Improving Risk Documentation in Laparoscopic Cholecystectomy: A Single-Centre Before-and-After Study of a Pre-printed Consent Form

TL;DR

A pre-printed consent form improved risk documentation for laparoscopic cholecystectomy, boosting compliance from 0% to 100% and enhancing patient safety and trust.

Contribution

A pre-printed consent form significantly improved risk documentation compliance in laparoscopic cholecystectomy procedures.

Findings

Baseline risk documentation compliance was 0%, with critical risks like adhesional obstruction and death rarely recorded.

After implementing the pre-printed form, all 23 forms achieved 100% compliance with predefined risks.

Surgeons found the new form time-saving, clear, and helpful in building patient trust.

Abstract

Introduction: Informed consent is essential in surgery, requiring patients to receive clear information about risks, benefits, and alternatives. For laparoscopic cholecystectomy, the most commonly performed general surgical procedure in the UK, studies highlight inconsistencies in risk disclosure, with frequent omission of uncommon but serious complications. Such omissions may compromise patient understanding, shared decision-making, and medico-legal protection. This study aimed to assess whether a pre-printed, procedure-specific consent form could improve compliance with risk documentation.

Methods: We performed a retrospective, single-centre, before-and-after study at a UK district general hospital. Consecutive adult patients undergoing laparoscopic cholecystectomy were included across two study periods: baseline (December 2023-June 2024, n = 46) and post-intervention (November-December 2024, n = 23). Consent forms were reviewed against a predefined set of nationally recommended risks, derived from guidance and local consensus. The intervention consisted of a pre-printed consent form that listed these risks in a structured checklist format, with space for additional notes. The primary outcome was complete documentation of all predefined risks. Informal feedback from surgeons was also collected and thematically summarised.

Results: At baseline, none of the 46 forms achieved full compliance (0%). While common risks such as bleeding, infection, and conversion to open surgery were documented universally, other important risks were inconsistently recorded: bile duct injury (95.7%), bile leak (95.7%), adhesional obstruction (15.2%), chest infection (6.5%), and death (2.2%). Following the introduction of the pre-printed form, all 23 forms achieved complete compliance (100%). Surgeons described the new form as time-saving, clear, comprehensive, and helpful in enhancing patient trust.

Conclusion: The introduction of a pre-printed consent form significantly transformed risk documentation for laparoscopic cholecystectomy, increasing from 0% to 100%. This simple, low-cost intervention standardises practice, strengthens medico-legal robustness, and supports shared decision-making. Wider adoption across surgical services may improve consent quality and patient safety.

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