How to write General Surgery Protocol?

Introduction
A General Surgery Protocol (also called a General Surgery Synopsis) is a structured plan for an MD, MS, or DNB thesis that outlines your study’s objectives, scope, and methods in investigating surgical conditions, techniques, or outcomes. A clear General Surgery Protocol guides your research and secures institutional approval.

1. Introduction to the Topic

• Define the surgical condition, procedure, or outcome measure under investigation (e.g., laparoscopic cholecystectomy outcomes, hernia repair techniques).

• Specify the patient population (age, comorbidities) and clinical setting (elective vs. emergency).

• Use both “General Surgery Protocol” and “General Surgery Synopsis” to refer to your document.

2. Demographics & Prevalence

• Identify affected patients (age, sex distribution, risk factors) and cite recent data on incidence or surgical volume.

• Highlight why this condition or procedure warrants study in your General Surgery Protocol.

3. Gap in Existing Knowledge

• Summarize current understanding of surgical outcomes, complication rates, or technique efficacy and pinpoint unanswered questions (e.g., optimal mesh type for incisional hernia).

• Explain how your General Surgery Synopsis will generate new evidence to address these gaps.

4. Need and Rationale for Study

• Explain why this research matters for postgraduate training (MD, MS, DNB) and patient care.

• Outline limitations in existing surgical techniques, protocols, or outcome data.

• State potential impact on operative standards, postoperative care, or guidelines.

• Mention alignment with national surgical safety or quality initiatives, if applicable.

5. Review of Literature

• Historical Background: trace the evolution of the surgical technique or management approach.

• Current State of Knowledge: summarize recent peer-reviewed studies on outcomes, techniques, and innovations.

• Key Findings: highlight methodologies (randomized trials, cohort studies, registries) and major results.

• Gaps in Literature: identify what existing General Surgery Synopses have overlooked.

• Relevance: show how your General Surgery Protocol builds on and extends prior work.

6. Lacunae in Literature

• List specific deficiencies or under-researched aspects (e.g., lack of long-term follow-up data).

• Explain how your General Surgery Synopsis addresses each lacuna.

7. Materials and Methods

• Source of Data: patient records, surgical registries, imaging archives, intraoperative recordings.

• Study Design: prospective, retrospective, comparative, cohort, randomized—state clearly in your General Surgery Protocol.

• Study Population: define inclusion and exclusion criteria (e.g., adults 18–70 years undergoing elective procedure; exclude re-operations).

• Study Period: precise start and end dates (mm/yyyy–mm/yyyy).

• Sample Size Calculation: present the formula, parameters (expected difference in outcome rates, α, power), and final number.

• Surgical Technique Description: step-by-step outline of the standardized procedure or intervention.

• Data Collection Procedures: how perioperative variables, complications, and outcomes will be recorded.

• Statistical Analysis: specify software, statistical tests (chi-square, Kaplan–Meier, logistic regression), and significance level (p < 0.05).

8. Ethical Considerations

• Informed Consent: procedures for obtaining voluntary, written consent from surgical patients.

• Confidentiality: anonymization of patient identifiers and secure data storage measures.

• Risk Minimization: perioperative safety protocols and monitoring plans.

• Ethics Committee Approval: name of the Institutional Review Board and approval ID.

9. Limitations of the Study

• Sample Size Constraints: potential under-representation of complex cases.

• Measurement Bias: variability in surgical technique or documentation.

• Selection Bias: referral patterns to your center or surgeon experience variability.

• Generalizability: applicability of findings to other institutions or surgeon skill levels.

10. Annexures

• Consent Form: template ensuring patients understand study aims, risks, and benefits before surgery.

• Patient Information Sheet: clear summary of study purpose, procedures, and contact details written in lay language.

• Data Collection Form: structured sheet for recording demographics, operative details, intraoperative findings, and postoperative outcomes consistently.

Conclusion
A concise General Surgery Protocol (General Surgery Synopsis) tailored for MD, MS, and DNB postgraduate students meets academic standards and provides a clear framework for conducting and presenting your surgical research. Cover each section above thoroughly to ensure scientific rigor and clarity.