An interventional study of Robotic cholecystectomy and Laparoscopic cholecystectomy in Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic and Cholecystectomy, sponsored by Portsmouth Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Portsmouth Hospitals NHS Trust · Not applicable, Interventional, and Treatment
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.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 276 is above the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Robotic multiport cholecystectomy
Procedure: Robotic cholecystectomy
Conventional multiport laparoscopic cholecystectomy
Procedure: Laparoscopic cholecystectomy
Robotic multiport cholecystectomy
Conventional multiport laparoscopic cholecystectomy
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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From day of surgery up to 30 days postoperatively
Duration of the procedure (minutes)
Two time intervals will be recorded to assess procedure duration and robotic set-up times: Total time spent in the operating theatre, measured as the time from patient arrival (hh:mm) to exit (hh:mm). Actual surgical time, measured as the time from skin incision ("knife to skin") to skin closure (hh:mm). Times will be recorded in minutes.
Time frame: Intraoperatively
Peri-operative blood loss (millilitres)
Peri-operative blood loss will be measured quantitatively in millilitres. Additionally, the number of tonsil swabs used during the procedure will be recorded as a qualitative indicator of blood loss.
Time frame: Intraoperatively
Intra-abdominal pressure (mmHg) during surgery
Intra-abdominal pressure will be continuously measured in millimeters of mercury (mmHg) during insufflation throughout the surgical procedure.
Time frame: Intraoperatively
Incidence (%) of gallbladder perforation during surgery
The percentage (%) of surgical procedures in which perforation of the gallbladder occurs intraoperatively.
Time frame: Intraoperatively
Incidence (%) of intraoperative complications
Percentage (%) of patients experiencing any intraoperative complication during surgery.
Time frame: Intraoperatively
Technical difficulty of the procedure graded according to Nassar classification
Technical difficulty of the procedure is graded as per Nassar et al.: Grade 1: Gallbladder-floppy, non-adherent; Cystic pedicle-thin and clear; Adhesions-Simple up to the neck/Hartmann's pouch Grade 2: Gallbladder-Mucocele, Packed with stones; Cystic pedicle-Fat laden; Adhesions-Simple up to the body Grade 3: Gallbladder-Deep fossa, Acute cholecystitis, Contracted, Fibrosis, Hartmann's adherent to common bile duct (CBD), Impaction; Cystic pedicle-Abnormal anatomy or cystic duct-short, dilated or obscured; Adhesions-Dense up to fundus; Involving hepatic flexure or duodenum Grade 4: Gallbladder-Completely obscured, Empyema, Gangrene, Mass; Cystic pedicle-Impossible to clarify; Adhesions-Dense, fibrosis, wrapping the gallbladder, Duodenum or hepatic flexure difficult to separate
Time frame: Intraoperatively
Assessment of liver parenchyma during surgery
Intraoperative assessment of the liver parenchyma, classified into one of the following categories based on visual and tactile evaluation by the surgeon: normal, enlarged, steatotic, or cirrhotic.
Time frame: Intraoperatively
Proportion of procedures in which common bile duct (CBD) assessment was performed
Percentage (%) of surgical procedures during which imaging-based assessment of the common bile duct (CBD) was performed. Assessment is defined as the use of on-table cholangiogram (OTC) or intraoperative ultrasound (IOUSS) for visualization of the CBD.
Time frame: Intraoperatively
Proportion (%) of patients who underwent common bile duct (CBD) exploration
Among patients in whom gallstones were identified in the common bile duct (CBD) during intraoperative assessment, the percentage (%) of cases in which CBD exploration was performed.
Time frame: Intraoperatively
Use of peri-operative antibiotics
According to current guidelines, prophylactic antibiotics are not routinely indicated. Any deviations, including type, dose, and timing of antibiotics given during surgery, will be recorded
Time frame: Intraoperatively
Incidence (%) and number of drains placed during surgery
Documentation of whether one or more surgical drains were placed intraoperatively. In cases with multiple drains, the total number of drains placed will be recorded.
Time frame: Intraoperatively
Surgical perceived effort measured by Surgical Task Load Index (SURG TLX)
Surgical perceived effort during the procedure will be assessed using the Surgical Task Load Index (SURG TLX), a surgical-specific adaptation of the NASA-TLX. The index evaluates six dimensions-mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions-each rated on a 0 to 20 scale (0 = low, 20 = high). Scores will be collected from the operating surgeon immediately after the procedure.
Time frame: Intraoperatively
Analgesia required in the recovery period
Amount and type of analgesia administered to the patient in the post-anesthesia care unit (recovery room) from arrival until discharge from recovery. Data includes all analgesic medications given and their dosages.
Time frame: From arrival in recovery room until discharge from recovery
Opioids prescribed upon discharge
Documentation of whether opioids were prescribed at the time of hospital discharge, including type, dose, and quantity.
Time frame: At hospital discharge (day of discharge)
Frequency (%) of same-day discharge
Percentage (%) of patients discharged from the hospital on the same calendar day as their surgical procedure.
Time frame: From surgery until discharge on the same day
Time from theatre departure to stage 3 recovery (minutes)
Duration in minutes from the patient's departure from the operating theatre to arrival in stage 3 recovery.
Time frame: From theatre departure until arrival in stage 3 recovery
Readmission rate (%) within 30 days after surgery
Percentage (%) of patients who are readmitted to the hospital for any cause within 30 days following surgery.
Time frame: From day of surgery to 30 days postoperatively
Incidence (%) of interventions needed within 30 days after cholecystectomy
Percentage (%) of patients requiring any additional medical or surgical interventions within 30 days following cholecystectomy.
Time frame: From day of surgery to 30 days postoperatively
Health-related quality of life measured by EuroQol 5D-5L (EQ-5D-5L)
The EQ-5D-5L is a standardized patient-reported questionnaire measuring health-related quality of life. It consists of a descriptive system assessing five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-with five severity levels each, ranging from no problems to extreme problems. Additionally, it includes a Visual Analogue Scale (EQ VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), on which patients rate their overall health. Higher EQ-5D-5L index scores and EQ VAS scores indicate better health-related quality of life.
Time frame: At baseline (preoperative), on the day of hospital discharge, at 7 days postoperatively, and at 30 days postoperatively
Gallstone-specific quality of life measured by Otago Condition-Specific Questionnaire (O-CSQ)
The Otago Condition-Specific Questionnaire (O-CSQ) is a validated patient-reported questionnaire assessing gallstone-specific quality of life. It encompasses four domains: Physical Functioning (pain, dyspepsia, diet changes), Systemic Functioning (fatigue), Social Functioning (daily duties, leisure, relationships), and Emotional Functioning (mood). The O-CSQ consists of 12 items, each scored on a 5-point Likert scale (1 = no symptom burden, 5 = highest symptom burden). Higher total scores indicate a higher symptom burden and therefore poorer quality of life.
Time frame: At baseline (preoperative) and at 30 days postoperatively
Quality of recovery measured by Quality of Recovery 15 (QoR-15) questionnaire
The Quality of Recovery 15 (QoR-15) questionnaire assesses postoperative recovery across five dimensions: pain, physical comfort, physical independence, emotional status, and psychological support. It consists of 15 items rated on an 11-point scale from 0 to 10. The total QoR-15 score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Time frame: At hospital discharge, 7 days postoperatively, and 30 days postoperatively
Cost-effectiveness based on hospital costs within 30 days after surgery
To assess the impact of implementing robotic cholecystectomy (RC) on hospital costs, case data will be collected and compared between the RC and laparoscopic cholecystectomy (LC) groups. This includes operative costs, admission costs, and additional treatment costs (total healthcare utilization) from the index operation up to 30 days postoperatively.
Time frame: From day of surgery up to 30 days postoperatively
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Only IPD used in the results publication.
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Portsmouth Hospitals NHS Trust