Oncological Safety of Intrauterine Manipulator Use in Laparoscopic Hysterectomy for Endometrial Cancer: A Propensity Score-Matched Analysis
Abstract
1. Introduction
2. Materials and Methods
Statistical Analysis
3. Results
3.1. Patient Characteristics of the Entire Cohort
3.2. Survival Outcomes of the Entire Cohort
3.3. Patient Characteristics After Propensity Score Matching
3.4. Survival Outcomes After Propensity Score Matching
3.5. Univariate and Multivariate Analysis of DFS
3.6. Univariate and Multivariate Analysis of OS
4. Discussion
- Macroscopic dissemination. The insertion and manipulation of the device, whether balloon-based or not, may compromise the integrity of the myometrium, leading to iatrogenic uterine rupture and direct exposure of malignant tissue to the peritoneal cavity and surgical field. In addition, tumor fragments shed into the vagina during surgery may potentially spread into the abdominal cavity with gas insufflation following colpotomy.
- Microscopic dissemination. The use of an IUM markedly increases intrauterine pressure, producing global distension in line with Pascal’s principle. This effect is amplified by the sustained pressure required for uterine mobilization and colpotomy. The elevated intrauterine pressure may facilitate the passive migration of malignant cells through the myometrium into the fallopian tubes and lymphovascular spaces. Such changes in pressure dynamics may also alter the tumor microenvironment, favoring intraoperative hematogenous spread of tumor cells [10].
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
BMI | Body Mass Index |
CA-125 | Cancer antigen 125 |
CT | Computed tomography |
DFS | Disease-free survival |
EC | Endometrial cancer |
FIGO | International Federation of Obstetrics and Gynecology |
IUM | Intrauterine manipulator |
LACC | Laparoscopic Approach to Cervical Cancer |
LVSI | Lymphovascular space invasion |
MI | Myometrial Invasion |
OS | Overall survival |
PET/CT | Positron emission tomography combined with CT |
PSM | Propensity Score Matching |
RECIST | Response Evaluation Criteria In Solid Tumors |
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Characteristics | Laparoscopy (n = 168) | Laparotomy (n = 444) | p a Value |
---|---|---|---|
Age, y, median (range), n, (%) | 62.0 (27.0–85.0) | 63.5 (37.0–93.0) | 0.047 |
BMI, kg/m2, median (range) | 35.0 (18.0–54.0) | 33.9 (18.4–65.3) | 0.035 |
Pre-operative CA-125, (U/mL), median (range) | 15.0 (3.0–243.0) | 17.0 (2.8–455.0) | 0.042 |
Tumor size, cm, median (range) | 3.5 (0.2–10.0) | 4.0 (0.2–15.3) | <0.001 |
Histological types, n, (%) | 0.004 | ||
Endometrioid | 156 (92.9%) | 356 (80.2%) | |
Serous | 3 (1.8%) | 35 (7.9%) | |
Mucinous | 0 (0.0%) | 6 (1.4%) | |
Clear cell | 2 (1.2%) | 15 (3.4%) | |
Carcinosarcoma | 4 (2.4%) | 18 (4.1%) | |
Others b | 3 (1.8%) | 14 (3.2%) | |
FIGO stage c, n, (%) | 0.002 | ||
IA | 127 (75.6%) | 268 (60.4%) | |
IB | 21 (12.5%) | 66 (14.9%) | |
II | 7 (4.2%) | 28 (6.3%) | |
III | 13 (7.7%) | 82 (18.5%) | |
FIGO grade | <0.001 | ||
1 | 103 (61.3%) | 150 (33.8%) | |
2 | 41 (24.4%) | 148 (33.3%) | |
3 | 24 (14.3%) | 146 (32.9%) | |
Depth of myometrial invasion, n, (%) | <0.001 | ||
None | 25 (14.9%) | 36 (8.1%) | |
<50% | 115 (68.5%) | 278 (62.6%) | |
≥50% | 28 (16.7%) | 130 (29.3%) | |
LVSI, n, (%) | 0.019 | ||
Absent | 137 (81.5%) | 319 (71.8%) | |
Present | 31 (18.5%) | 125 (28.2%) | |
Pelvic Lymphadenectomy, n, (%) | 0.003 | ||
Yes | 124 (73.8%) | 378 (85.1%) | |
No | 44 (26.2%) | 65 (14.6%) | |
Para-aortic Lymphadenectomy, n, (%) | <0.001 | ||
Yes | 53 (31.5%) | 326 (73.4%) | |
No | 115 (68.5%) | 116 (26.1%) | |
Pelvic LN harvested, median (range) | 20.0 (2.0–54.0) | 22.0 (2.0–82.0) | 0.067 |
Para-aortic LN harvested, median (range) | 13.0 (1.0–45.0) | 18.0 (1.0–51.0) | <0.001 |
Peritoneal washing cytology, n, (%) | 0.717 | ||
Negative | 166 (98.8%) | 436 (98.2%) | |
Positive | 1 (0.6%) | 2 (0.5%) | |
Unknown | 1 (0.6%) | 6 (1.4%) | |
Adjuvant treatment, n, (%) | <0.001 | ||
None | 65 (38.7%) | 105 (23.6%) | |
Chemotherapy | 4 (2.4%) | 23 (5.2%) | |
Radiotherapy | 75 (44.6%) | 193 (43.5%) | |
Chemotherapy and radiotherapy | 24 (14.3%) | 123 (27.7%) | |
Recurrence, n, (%) | 0.394 | ||
Yes | 17 (10.1%) | 58 (13.1%) | |
No | 151 (89.9%) | 386 (86.9%) | |
Recurrence site, n, (%) | 0.613 | ||
Local | 7 (41.1%) | 25 (43.1%) | |
Distant | 6 (35.2%) | 27 (46.5%) | |
Local+Distant | 4 (23.7%) | 6 (10.4%) |
Characteristics | Laparoscopy (n = 168) | Laparotomy (n = 168) | p Value a |
---|---|---|---|
Age, y, median (range), n, (%) | 62.0 (27.0–85.0) | 63.0 (37.0–85.0) | 0.712 |
BMI, kg/m2, median (range) | 35.0 (18.0–54.0) | 35.5 (18.4–65.3) | 0.086 |
Pre-operative CA-125, (U/mL), median (range) | 15.0 (3.0–243.0) | 16.0 (2.8–397.0) | 0.171 |
Tumor size, cm, median (range) | 3.5 (0.2–10.0) | 3.7 (0.5–15.3) | 0.643 |
Histological types, n, (%) | 0.210 | ||
Endometrioid | 156 (92.9%) | 158 (94.0%) | |
Serous | 3 (1.8%) | 6 (3.6%) | |
Mucinous | 0 (0.0%) | 2 (1.2%) | |
Clear cell | 2 (1.2%) | 0 (0.0%) | |
Carcinosarcoma | 4 (2.4%) | 1 (0.6%) | |
Others b | 3 (1.8%) | 1 (0.6%) | |
FIGO stage c, n, (%) | 0.655 | ||
IA | 127 (75.6%) | 128 (76.2%) | |
IB | 21 (12.5%) | 22 (13.1%) | |
II | 7 (4.2%) | 3 (1.8%) | |
III | 13 (7.7%) | 15 (9%) | |
FIGO grade | 0.002 | ||
1 | 103 (61.3%) | 72 (42.9%) | |
2 | 41 (24.4%) | 57 (33.9%) | |
3 | 24 (14.3%) | 39 (23.2%) | |
Depth of myometrial invasion, n, (%) | 0.064 | ||
None | 25 (14.9%) | 11 (6.5%) | |
<50% | 115 (68.5%) | 114 (67.9%) | |
≥50% | 28 (16.7%) | 43 (25.6%) | |
LVSI, n, (%) | 0.056 | ||
Absent | 137 (81.5%) | 119 (70.8%) | |
Present | 31 (18.5%) | 49 (29.2%) | |
Pelvic Lymphadenectomy, n, (%) | 0.084 | ||
Yes | 124 (73.8%) | 137 (81.5%) | |
No | 44 (26.2%) | 31 (18.5%) | |
Para-aortic Lymphadenectomy, n, (%) | <0.001 | ||
Yes | 53 (31.5%) | 125 (74.4%) | |
No | 115 (68.5%) | 43 (25.6%) | |
Pelvic LN harvested, median (range) | 20.0 (2.0–54.0) | 27.0 (10.0–82.0) | <0.001 |
Para-aortic LN harvested, median (range) | 13.0 (1.0–45.0) | 18.0 (2.0–44.0) | <0.001 |
Peritoneal washing cytology, n, (%) | 0.606 | ||
Negative | 166 (98.8%) | 167 (99.4%) | |
Positive | 1 (0.6%) | 0 (0.0%) | |
Unknown | 1 (0.6%) | 1 (0.6%)4%) | |
Adjuvant treatment, n, (%) | 0.013 | ||
None | 65 (38.7%) | 41 (24.4%) | |
Chemotherapy | 4 (2.4%) | 4 (2.4%) | |
Radiotherapy | 75 (44.6%) | 104 (61.9%) | |
Chemotherapy and radiotherapy | 24 (14.3%) | 19 (11.3%) | |
Recurrence, n, (%) | 0.028 | ||
Yes | 17 (10.1%) | 10 (6.0%) | |
No | 151 (89.9%) | 158 (94.0%) | |
Recurrence site, n, (%) | 0.514 | ||
Local | 7 (41.1%) | 5 (50%) | |
Distant | 6 (35.2%) | 2 (20%) | |
Local+Distant | 4 (23.7%) | 3 (30%) |
Variable | Univariate HR (95% CI) | p Value | Multivariate HR (95% CI) | p Value |
---|---|---|---|---|
Age | 1.01 (0.99–1.04) | 0.21 | – | – |
BMI | 1.02 (0.96–1.06) | 0.25 | – | – |
Pre-operative CA-125 | 1.00 (0.99–1.01) | 0.33 | – | – |
Tumor size | 1.03 (0.98–1.08) | 0.22 | – | – |
Histologic type | ||||
Endometrioid | 1.00 (–) | – | – | |
Non-endometrioid | 3.10 (1.80–5.35) | <0.001 | 3.57 (1.80–7.07) | <0.001 |
FIGO Stage | ||||
I (Ref.) | 1.00 (–) | – | – | – |
II | 1.40 (0.70–2.80) | 0.30 | – | – |
III | 2.85 (1.60–5.10) | <0.001 | 3.06 (1.59–5.87) | <0.001 |
Grade | ||||
1 (Ref.) | 1.00 (–) | – | – | – |
2 | 1.65 (0.90–3.01) | 0.11 | – | – |
3 | 2.20 (1.20–4.05) | 0.01 | 2.63 (1.10–6.27) | 0.03 |
Positive cytology | 0.95 (0.30–3.05) | 0.93 | – | – |
LVSI, Present | 1.50 (1.01–2.25) | 0.04 | 1.24 (0.72–2.13) | 0.44 |
Depth of myometrial invasion, ≥50 | 1.15 (0.75–1.75) | 0.50 | – | – |
Methods of surgery, Laparotomy | 0.60 (0.40–0.95) | 0.03 | 0.51 (0.29–0.92) | 0.03 |
Adjuvant treatment | ||||
None (Ref.) | 1.00 (–) | – | – | – |
Radiotherapy | 1.50 (0.80–2.80) | 0.20 | – | – |
Chemotherapy | 2.40 (1.20–4.80) | 0.01 | 2.69 (0.77–9.35) | 0.12 |
Chemoradiotherapy | 1.35 (0.70–2.70) | 0.35 | – | – |
Variable | Univariate HR (95% CI) | p Value | Multivariate HR (95% CI) | p Value |
---|---|---|---|---|
Age | 1.02 (0.99–1.06) | 0.18 | – | – |
BMI | 1.01 (0.97–1.08) | 0.19 | – | – |
Pre-operative CA-125 | 1.00 (0.99–1.01) | 0.40 | – | – |
Tumor size | 1.04 (0.98–1.11) | 0.20 | – | – |
Histologic type | ||||
Endometrioid | 1.00 (–) | – | – | |
Non-endometrioid | 4.50 (2.20–9.10) | <0.001 | 5.12 (2.26–11.58) | <0.001 |
FIGO Stage | ||||
I (Ref.) | 1.00 (–) | – | – | – |
II | 1.40 (0.60–3.30) | 0.40 | – | – |
III | 3.00 (1.50–6.00) | <0.001 | 2.98 (1.41–6.31) | <0.001 |
Grade | ||||
1 (Ref.) | 1.00 (–) | – | – | – |
2 | 1.50 (0.70–3.30) | 0.29 | – | – |
3 | 3.10 (1.50–6.40) | <0.001 | 4.51 (1.27–15.99) | 0.02 |
Positive cytology | 1.10 (0.30–3.90) | 0.90 | – | – |
LVSI, Present | 1.35 (0.75–2.45) | 0.31 | – | – |
Depth of myometrial invasion, ≥50 | 1.25 (0.70–2.20) | 0.45 | – | – |
Methods of surgery, Laparotomy | 0.75 (0.40–1.40) | 0.36 | – | – |
Adjuvant treatment | ||||
None (Ref.) | 1.00 (–) | – | – | – |
Radiotherapy | 1.40 (0.70–3.00) | 0.30 | – | – |
Chemotherapy | 1.70 (0.80–3.70) | 0.16 | – | – |
Chemoradiotherapy | 1.20 (0.50–2.80) | 0.65 | – | – |
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Yalcin, Y.; Kosan, B.; Yalcin, S.; Ozerkan, K. Oncological Safety of Intrauterine Manipulator Use in Laparoscopic Hysterectomy for Endometrial Cancer: A Propensity Score-Matched Analysis. Medicina 2025, 61, 1820. https://doi.org/10.3390/medicina61101820
Yalcin Y, Kosan B, Yalcin S, Ozerkan K. Oncological Safety of Intrauterine Manipulator Use in Laparoscopic Hysterectomy for Endometrial Cancer: A Propensity Score-Matched Analysis. Medicina. 2025; 61(10):1820. https://doi.org/10.3390/medicina61101820
Chicago/Turabian StyleYalcin, Yakup, Bahadir Kosan, Serenat Yalcin, and Kemal Ozerkan. 2025. "Oncological Safety of Intrauterine Manipulator Use in Laparoscopic Hysterectomy for Endometrial Cancer: A Propensity Score-Matched Analysis" Medicina 61, no. 10: 1820. https://doi.org/10.3390/medicina61101820
APA StyleYalcin, Y., Kosan, B., Yalcin, S., & Ozerkan, K. (2025). Oncological Safety of Intrauterine Manipulator Use in Laparoscopic Hysterectomy for Endometrial Cancer: A Propensity Score-Matched Analysis. Medicina, 61(10), 1820. https://doi.org/10.3390/medicina61101820