-->PONE-D-26-02165-->-->Protocol for the Development of a Procedure Guide on Laparoscopic Cholecystectomy: Beyond Bile Duct Injury Prevention-->-->PLOS One

Dear Dr. Ramírez-Giraldo,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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Kind regards,

Lovenish Bains, MS, FNB, FACS, FRCS (Glas), FICS, FIAGES

Academic Editor

PLOS One

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Reviewers’ comments:

Reviewer’s Responses to Questions

-->Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.-->

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

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-->2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.-->

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Partly

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-->3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.-->

Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: No

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-->4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.-->

Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

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-->5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.-->

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

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-->6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: I would like to congratulate the authors on this well-designed protocol. The topic is highly clinically relevant. Although laparoscopic cholecystectomy remains the gold standard for the treatment of gallstone disease, the incidence of major bile duct and/or vasculobiliary injuries has not substantially decreased over the past two decades, despite the introduction and promotion of safety measures such as the Critical View of Safety (CVS) and broader initiatives including the Culture of Safety in Cholecystectomy (COSIC).

Given the very high volume of laparoscopic cholecystectomies performed worldwide, even an injury rate in the range of 0.4–0.6% translates into a significant burden for patients and healthcare systems. Severe biliary injuries are associated with considerable short- and long-term morbidity, the need for complex reparative procedures, impaired quality of life, and increased costs.

I hope that this work will contribute to standardizing intraoperative decision-making and surgical strategy, promoting a shared approach to difficult scenarios and, ultimately, improving patient safety.Overall, I believe the manuscript is suitable for acceptance in its current form. The only minor revision I would suggest is to reconsider the wording in the sentence “despite its routine nature, laparoscopic cholecystectomy is not without risk” (line 105). The term “routine” may inadvertently convey a sense of triviality, which contrasts with the manuscript’s focus on patient safety. A more neutral alternative could be: “Despite being frequently performed, laparoscopic cholecystectomy is not without risk.”

Reviewer #2: Main concerns and modification suggestions:

Use of ChatGPT in literature search strategy (key issue): On page 12, the authors mention, "Systematic literature searches will be performed with the assistance of ChatGPT 5.0." This is a serious methodological flaw and does not comply with the standards of systematic reviews. Using generative AI tools for systematic literature searches is unreliable and may lead to hallucinations (producing false literature), omissions, and reproducibility issues. PLOS ONE requires methods to be transparent and reproducible. This method must be removed and replaced with standard, reportable search strategies. Suggestion: Provide a detailed description of the search databases (such as PubMed/MEDLINE, Embase, Cochrane Library), search terms (including MeSH terms and free terms), search time frame, language restrictions, etc. It can be mentioned that professional medical librarians will be consulted to ensure the comprehensiveness of the search.

Specific operational details of the Delphi technique:

Consensus threshold: Setting "≥50% participation rate and ≥80% agreement rate" as the consensus standard is reasonable. However, it needs to be clarified how to handle cases where the participation rate is exactly on the 50% edge (for example, whether reminders will be sent after the first round to increase participation).

Composition and representativeness of the expert panel: Although a large number of experts (about 60) are listed, the criteria for expert selection (such as based on publication records, years of clinical experience, regional representation, etc.) need to be described in more detail to demonstrate their professionalism. Additionally, consideration should be given to including methodologists, patient representatives, or nursing representatives to enhance the comprehensiveness and applicability of the guidelines (AGREE II domain 3).

Role of "critical/important" classification: It is mentioned that experts will categorize issues as "critical," "important," or "not important." How this classification will affect subsequent processes (for example, whether only "critical" and "important" issues will be synthesized for evidence and recommendations) needs to be clarified.

Scope definition and clinical issues: It is clear that preoperative, postoperative management, and special populations are explicitly excluded. However, the scope of "intraoperative decision-making" is very broad. It is recommended that the authors provide 1-2 proposed PICO questions in the main text or supplementary materials to help readers better understand the specific concerns of the guidelines.

Evidence synthesis plan: The possibility of network meta-analysis (NMA) is mentioned. Given that comparative studies of laparoscopic cholecystectomy may lack directly comparable randomized controlled trials, the feasibility of conducting NMA needs to be assessed. The authors should clarify under what conditions (such as at least one common comparative group, study homogeneity, etc.) NMA will be considered; otherwise, it should be clearly stated that primarily paired meta-analysis or narrative summary will be conducted.

2. Presentation of results and data (for the protocol):

Main concerns and modification suggestions:

Data availability statement: The current statement "Deidentified research data will be made publicly available when the study is completed and published." is too vague. For a protocol, it should specify what types of data will be shared upon completion (for example, anonymized response data from the Delphi survey, extracted data tables from the systematic review, GRADE evidence profile tables, etc.), and the planned sharing platforms (such as OSF, Figshare, or as supplementary files to the article). This aligns with best practices in open science.

Ethics statement: Currently listed as "N/A." However, Delphi research involves collecting data and opinions from expert participants, which typically requires ethical review exemption or approval. The authors should confirm and supplement the corresponding ethical statement (for example, stating that the study has received approval or exemption from the ethics committee of XX institution, or that it does not require ethical approval because it falls under methodological research for guideline development, and clarify the reasons).

3. Discussion and conclusion:

Advantages: Clearly articulates the gaps this guideline aims to fill and its potential impact.

Main concerns and modification suggestions:

Critique of existing guidelines: Pages 13-14 mention that existing guidelines "lack methodological rigor." This assertion needs to be supported more cautiously and specifically. The cited references 20 and 21 (Agresta et al., 2015; Romero et al., 2021) are also consensus-based guidelines or Delphi studies. It could be pointed out that they have shortcomings in comprehensiveness or coverage of certain technical details, rather than broadly criticizing their methodological rigor unless there is clear assessment (such as using the AGREE II tool) to support this claim.

Limitations: As a protocol, the discussion section should include a discussion of the potential limitations of this protocol design. For example: reliance on published literature may not cover all unpublished surgical techniques; although the Delphi expert panel is international, it may still not represent practice differences across all regions; after the guidelines are developed, their actual adoption and implementation effects need to be validated by subsequent research.

Reviewer #3: This protocol addresses an important and well‑recognized gap in current surgical guidelines by proposing a comprehensive, evidence‑based approach to the intraoperative conduct of laparoscopic cholecystectomy. The methodology is generally rigorous, incorporating AGREE II, PRISMA, GRADE, and Delphi processes. The topic is clinically relevant and could have meaningful international impact.

However, substantial revisions are required to improve clarity, focus, and methodological transparency.

1. Move all of the contributors to a small table format and attach as supplementary material

2. Clarity on conflict management - describe how conflicts will be addressed, monitored, and managed.

3. Clarify how or if AI outputs will be validated by human information specialists

4. Standardizing ALL intra-op decisions seems unmanageable but possibly define a tighter scope of boundaries (ie. use of cholangiography, bailout methods like subtotal or fenestration, or different phases of the procedure)

5. 50% participation seems too low and should be more around 70% for validity

6. How will unresolved items be handled? what would criteria be to drop, modify or differ questions/recommendations?

7. Are there public or private stakeholders?

8. Provide rationale on size and composition of the expert panel

Reviewer #4: The authors plan to develop guidelines for safe laparoscopic cholecystectomy as most of the current guidelines focus only on bile duct injury prevention. The plan of developing guidelines is well formulated and it is in accordance with the current practices for development of similar guidelines

Reviewer #5: Though there is vast knowledge and guidelines available on the topic of the study, the authors are right in pointing out the lack of globally applicable and holistic guidelines that address the subject of laparoscopic cholecystectomy.

However, the proposed partcipants from membership of surgical society from a single country may not adequately address the topic for global consumption. At most, the study as proposed would serve as a national or regional guideline on the subject.

Further, the authors mention recruiting external experts via invitation by a steering committee. The criteria for inclusion of international experts is not well elaborated. The authors also mention ensuring broad representation ’across surgical specialties’ yet the topic is a guideline on a subspecialized area of general surgery. The aim should not be broad representation but subspecialized representation from the HPB/general surgeons with considerable experience on the subject.

I recommend that the authors tap into the memebrship of cross-border or international bodies such as IHBA or ILTS for the study to achieve the objectives and serve as global guideline or protocol on the subject.

Reviewer #6: Dear Author,

This manuscript presents a protocol for the development of an evidence-based procedural guideline for laparoscopic cholecystectomy, focusing on intraoperative technical conduct beyond bile duct injury prevention. The topic is clinically important and globally relevant, given the volume of procedures performed worldwide and ongoing efforts to standardize surgical safety practices.

The protocol demonstrates thoughtful planning and incorporates established methodological frameworks (AGREE II, PRISMA, GRADE, ACCORD, Delphi methodology). The international composition of the Guideline Development Group is a notable strength and enhances the credibility and potential global applicability of the initiative.

However, several areas require clarification to ensure methodological transparency, reproducibility, and clear differentiation from existing guidelines.

Major Comments

1. Clarification of Added Value Compared to Existing Guidelines

The manuscript states that current guidelines insufficiently address intraoperative technical conduct. While this may be true, the manuscript would benefit from a clearer and more structured comparison with major existing guidelines (e.g., WSES 2020 guidelines, multi-society safe cholecystectomy consensus, prior consensus-based recommendations).

To strengthen the justification for this initiative, the authors should:

• Explicitly outline how the proposed guideline differs in scope.

• Clarify whether it will cover a broader intraoperative workflow than existing initiatives.

• Specify how methodological rigor (e.g., systematic use of GRADE for all recommendations) distinguishes this effort.

A concise comparative table may improve clarity and strengthen the manuscript’s rationale.

2. Role of ChatGPT in Systematic Review Methodology

The manuscript indicates that systematic literature searches will be performed with assistance from ChatGPT 5.0. While innovative, this statement requires clarification to avoid concerns about reproducibility and methodological rigor.

The authors should clarify:

• Whether ChatGPT will assist only in drafting preliminary search strategies.

• Whether final search strategies will be validated by a trained information specialist or librarian.

• How transparency and reproducibility will be ensured.

• Whether complete search strategies will be provided as supplementary material.

Providing this clarification will strengthen confidence in the systematic review methodology.

3. Delphi Process and Participation Threshold

The defined consensus threshold (≥50% participation and ≥80% agreement) should be justified with reference to Delphi methodology standards. In particular, the rationale for a 50% participation threshold warrants explanation, as participation rates may influence representativeness.

The authors should also clarify how attrition between Delphi rounds will be handled and whether subgroup analyses (e.g., geographic representation, practice setting) are planned to ensure balanced input.

4. Clarification of Scope Boundaries

The guideline excludes preoperative and postoperative management, yet anesthesiologists are included for perioperative considerations. It would be helpful to clarify whether anesthesia-related aspects are strictly limited to intraoperative management.

Including one example PICO-formulated clinical question would enhance transparency and help readers understand the intended granularity and scope of recommendations.

5. Use of Existing Systematic Reviews

The manuscript proposes relying on systematic reviews published within the past five years when available. The authors should clarify:

• Whether updated searches will be conducted before adopting conclusions.

• How methodological quality will be assessed before incorporating existing reviews.

• How overlapping or conflicting reviews will be managed.

Clarifying these criteria will strengthen methodological consistency.

6. Data Availability Statement

As this is a protocol without primary data generation, the data availability statement should be clearly aligned with PLOS ONE’s policy for protocols and explicitly state that no datasets were generated or analyzed at this stage.

Minor Comments

1. “Paso 7” should be revised to “Stage 7.”

2. Minor typographical and spacing inconsistencies should be corrected.

3. Figures 1–3 would benefit from brief descriptive explanations in the main text.

4. The registration section should include the date of registration and confirm that it was prospectively registered.

This protocol addresses an important gap in the standardization of laparoscopic cholecystectomy technique. With clarification regarding AI-assisted search methodology, consensus thresholds, scope boundaries, and differentiation from existing guidelines, the manuscript would be substantially strengthened.

I encourage revision addressing the points above.

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-->7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.-->

Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes:Matthew Factor

Reviewer #4: Yes:Sanjeev Kumar Gupta

Reviewer #5: No

Reviewer #6: Yes:DR MEGHA TANDON

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Protocol for the Development of a Procedure Guide on Laparoscopic Cholecystectomy: Beyond Bile Duct Injury Prevention

PONE-D-26-02165R1

Dear Dr. Ramírez-Giraldo,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Wenguo Cui, Ph.D

Academic Editor

PLOS One

Additional Editor Comments (optional):

Reviewers’ comments:

Reviewer’s Responses to Questions

-->Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.-->

Reviewer #2: Yes

Reviewer #3: Yes

**********

-->2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.-->

Reviewer #2: Yes

Reviewer #3: Yes

**********

-->3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.-->

Reviewer #2: Yes

Reviewer #3: Yes

**********

-->4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.-->

Reviewer #2: Yes

Reviewer #3: Yes

**********

-->5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.-->

Reviewer #2: Yes

Reviewer #3: Yes

**********

-->6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #2: The revised manuscript has fully addressed all the reviewers’ comments, the methodological flaws have been corrected, the ethical and data sharing statements have been improved, and the wording in the discussion section has become more precise. As a reviewer, I believe that the current quality of this manuscript’s revisions has reached the publication standards.

Reviewer #3: Based on my review of the revised manuscript, the authors have adequately addressed the reviewers’ comments, and I have no further concerns.

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-->7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.-->

Reviewer #2: No

Reviewer #3: No

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