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

NCT07119203 | Recruiting

• 1 other identifier: 333268
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Robotic cholecystectomy; Laparoscopic cholecystectomy; Benign gallbladder disease; Randomized controlled trial; Cost-effectiveness

Outcome Measures

Primary Outcomes (4)

• Incidence (%) of postoperative complications within 30 days after surgery

  The incidence (%) of postoperative complications occurring within 30 days after surgery in patients with benign gallbladder disease. The outcome compares the total number of complications between patients treated with robotic cholecystectomy (RC) and those treated with laparoscopic cholecystectomy (LC).

  From day of surgery up to 30 days postoperatively

• Severity of postoperative complications within 30 days after surgery

  Complication severity will be graded using the Clavien-Dindo classification: 1. Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. 2. Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. 3. Requiring surgical, endoscopic or radiological intervention i. intervention not under general anaesthesia ii. intervention under general anaesthesia 4. Life-threatening complication (including central nervous system complications), requiring management in an Intensive Care Unit (ICU). 5. Death of a patient

  From day of surgery up to 30 days postoperatively

• Frequency (%) of postoperative complications within 30 days postoperatively

  The frequency (%) of individual postoperative complications occurring within 30 days following surgery in patients undergoing cholecystectomy.

  From day of surgery up to 30 days postoperatively

• Comprehensive Complication Index (CCI) score within 30 days after surgery

  The Comprehensive Complication Index (CCI) is a validated score based on the Clavien-Dindo classification system that quantifies all postoperative complications occurring within 30 days after surgery. The score ranges from 0 (no complications) to 100 (death), reflecting the cumulative burden of morbidity per patient.

  From day of surgery up to 30 days postoperatively

Secondary Outcomes (22)

• Duration of the procedure (minutes)

  Intraoperatively

• Peri-operative blood loss (millilitres)

  Intraoperatively

• Intra-abdominal pressure (mmHg) during surgery

  Intraoperatively

• Incidence (%) of gallbladder perforation during surgery

  Intraoperatively

• Incidence (%) of intraoperative complications

  Intraoperatively

Study Arms (2)

Robotic cholecystectomy

EXPERIMENTAL

Robotic multiport cholecystectomy

Procedure: Robotic cholecystectomy

Laparoscopic cholecystectomy

ACTIVE COMPARATOR

Conventional multiport laparoscopic cholecystectomy

Procedure: Laparoscopic cholecystectomy

Interventions

Robotic cholecystectomy PROCEDURE

Robotic multiport cholecystectomy

Robotic cholecystectomy

Laparoscopic cholecystectomy PROCEDURE

Conventional multiport laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or above 18 years;
• Benign gallbladder disease: diagnosis of gallbladder polyps or symptomatic gallstones proven on imaging (ultrasound, computed tomography (CT) scan or magnetic resonance cholangiopancreatography (MRCP));
• Capacity to give informed consent.

You may not qualify if:

• Minimally invasive procedure is not deemed possible by the operating surgeon;
• Evidence of acute cholecystitis;
• Known stones in the common bile duct (CBD);
• Suspicion of possible malignancy;
• Pregnancy;
• Diagnosis of liver cirrhosis (stage III or IV);
• Insufficient language skills to be able to perform the quality-of-life questionnaires.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

RECRUITING

Related Publications (2)

• Straatman J, Pucher PH, Knight BC, Carter NC, Glaysher MA, Mercer SJ, van Boxel GI. Systematic review: robot-assisted versus conventional laparoscopic multiport cholecystectomy. J Robot Surg. 2023 Oct;17(5):1967-1977. doi: 10.1007/s11701-023-01662-3. Epub 2023 Jul 13.

  PMID: 37439902 BACKGROUND

• Straatman J, Kooij CD, Mercer SJ, Pucher PH, Glaysher MA, Jenkins N, Tucker V, Carter NC, van Boxel GI. Surgical Techniques: Robotic versus conventional Laparoscopic cholecystectomy IN benign Gallbladder disease: a randomized controlled, open, parallel, non-inferiority, single-center trial (STaRLING trial). Trials. 2026 Feb 24. doi: 10.1186/s13063-026-09458-0. Online ahead of print.

  PMID: 41731509 DERIVED

Related Links

• Official trial website

MeSH Terms

Conditions

Gallstones

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Central Study Contacts

Gijsbert I. van Boxel

CONTACT

+44 023 9228 6000; g.vanboxel@nhs.net

Jennifer Straatman

CONTACT

j.straatman@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 13, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)