The ProChol Study - Prospective Assessment of Symptoms Following Cholecystectomy in Patients With Symptomatic Uncomplicated Gallstones

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg Universitetshospital
RECRUITING
Aalborg
Bispebjerg Hospital
RECRUITING
Copenhagen
Herlev Hospital
RECRUITING
Herlev
Nordsjællands Hospital Hillerød
RECRUITING
Hillerød
Regionshospital Nordjylland Hjørring
RECRUITING
Hjørring
Hvidovre Hospital
RECRUITING
Hvidovre
Regionshospital Viborg
RECRUITING
Viborg
Contact Information
Primary
Daniel Mønsted Shabanzadeh, DMSc, PhD, MD
daniel.moensted.shabanzadeh.01@regionh.dk
+45 48295796
Backup
Felix Alfred Graabæk, MD
feg@regsj.dk
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2027-04
Participants
Target number of participants: 800
Treatments
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.
Sponsors
Collaborators: Copenhagen University Hospital Nordsjælland, Viborg Regional Hospital, University Hospital Bispebjerg and Frederiksberg, Zealand University Hospital, Copenhagen University Hospital at Herlev, Regionshospitalet Viborg, Skive, Aalborg University Hospital, Hvidovre University Hospital, Regionshospital Nordjylland
Leads: Nordsjaellands Hospital

This content was sourced from clinicaltrials.gov