NCT07245108

Brief Summary

This prospective clinical cohort study will include patients with gallstones and abdominal pain scheduled for surgery (laparoscopic cholecystectomy). Data on quality of life, abdominal pain, gallstone disease, and patient characteristics will be collected before surgery. The outcomes will be assessed three months following surgery and will primarily be determinants for resolution of pain. The aim is to make a prediction score that may aid clinicians and patients in decision making about surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jan 2024Apr 2027

Study Start

First participant enrolled

January 22, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

November 24, 2025

Status Verified

October 1, 2025

Enrollment Period

3.2 years

First QC Date

November 15, 2025

Last Update Submit

November 20, 2025

Conditions

GallstonesGallstone AttackUncomplicated CholelithiasisCholecystolithiasis

Keywords

Cohort studyProspective clinical studyCholecystectomyLaparoscopic cholecystectomyPain relief

Outcome Measures

Primary Outcomes (1)

  • Prediction model for resolution of pain

    To build and validate a prediction model for resolution of pain (VAS≤4) following laparoscopic cholecystectomy

    From baseline before surgery to follow-up at three months after surgery

Secondary Outcomes (1)

  • Changes in symptoms following surgery

    From baseline before surgery to follow-up at three months after surgery

Study Arms (1)

Patients with gallbladder stones and biliary pain that undergo laparoscopic cholecystectomy

Patients are included if they have gallbladder stones on abdominal ultrasound examination, abdominal pain expected to be due to gallstones by the clinician and scheduled for elective laparoscopic cholecystectomy. Patients with either a history including biliary interventions or complicated gallstone disease such as pancreatitis, cholecystitis or bile duct stones will be excluded.

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

A surgical removal of the gallbladder through laparoscopy

Patients with gallbladder stones and biliary pain that undergo laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will include patients referred to outpatient clinics either from primary care general practitioners or from a hospital department. Currently six hospitals are included from four out of five Danish health care regions.

You may qualify if:

  • Ultrasound examination with presence of gallstones and description of size, number and presence of stones in infundibulum or cystic duct
  • Abdominal symptoms believed to be caused by symptomatic uncomplicated gallstones
  • Indication and candidate for elective laparoscopic cholecystectomy
  • Above 18 years of age
  • Ability to give oral and written consent
  • Ability to understand, speak and read Danish
  • Ability to receive digital post

You may not qualify if:

  • History of complicated gallstone disease including acute cholecystitis, pancreatitis, common bile duct stones, or cholangitis
  • Previous sphincterotomy
  • Abnormal liver function test (ALAT/ASAT, alkaline phosphatase, bilirubin) without magnetic resonance cholangio-pancreatography or endoscopic ultrasound to rule out common bile duct pathology
  • Indication for urgent cholecystectomy
  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bispebjerg Hospital

Copenhagen, Bispebjerg, 2400, Denmark

RECRUITING

Aalborg Universitetshospital

Aalborg, 9000, Denmark

RECRUITING

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Nordsjællands Hospital Hillerød

Hillerød, 3400, Denmark

RECRUITING

Regionshospital Nordjylland Hjørring

Hjørring, 9800, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, 2650, Denmark

RECRUITING

Regionshospital Viborg

Viborg, 8800, Denmark

RECRUITING

Related Publications (4)

  • Latenstein CSS, Hannink G, van der Bilt JDW, Donkervoort SC, Eijsbouts QAJ, Heisterkamp J, Nieuwenhuijs VB, Schreinemakers JMJ, Wiering B, Boermeester MA, Drenth JPH, van Laarhoven CJHM, Dijkgraaf MGW, de Reuver PR; SECURE trial collaborators. A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery. JAMA Surg. 2021 Oct 1;156(10):e213706. doi: 10.1001/jamasurg.2021.3706. Epub 2021 Oct 13.

    PMID: 34379080BACKGROUND

  • Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJ. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-18. doi: 10.1007/s00464-012-2516-9. Epub 2012 Oct 6.

    PMID: 23052498BACKGROUND

  • Bray F, Balcaen T, Baro E, Gandon A, Ficheur G, Chazard E. Increased incidence of cholecystectomy related to gallbladder disease in France: Analysis of 807,307 cholecystectomy procedures over a period of seven years. J Visc Surg. 2019 Jun;156(3):209-215. doi: 10.1016/j.jviscsurg.2018.12.003. Epub 2018 Dec 18.

    PMID: 30573436BACKGROUND

  • Lunevicius R, Nzenwa IC, Mesri M. A nationwide analysis of gallbladder surgery in England between 2000 and 2019. Surgery. 2022 Feb;171(2):276-284. doi: 10.1016/j.surg.2021.10.025. Epub 2021 Nov 12.

    PMID: 34782153BACKGROUND

MeSH Terms

Conditions

GallstonesCholecystolithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Daniel Mønsted Shabanzadeh, DMSc, PhD, MD

    Dansk: Offentligt hospital (inkl. universitetshospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Mønsted Shabanzadeh, DMSc, PhD, MD

CONTACT

+45 48295796daniel.moensted.shabanzadeh.01@regionh.dk

Felix Alfred Graabæk, MD

CONTACT

feg@regsj.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 24, 2025

Study Start

January 22, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

November 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(7)