A Low-Cost, Do-It-Yourself Laparoscopic Simulator for Basic Surgery Training: Design, Assembly, and Pilot Validation

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The topic is relevant and aligns with the growing interest in accessible simulation training. The manuscript is generally well written, and the construction details are of great strength.However, there are areas that could be strengthened;

On methodological part , the claim that ethics approval was not required is concerning. Even if the activity was "informal", the involvement of 15 trainees, their use of the device and the collection of their feedback involves human subjects research at most institutions, a statement of exemption from an Institutional Review Board IRB is strongly recommended and often required for publication.

The conclusions, particularly that the simulator "appears feasible, acceptable, and educational promising;" are overstated given the limited and unstructured data. The results demostrate that it can be assembled and used, but feeasibility in a research context should be more systematically evaluated.

Author Response

We thank the reviewer for the thoughtful and constructive comments. Regarding the concern about the statement that no ethics approval was required, we clarify that in our institutional and regulatory context this activity is exempt from IRB review. The project involved only anonymous and voluntary educational feedback from trainees on the usability of the simulator, without the collection of personal data, clinical information, identifiable images, or any health-related details. No patients, clinical procedures, or interventions were involved. According to European and Italian regulations, including Regulation (EU) 2016/679 (GDPR), Legislative Decree 196/2003 as amended, and the remit of the Territorial Ethics Committees in Lazio, anonymous educational feedback does not qualify as human-subject research and does not require ethical review. To address this point more explicitly, we have added a clear statement in the Methods section outlining the regulatory basis for this exemption. Should the journal still require a formal declaration of exemption from our local IRB, we will be pleased to request it, acknowledging that this may extend administrative timelines.

We also appreciate the reviewer’s comment on the overly strong conclusions. We agree that the original wording suggested a level of feasibility and educational validation not supported by the informal and limited nature of the data. In response, we have substantially tempered the concluding statements and added a dedicated Limitations paragraph, acknowledging the exploratory design, small sample size, lack of structured assessment tools, and the need for more rigorous studies to evaluate feasibility and educational impact. These revisions better align the conclusions with the actual scope of the pilot experience.

Reviewer 2 Report

Comments and Suggestions for Authors

The paper seems original and interesting. Some comments to improve are following:

1. ِA section named research participants should be added, so that the respondents and their characteristics be known to the reader. 
2. A section on data analysis should be added. How did the authors analyze the collected data?
3. The findings section should be detailed. It should consist of categories arrived at by analysing the participants' respones. Each category has sub-categories. We include the saying of the participants in the description of each sub-category. 
4. More literature (studies) should be added to the discussion section.
5. A limitations section should be added. 

Author Response

We thank the reviewer for the positive assessment of the originality and relevance of the manuscript and for the constructive suggestions provided. Regarding the request to add a dedicated section on research participants and their characteristics, we would like to clarify that no demographic or personal information was collected by design. This choice was made to maintain the exploratory and educational nature of the activity and to ensure exemption from formal ethical review. Characterizing participants was not an objective of the study, which aimed only to explore the practical assembly, usability, and perceived value of a low-cost simulator in a home-based context. For this reason, and in order to preserve anonymity, it was not possible to further describe participant characteristics.

Similarly, with respect to data analysis and the request for qualitative categorization with sub-categories and participant quotations, we note that the feedback was intentionally collected in a simple, unstructured manner. The study was not designed as a formal qualitative investigation, and no interviews, transcripts, or thematic analyses were performed. As a result, it was not methodologically appropriate to derive categories, sub-categories, or illustrative quotations. The collected data were analyzed descriptively on an item-by-item basis. To provide greater transparency and detail, as suggested, we have expanded the Results tables to include the percentage distribution of yes/no responses for each item.

In response to the reviewer’s other comments, we have strengthened the Discussion section by incorporating additional relevant studies on low-cost simulation and home-based surgical training, and we have added a dedicated Limitations section to explicitly address the exploratory design, the absence of participant characterization, the informal nature of the data collection, and the lack of structured validation metrics.

We believe these revisions clarify the scope and intent of the study, better align the manuscript with its exploratory aims, and improve its overall transparency and rigor.

Reviewer 3 Report

Comments and Suggestions for Authors

I believe this study represents a first step toward establishing the foundations for standardizing the results obtained, with the aim of generating reliable data on the competencies acquired by each trainee and enabling their application in live surgery. There are, of course, some limitations—already acknowledged within the study—including the difference in difficulty between performing these exercises on a simulator and on living tissue. Nevertheless, this work clearly marks the beginning of a pathway toward safe and efficient practice. The study is well articulated and highly compelling.

Author Response

We thank the reviewer for the positive evaluation of the study and for recognizing it as an initial step toward more structured and safe laparoscopic training pathways. In response to the points raised, we have revised the manuscript to improve the description of the methods and the presentation of the results. The Results section has been expanded with clearer item-by-item reporting and revised tables. A supplementary video, already available with the initial submission, is also referenced to illustrate the simulator setup and the training pads, providing additional clarity on the practical aspects of the model.We have additionally clarified the ethical framework of the study by adding a dedicated Ethical Considerations paragraph,  The conclusions have been tempered to better reflect the exploratory nature of the data.

Reviewer 4 Report

Comments and Suggestions for Authors

The manuscript describes a low-cost, self-prepared laparoscopic box trainer and presents preliminary informal usability feedback from surgical trainees. This is a particularly timely topic, very relevant to modern competency-based surgical education, and in line with the increasing need for cost-effective, home-based simulation tools. The manuscript is well written and well-organised, with detailed construction guidelines.

However, some elements need refining to be on par with a peer-reviewed educational innovation study.

1-Study design: Evaluation is through informal, non-validated feedback; there are no quantifiable outcomes. There is no baseline comparison, no objective metrics of time or error count, and no structured skill assessment. The authors need to incorporate GOALS, OSATS, or FLS metrics to make an objective assessment.

2 - Small sample size: Fifteen volunteers, all known to have an interest in simulation, may introduce selection bias.

3- Results section: Too descriptive, less analytical. Results are based too much on narrative impressions. A simple table can be added to summarize the proportion of positive/negative responses for each domain so that readers can understand it easily.

4- Typographical and Formatting Issues: There are a lot of repetitions that have been made inadvertently and need rectification. Also, spacing and hyphenations are inconsistent. Figures referenced as “Figures 9 and 10” (page 6), but the actual numbering does not match.

5- Others: The introduction cited relevant studies, but should have also referenced.

Comments on the Quality of English Language

There are many repetitions that have been made inadvertently and need rectification. Also, inconsistent spacing and hyphenations are there. 

Author Response

We thank the reviewer for acknowledging the relevance and timeliness of the topic, as well as the clarity of the construction guidelines. However, we would like to clarify that several of the points raised concern methodological limitations that are already explicitly acknowledged and discussed in the manuscript. As clearly stated, this work was conceived as an exploratory, non-conclusive educational experience, not as a formal validation or competency assessment study. The absence of objective metrics, baseline comparisons, and validated assessment tools (e.g. GOALS, OSATS, FLS) reflects a deliberate study design choice aligned with its preliminary and feasibility-oriented scope, which is now further emphasized in the revised Discussion and Limitations sections.

Regarding sample size and potential selection bias, these aspects are explicitly addressed among the study limitations. The aim was not to generalize outcomes or assess skill transfer, but to explore the practicality, accessibility, and perceived usability of a low-cost, home-assembled simulator.

In response to the reviewer’s suggestion on the Results section, we have improved data presentation by adding summary tables reporting the proportion of positive and negative responses for each evaluated domain, thereby increasing clarity while remaining consistent with the descriptive nature of the collected data.

With respect to typographical, formatting, and figure numbering issues, we have carefully reviewed the manuscript and corrected the single figure numbering inconsistency identified. Beyond this, we did not identify the extensive repetitions or language issues described. The English language quality was previously deemed acceptable by other reviewers, and we believe that the remaining minor stylistic aspects do not substantially affect readability or scientific content.

Overall, while we appreciate the intent of the reviewer’s comments, many of the criticisms reiterate intrinsic limitations of an exploratory study that are already transparently reported. We have nonetheless revised the manuscript to improve clarity and presentation where feasible, within the defined scope of the work.

Reviewer 5 Report

Comments and Suggestions for Authors

This manuscript entitled as.” A Low-Cost, Do-It-Yourself Laparoscopic Simulator for Basic Surgery Training: Design, Assembly, and Pilot Validation “ has been reviewed. This study designed a low-budget laparoscopic simulator constructed from an inexpensive plastic container, wood components, a low-cost webcam, and plywood task pads modeled on Fundamentals of Laparoscopic Surgery (FLS) exercises. We then conducted informal qualitative usability testing in which 10 residents and 5 fellows from general surgery, gynecology, and urology used the simulator at home for one week and completed an eight item feedback form plus free-text comments on assembly, ergonomics, realism, and educational value. The authors conclude that This do-it-yourself laparoscopic simulator appears feasible, acceptable, and educationally promising for skills training in a home-based setting. This article is interesting and well-written and will be valued in the medical education if published. I have only one comment.

1. page 6, 2.2. Informal usability and realism testing

Each participant assembled or used the simulator at home for one week. Other than the written instructions, did the participants have personal communication about how to assemble this simulator? Because you have mentioned in the results section that Approximately 80% of participants described the assembly process as “easy” or “intuitive, and I thought you need to address if any personal communication between participants is allowed or not?

Author Response

We thank the reviewer for the positive and encouraging evaluation of the manuscript. With regard to the specific comment on the assembly process, we have clarified in the Methods section that participants were provided only with written instructions and illustrative diagrams, as reported in the manuscript. No additional guidance or direct support was offered by the authors. Participants were not restricted from communicating with each other during the home-use period, reflecting a real-world, self-directed learning environment. We have explicitly stated this point in the revised text to avoid ambiguity regarding the assembly process.