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Cholecystectomy, RoboticSTaRLINGNCT07119203

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

A study testing Robotic cholecystectomy and Laparoscopic cholecystectomy in people with Cholecystectomy, Robotic and Cholecystectomy, Laparoscopic, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Robotic cholecystectomy and Laparoscopic cholecystectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteUnited Kingdom
Study dates
12 Sep 2025to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gijsbert I. van Boxel contact

+44 023 9228 6000

g.vanboxel@nhs.net

Jennifer Straatman contact

j.straatman@nhs.net

United Kingdom1 site, 1 recruiting
  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

    Jennifer Straatman, +442392286000, j.straatman@nhs.net

    Cezanne Kooij, cezanne.kooij@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease: A Randomized Controlled, Open, Parallel, Non-inferiority, Single-center Trial (STaRLING Trial)

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.

Being tested
Robotic cholecystectomy, Laparoscopic cholecystectomy
Keywords
Robotic cholecystectomy, Laparoscopic cholecystectomy, Benign gallbladder disease, Randomized controlled trial, Cost-effectiveness
Medical subject headings
Gallstones

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic cholecystectomyProcedure or surgery

    Robotic multiport cholecystectomy

  • Laparoscopic cholecystectomyProcedure or surgery

    Conventional multiport laparoscopic cholecystectomy

Study groups in NCT07119203
Study groupRoleWhat they receive
Robotic cholecystectomyExperimentalRobotic multiport cholecystectomy
Receives: Procedure: Robotic cholecystectomy
Laparoscopic cholecystectomyActive comparatorConventional multiport laparoscopic cholecystectomy
Receives: Procedure: Laparoscopic cholecystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From day of surgery up to 30 days postoperatively

  2. 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

    Measured: From day of surgery up to 30 days postoperatively

  3. Frequency (%) of postoperative complications within 30 days postoperatively

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

    Measured: From day of surgery up to 30 days postoperatively

  4. 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.

    Measured: From day of surgery up to 30 days postoperatively

Secondary outcomes (22)
  1. 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.

    Measured: Intraoperatively

  2. 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.

    Measured: Intraoperatively

  3. Intra-abdominal pressure (mmHg) during surgery

    Intra-abdominal pressure will be continuously measured in millimeters of mercury (mmHg) during insufflation throughout the surgical procedure.

    Measured: Intraoperatively

  4. Incidence (%) of gallbladder perforation during surgery

    The percentage (%) of surgical procedures in which perforation of the gallbladder occurs intraoperatively.

    Measured: Intraoperatively

  5. Incidence (%) of intraoperative complications

    Percentage (%) of patients experiencing any intraoperative complication during surgery.

    Measured: Intraoperatively

  6. 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

    Measured: Intraoperatively

  7. 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.

    Measured: Intraoperatively

  8. 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.

    Measured: Intraoperatively

  9. 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.

    Measured: Intraoperatively

  10. 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

    Measured: Intraoperatively

  11. 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.

    Measured: Intraoperatively

  12. 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.

    Measured: Intraoperatively

  13. 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.

    Measured: From arrival in recovery room until discharge from recovery

  14. Opioids prescribed upon discharge

    Documentation of whether opioids were prescribed at the time of hospital discharge, including type, dose, and quantity.

    Measured: At hospital discharge (day of discharge)

  15. Frequency (%) of same-day discharge

    Percentage (%) of patients discharged from the hospital on the same calendar day as their surgical procedure.

    Measured: From surgery until discharge on the same day

  16. 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.

    Measured: From theatre departure until arrival in stage 3 recovery

  17. Readmission rate (%) within 30 days after surgery

    Percentage (%) of patients who are readmitted to the hospital for any cause within 30 days following surgery.

    Measured: From day of surgery to 30 days postoperatively

  18. Incidence (%) of interventions needed within 30 days after cholecystectomy

    Percentage (%) of patients requiring any additional medical or surgical interventions within 30 days following cholecystectomy.

    Measured: From day of surgery to 30 days postoperatively

  19. 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.

    Measured: At baseline (preoperative), on the day of hospital discharge, at 7 days postoperatively, and at 30 days postoperatively

  20. 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.

    Measured: At baseline (preoperative) and at 30 days postoperatively

  21. 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.

    Measured: At hospital discharge, 7 days postoperatively, and 30 days postoperatively

  22. 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.

    Measured: From day of surgery up to 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start12 Sep 2025
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07119203
Sponsor's protocol ID
333268
Acronym
STaRLING
Status last verified
Sep 2026
First submitted
14 Jul 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only IPD used in the results publication.

Publications

  • 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.

    PubMed 37439902
  • 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;27(1):254. doi: 10.1186/s13063-026-09458-0.

    PubMed 41731509

Questions about this trial

What is this clinical trial studying?

A study testing Robotic cholecystectomy and Laparoscopic cholecystectomy in people with Cholecystectomy, Robotic and Cholecystectomy, Laparoscopic, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gijsbert I. van Boxel (+44 023 9228 6000, g.vanboxel@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence (%) of postoperative complications within 30 days after surgery (time frame: From day of surgery up to 30 days postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07119203, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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