenge in terms of both diagnosis and treatment. Determining the specific features of this uncommon manifestation of a common disease will improve future approaches. Full article
(This article belongs to the Special Issue Pathophysiology, Diagnosis, and Treatments of Intestinal Diseases)
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14 pages, 511 KB  
Review
Geriatric Approaches to Rectal Cancer: Moving Towards a Patient-Tailored Treatment Era
by Carlo Vallicelli, Silvia Jasmine Barbara, Elisa Fabbri, Daniele Perrina, Giulia Griggio, Vanni Agnoletti and Fausto Catena
J. Clin. Med. 2025, 14(4), 1159; https://doi.org/10.3390/jcm14041159 - 11 Feb 2025
Cited by 3 | Viewed by 3186
Abstract
Rectal cancer is a significant global health concern, particularly amongst the elderly population, with rectal cancer accounting for approximately one-third of cancer cases in this population. Older adults often present with advanced disease stages and unique clinical manifestations, such as tumors closer to [...] Read more.
Rectal cancer is a significant global health concern, particularly amongst the elderly population, with rectal cancer accounting for approximately one-third of cancer cases in this population. Older adults often present with advanced disease stages and unique clinical manifestations, such as tumors closer to the anal verge and with greater size. Diagnosis typically involves a series of screening and imaging strategies, culminating in accurate staging through pelvic MRI, endoscopic ultrasound, and CT scan. Management of rectal cancer in older adults emphasizes individualized treatment plans that consider both the cancer stage and the patient’s overall health status, including frailty and comorbidities. A multidisciplinary approach, including a mandatory geriatric assessment, is essential for optimizing outcomes, in order to improve survival and quality of life for elderly patients with rectal cancer. Full article
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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26 pages, 4795 KB  
Review
Comprehensive Management of Bowel Endometriosis: Surgical Techniques, Outcomes, and Best Practices
by Angie Tsuei, Farr Nezhat, Nikki Amirlatifi, Zahra Najmi, Azadeh Nezhat and Camran Nezhat
J. Clin. Med. 2025, 14(3), 977; https://doi.org/10.3390/jcm14030977 - 3 Feb 2025
Cited by 12 | Viewed by 8697
Abstract
Bowel endometriosis is a complex condition predominantly impacting women in their reproductive years, which may lead to chronic pain, gastrointestinal symptoms, and infertility. This review highlights current approaches to the diagnosis and management of bowel endometriosis, emphasizing a multidisciplinary strategy. Diagnostic methods include [...] Read more.
Bowel endometriosis is a complex condition predominantly impacting women in their reproductive years, which may lead to chronic pain, gastrointestinal symptoms, and infertility. This review highlights current approaches to the diagnosis and management of bowel endometriosis, emphasizing a multidisciplinary strategy. Diagnostic methods include detailed patient history, physical examination, and imaging techniques like transvaginal ultrasound (TVUS) and magnetic resonance imaging (MRI), which aid in preoperative planning. Management options range from hormonal therapies for symptom relief to minimally invasive surgical techniques. Surgical interventions, categorized as shaving excision, disc excision, or segmental resection, depend on factors such as lesion size, location, and depth. Shaving excision is preferred for its minimal invasiveness and lower complication rates, while segmental resection is reserved for severe cases. This review also explores nerve-sparing strategies to reduce surgical morbidity, particularly for deep infiltrative cases close to the rectal bulb, anal verge, and rectosigmoid colon. A structured, evidence-based approach is recommended, prioritizing conservative surgery to avoid complications and preserve fertility as much as possible. Comprehensive management of bowel endometriosis requires expertise from both gynecologic and gastrointestinal specialists, aiming to improve patient outcomes while minimizing long-term morbidity. Full article
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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10 pages, 435 KB  
Article
Local Recurrence of Premalignant and Early Malignant Rectal Polyps Treated by TEM—A Single-Center Experience
by Muhammad Khalifa, Rachel Gingold-Belfer and Nidal Issa
J. Clin. Med. 2025, 14(1), 80; https://doi.org/10.3390/jcm14010080 - 27 Dec 2024
Viewed by 1206
Abstract
Background: Transanal endoscopic microsurgery (TEM) is a minimally invasive approach for excising rectal polyps, particularly those with high-grade dysplasia (HGD) or early-stage rectal cancer (T1). This study aimed to evaluate the recurrence risk and its associated factors in patients treated with TEM for [...] Read more.
Background: Transanal endoscopic microsurgery (TEM) is a minimally invasive approach for excising rectal polyps, particularly those with high-grade dysplasia (HGD) or early-stage rectal cancer (T1). This study aimed to evaluate the recurrence risk and its associated factors in patients treated with TEM for HGD and T1 rectal tumors. Methods: A retrospective review was conducted on 79 patients who underwent TEM for rectal lesions at Rabin Medical Center-Hasharon Hospital from 2005 to 2019. Data collected included demographics, tumor characteristics, and follow-up outcomes, with specific focus on tumor size, resection margins, mucin production, and distance from anal verge (AV). Separate and unified analyses were performed to assess the recurrence risk factors for both HGD and T1 patients. Results: Sixty-three patients were included in the final analysis. In the unified analysis, larger tumor size was significantly associated with increased recurrence risk (OR = 2.27, p = 0.028), and mucin production was a strong predictor of recurrence in the T1 group and combined analysis (p = 0.0012 and p = 0.014, respectively). Distance from AV demonstrated a borderline association with recurrence (p = 0.053). Conclusions: Larger tumor size and mucin production are significant predictors of recurrence in TEM-treated rectal polyps. Personalized follow-up and postoperative management are essential for patients with these risk factors to reduce the recurrence risk. Full article
(This article belongs to the Special Issue Colon and Rectal Surgery: Current Clinical Practice and Future Trends)
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8 pages, 561 KB  
Article
Association Between Chemotherapy-Induced Peripheral Neuropathy and Low Anterior Resection Syndrome
by Samantha M. Linhares, Kurt S. Schultz, Nathan A. Coppersmith, Andrew C. Esposito, Ira L. Leeds, Haddon J. Pantel, Vikram B. Reddy and Anne K. Mongiu
Cancers 2024, 16(21), 3578; https://doi.org/10.3390/cancers16213578 - 23 Oct 2024
Cited by 3 | Viewed by 2184
Abstract
Introduction: Low anterior resection syndrome (LARS) can be a debilitating condition that develops after undergoing sphincter-preserving surgery for rectal cancer. Chemotherapy-induced peripheral neuropathy is a common side effect of platinum-based chemotherapy agents used as systemic therapy for rectal cancer treatment. The purpose of [...] Read more.
Introduction: Low anterior resection syndrome (LARS) can be a debilitating condition that develops after undergoing sphincter-preserving surgery for rectal cancer. Chemotherapy-induced peripheral neuropathy is a common side effect of platinum-based chemotherapy agents used as systemic therapy for rectal cancer treatment. The purpose of this study was to determine the potential relationship between CIPN and LARS. Methods: This was a retrospective review of patients who underwent a low anterior resection for rectal cancer and received systemic therapy contacted at least six months from the most recent surgery. Eligible patients were called and completed the relevant surveys over the phone or email. Results: There was a total of 42 patients who completed the surveys with 33 (79%) having major LARS. Presence of a diverting ileostomy was the only significantly differentcharacteristic in those with major LARS versus those without. CIPN was independently associated with LARS (p = 0.046) on linear regression when controlling for neoadjuvant chemoradiation, diverting ileostomy and tumor distance from the anal verge. Conclusions: Developing severe CIPN is associated with developing LARS. Further studies evaluating the etiology behind this relationship should be conducted. Full article
(This article belongs to the Special Issue Patient-Centered Outcomes of Colorectal Cancer Surgery)
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10 pages, 213 KB  
Article
Risk Factors for Rectal Cancer Recurrence after Local Excision of T1 Lesions from a Decade-Long Multicenter Retrospective Study
by Yaron Rudnicki, Nitzan Goldberg, Nir Horesh, Assaf Harbi, Barak Lubianiker, Eraan Green, Guy Raveh, Moran Slavin, Lior Segev, Haim Gilshtein, Alexander Barenboim, Nir Wasserberg, Marat Khaikin, Hagit Tulchinsky, Nidal Issa, Daniel Duek, Shmuel Avital and Ian White
J. Clin. Med. 2024, 13(14), 4139; https://doi.org/10.3390/jcm13144139 - 16 Jul 2024
Cited by 3 | Viewed by 3483
Abstract
Background: Local surgical excision of T1 rectal adenocarcinoma is a well-established approach. Yet, there are still open questions regarding the recurrence rates and its risk factors. Methods: A retrospective multicenter study including all patients who underwent local excision of early rectal cancer with [...] Read more.
Background: Local surgical excision of T1 rectal adenocarcinoma is a well-established approach. Yet, there are still open questions regarding the recurrence rates and its risk factors. Methods: A retrospective multicenter study including all patients who underwent local excision of early rectal cancer with an open or MIS approach and had a T1 lesion from 2010 to 2020 in six academic centers. Data included demographics, preoperative studies, surgical findings, postoperative outcomes, and local and systemic recurrence. A univariable and multivariable logistic regression analysis was performed to identify risk factors for recurrence. Results: Overall, 274 patients underwent local excision of rectal lesions. Of them, 97 (35.4%) patients with a T1 lesion were included in the cohort. The mean age was 69 ± 10.5 years, and 42 (43.3%) were female. The mean distance of the lesions from the anal verge was 7.8 ± 3.2 cm, and the average tumor size was 2.7 ± 1.6 cm. Eighty-two patients (85%) had a full-thickness resection. Eight patients (8%) had postoperative complications. Kikuchi classification of submucosal (SM) involvement was reported in 29 (30%) patients. Twelve patients had SM1, two SM2, and fifteen SM3. Following pathology, 24 patients (24.7%) returned for additional surgery or treatment. The overall recurrence rate was 14.4% (14 patients), with 11 patients having a local recurrence and 6 having a systemic metastatic recurrence, 3 of which had both. The mean time for recurrence was 2.78 ± 2.8 years and the overall mortality rate was 11%. On univariable and multivariable logistic regression analysis of recurrence vs. non-recurrence groups, the strongest and most significant association and possible risk factors for recurrence were larger lesions (4.3 vs. 2.5 cm, p < 0.001) with an OR of 6.67 (CI—1.82–24.36), especially for tumors larger than 3.5 cm, mucinous histology (14.3% vs. 1.2%, p = 0.004, OR of 14.02, CI—1.13–173.85), and involved margins (41.7% vs. 16.2%, p = 0.003, OR of 9.59, CI—2.14–43.07). The open transanal excision (TAE) approach was also identified as a possible significant risk factor in univariant analysis, while SM3 level penetration showed only a trend. Conclusion: Surgical local excision of T1 rectal malignancy is a safe and viable option. Still, one in four patients received additional treatment. There is an almost 15% chance for recurrence, especially in large tumors, mucinous histology, or involved margin cases. These high-risk patients might warrant additional intervention and stricter surveillance protocols. Full article
(This article belongs to the Special Issue Anorectal Disease: Current Challenges in Diagnosis and Treatment)
13 pages, 508 KB  
Article
Win Statistics in Observational Cancer Research: Integrating Clinical and Quality-of-Life Outcomes
by Maria Vittoria Chiaruttini, Giulia Lorenzoni, Gaya Spolverato and Dario Gregori
J. Clin. Med. 2024, 13(11), 3272; https://doi.org/10.3390/jcm13113272 - 31 May 2024
Cited by 4 | Viewed by 2470
Abstract
Background: Quality-of-life metrics are increasingly important for oncological patients alongside traditional endpoints like mortality and disease progression. Statistical tools such as Win Ratio, Win Odds, and Net Benefit prioritize clinically significant outcomes using composite endpoints. In randomized trials, Win Statistics provide fair [...] Read more.
Background: Quality-of-life metrics are increasingly important for oncological patients alongside traditional endpoints like mortality and disease progression. Statistical tools such as Win Ratio, Win Odds, and Net Benefit prioritize clinically significant outcomes using composite endpoints. In randomized trials, Win Statistics provide fair comparisons between treatment and control groups. However, their use in observational studies is complicated by confounding variables. Propensity score (PS) matching mitigates confounding variables but may reduce the sample size, affecting the power of win statistics analyses. Alternatively, PS matching can stratify samples, preserving the sample size. This study aims to assess the long-term impact of these methods on decision making, particularly in colorectal cancer patients. Methods: A motivating example involves a cohort of patients from the ReSARCh observational study (2016–2021) with locally advanced adenocarcinoma of the rectum, situated up to 12 cm from the anal verge. These patients underwent either a watch-and-wait approach (WW) or trans-anal local excision (LE). Win statistics compared the effects of WW and LE on a composite outcome (overall survival, recurrence, presence of ostomy, and rectum excision). For matched win statistics, we used robust inference techniques proposed by Matsouaka et al. (2022), and for stratified win statistics, we applied the method proposed by Dong et al. (2018). A simulation study assessed the coverage probability of matched and stratified win statistics in balanced and unbalanced groups, calculating how often the confidence intervals included the true values of WR, NB, and WO across 1000 simulations. Results: The results suggest a better efficacy of the LE approach when considering efficacy outcomes alone (WR: 0.47 (0.01 to 1.14); NB: −0.16 (−0.34 to 0.02); and WO: 0.73 (0.5 to 1.05)). However, when QoL outcomes are included in the analyses, the estimates are closer to 1 (WR: 0.87 (0.06 to 2.06); WO: 0.93 (0.61 to 1.4)) and to 0 (NB: −0.04 (−0.25 to 0.17)), indicating a negative impact of the treatment effect of LE regarding the presence of ostomy and the excision of the rectum. Moreover, based on the simulation study, our findings underscore the superior performance of matched compared to stratified win statistics in terms of coverage probability (matched WR: 97% vs. stratified WR: 33.3% in a high-imbalance setting; matched WR: 98% vs. stratified WR: 34.4% in a medium-imbalance setting; and matched WR: 99.2% vs. stratified WR: 37.4% in a low-imbalance setting). Conclusions: In conclusion, our study sheds light on the interpretation of the results of win statistics in terms of statistical significance, providing insights into the application of pairwise comparison in observational settings, promoting its use to improve outcomes for cancer patients. Full article
(This article belongs to the Section Epidemiology & Public Health)
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14 pages, 262 KB  
Article
Robotic-Assisted versus Laparoscopic Surgery for Rectal Cancer: An Analysis of Clinical and Financial Outcomes from a Tertiary Referral Center
by Jasper Max Gebhardt, Neno Werner, Andrea Stroux, Frank Förster, Ioannis Pozios, Claudia Seifarth, Christian Schineis, Benjamin Weixler, Katharina Beyer and Johannes Christian Lauscher
J. Clin. Med. 2024, 13(6), 1795; https://doi.org/10.3390/jcm13061795 - 20 Mar 2024
Cited by 10 | Viewed by 4623
Abstract
Background: The popularity of robotic-assisted surgery for rectal cancer is increasing, but its superiority over the laparoscopic approach regarding safety, efficacy, and costs has not been well established. Methods: A retrospective single-center study was conducted comparing consecutively performed robotic-assisted and laparoscopic [...] Read more.
Background: The popularity of robotic-assisted surgery for rectal cancer is increasing, but its superiority over the laparoscopic approach regarding safety, efficacy, and costs has not been well established. Methods: A retrospective single-center study was conducted comparing consecutively performed robotic-assisted and laparoscopic surgeries for rectal cancer between 1 January 2016 and 31 September 2021. In total, 125 adult patients with sporadic rectal adenocarcinoma (distal extent ≤ 15 cm from the anal verge) underwent surgery where 66 were operated on robotically and 59 laparoscopically. Results: Severe postoperative complications occurred less frequently with robotic-assisted compared with laparoscopic surgery, as indicated by Clavien–Dindo classification grades 3b–5 (13.6% vs. 30.5%, p = 0.029). Multiple logistic regression analyses after backward selection revealed that robotic-assisted surgery was associated with a lower rate of total (Clavien–Dindo grades 1–5) (OR = 0.355; 95% CI 0.156–0.808; p = 0.014) and severe postoperative complications (Clavien–Dindo grades 3b–5) (OR = 0.243; 95% CI 0.088–0.643; p = 0.005). Total inpatient costs (median EUR 17.663 [IQR EUR 10.151] vs. median EUR 14.089 [IQR EUR 12.629]; p = 0.018) and surgery costs (median EUR 10.156 [IQR EUR 3.551] vs. median EUR 7.468 [IQR EUR 4.074]; p < 0.0001) were higher for robotic-assisted surgery, resulting in reduced total inpatient profits (median EUR −3.196 [IQR EUR 9.101] vs. median EUR 232 [IQR EUR 6.304]; p = 0.004). Conclusions: In our study, robotic-assisted surgery for rectal cancer resulted in less severe and fewer total postoperative complications. Still, it was associated with higher surgery and inpatient costs. With increasing experience, the operative time may be reduced, and the postoperative recovery may be further accelerated, leading to reduced surgery and total inpatient costs. Full article
(This article belongs to the Special Issue Clinical Management of Rectal Cancer)
14 pages, 3788 KB  
Article
Predicting the Feasibility of Curative Resection in Low Rectal Cancer: Insights from a Prospective Observational Study on Preoperative Magnetic Resonance Imaging Accuracy
by Cristian-Constantin Volovat, Dragos-Viorel Scripcariu, Diana Boboc, Simona-Ruxandra Volovat, Ingrid-Andrada Vasilache, Corina Lupascu-Ursulescu, Liliana Gheorghe, Luiza-Maria Baean, Constantin Volovat and Viorel Scripcariu
Medicina 2024, 60(2), 330; https://doi.org/10.3390/medicina60020330 - 15 Feb 2024
Cited by 1 | Viewed by 2833
Abstract
Background and Objectives: A positive pathological circumferential resection margin is a key prognostic factor in rectal cancer surgery. The point of this prospective study was to see how well different MRI parameters could predict a positive pathological circumferential resection margin (pCRM) in [...] Read more.
Background and Objectives: A positive pathological circumferential resection margin is a key prognostic factor in rectal cancer surgery. The point of this prospective study was to see how well different MRI parameters could predict a positive pathological circumferential resection margin (pCRM) in people who had been diagnosed with rectal adenocarcinoma, either on their own or when used together. Materials and Methods: Between November 2019 and February 2023, a total of 112 patients were enrolled in this prospective study and followed up for a 36-month period. MRI predictors such as circumferential resection margin (mCRM), presence of extramural venous invasion (mrEMVI), tumor location, and the distance between the tumor and anal verge, taken individually or combined, were evaluated with univariate and sensitivity analyses. Survival estimates in relation to a pCRM status were also determined using Kaplan–Meier analysis. Results: When individually evaluated, the best MRI predictor for the detection of a pCRM in the postsurgical histopathological examination is mrEMVI, which achieved a sensitivity (Se) of 77.78%, a specificity (Sp) of 87.38%, a negative predictive value (NPV) of 97.83%, and an accuracy of 86.61%. Also, the best predictive performance was achieved by a model that comprised all MRI predictors (mCRM+ mrEMVI+ anterior location+ < 4 cm from the anal verge), with an Se of 66.67%, an Sp of 88.46%, an NPV of 96.84%, and an accuracy of 86.73%. The survival rates were significantly higher in the pCRM-negative group (p < 0.001). Conclusions: The use of selective individual imaging predictors or combined models could be useful for the prediction of positive pCRM and risk stratification for local recurrence or distant metastasis. Full article
(This article belongs to the Section Oncology)
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9 pages, 506 KB  
Article
How to Study the Location and Size of Rectal Tumors That Are Candidates for Local Surgery: Rigid Rectoscopy, Magnetic Resonance, Endorectal Ultrasound or Colonoscopy? An Interobservational Study
by Anna Serracant, Beatriz Consola, Eva Ballesteros, Marta Sola, Francesc Novell, Noemi Montes and Xavier Serra-Aracil
Diagnostics 2024, 14(3), 315; https://doi.org/10.3390/diagnostics14030315 - 31 Jan 2024
Cited by 6 | Viewed by 2539
Abstract
1. Background. Preoperative staging of rectal lesions for transanal endoscopic surgery (TES) comprises digital rectal examination, intraoperative rigid rectoscopy (IRR), endorectal ultrasound (EUS), colonoscopy and rectal magnetic resonance imaging (rMRI). The gold standard for topographic features is IRR. Are the results of the [...] Read more.
1. Background. Preoperative staging of rectal lesions for transanal endoscopic surgery (TES) comprises digital rectal examination, intraoperative rigid rectoscopy (IRR), endorectal ultrasound (EUS), colonoscopy and rectal magnetic resonance imaging (rMRI). The gold standard for topographic features is IRR. Are the results of the other tests sufficiently reliable to eliminate the need for IRR? rMRI is a key test in advanced rectal cancer and is not operator-dependent. Description of anatomical landmarks is variable. Can we rely on the information regarding topographic features provided by all radiologists? 2. Materials and Methods. This is a concordance interobservational study involving four diagnostic tests of anatomical characteristics of rectal lesions (colonoscopy, EUS, rectal MRI and IRR), performed by four expert radiologists, regarding topographic rectal features with rMRI. 3. Results. Fifty-five rectal tumors were operated on by using TES. The distance of the tumor from the anal verge, location by quadrants, size by quadrants and size of tumor were assessed (IRR as gold standard). For most of the tumors, the correlation between IRR and colonoscopy or EUS was very good (ICC > 0.75); the correlation between rMRI and IRR in respect of the size by quadrants (ICC = 0.092) and location by quadrants (ICC = 0.292) was weak. Topographic landmarks studied by the expert radiologists had an excellent correlation, except for distance from the peritoneal reflection to the anal verge (ICC = 0.606). 4. Conclusions. Anatomical description of rectal lesions by IRR, EUS, colonoscopy and rMRI is reliable. Topographic data obtained by EUS and colonoscopy can serve as a reference to avoid IRR. Determination of these topographic data by rMRI is less reliable. As performed by the expert radiologists, the anatomical study by rMRI is accurate and reproducible. Full article
(This article belongs to the Special Issue Endoscopy in Diagnosis of Gastrointestinal Disorders)
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