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Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease

NCT07119203 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-12-23

No results posted yet for this study

Summary

This is a single-center, randomized controlled, parallel, non-inferiority trial. All adult patients with benign gallbladder disease with an indication for cholecystectomy will be assessed for eligibility and included after obtaining informed consent. A total of 276 patients will be randomized to undergo either robotic cholecystectomy (RC) or laparoscopic cholecystectomy (LC). The primary endpoint will be the incidence and severity of postoperative complications within 30 days after surgery. Secondary endpoints include perioperative outcomes, total health care utilization, health-related quality of life (HR-QoL) as assessed by patient-reported outcome measures, and cost-effectiveness. Follow-up assessments will be conducted at 7 and 30 days postoperatively.

This is the first randomized controlled trial designed to compare RC with LC in the treatment of benign gallbladder disease. The trial aims to evaluate the safety and non-inferiority of RC relative to LC, providing important evidence to guide the progress and adoption of robotic surgery in clinical practice.

Conditions

  • Cholecystectomy, Robotic
  • Cholecystectomy, Laparoscopic
  • Cholecystectomy
  • Gallstones
  • Benign Gallbladder Disease

Interventions

PROCEDURE

Robotic cholecystectomy

Robotic multiport cholecystectomy

PROCEDURE

Laparoscopic cholecystectomy

Conventional multiport laparoscopic cholecystectomy

Sponsors & Collaborators

  • Portsmouth Hospitals NHS Trust

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-12
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119203 on ClinicalTrials.gov