Symptomatic gallstone disease Gallstones
Conditions
Interventions
Patients in the intervention arm of the RCT will receive, in addition to usual care, the opportunity to attend the Lifestyle Front Office following their surgical consultation. The lifestyle intervent
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients > 16 year,referred to the surgical outpatient clinic with;complaints of abdominal pain andultrasound proven gallstones and/or sludge (International Classification of Primary Care code D98.03),eligible for laparoscopic cholecystectomy,willing to receive referral to Lifestyle front Office;obtained written informed consent.
Exclusion criteria
Exclusion criteria: History of complicated cholelithiasis (i.e. choledocholithiasis, acute cholecystitis, biliary pancreatitis or cholangitis) since these types of patients are scheduled for elective cholecystectomy to prevent recurrence of complicated cholelithiasis rather than to prevent complaints of symptomatic cholecystolithiasis. And often have other associated risks;Indication for primary open cholecystectomy, including previous open major upper abdominal surgery;Active malignancy at the time of referral to surgical outpatient clinic (excluding skin malignancies: basal cell carcinoma and non-metastatic squamous cell carcinoma); Expected short life span of less than 12 months;Suffering from severe or life-threatening systemic diseases (American Society of Anesthesiologists. ASA score III (patient with severe systemic disease (e.g., morbid obesity, renal failure) or IV (patient with severe systemic disease that is a constant threat to life)Known cirrhosis of the liver;Current schizophrenia, memory deficiency, or any other cognitive disorder that predispose them to unreliable questionnaire responses; Insufficient knowledge of the Dutch language;Known pregnancy at time of referral to surgical outpatient clinic or surgery;Suspicion of gallbladder cancer;Participation in other (experimental) trials investigating pharmaceutical agents or strategies aimed at intervening with the natural disease course.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoints are: the proportion of surgeries (superiority) and patient-reported pain (non-inferiority) at 18 months follow-up in each arm of the trial. Pain is assessed with a Visual Analogue Scale (VAS) and will also be assessed at 6,12 and 18 months. Clinically relevant pain reduction is defined as a reduction of at least 4 points on the VAS pain score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are:Patient reported outcomes are assessed with questionnaires after informed consent and after 6, 12 and 18 months.Pain outcomes (Izbicki pain score and VAS score)Quality of life and changes (EQ5D-5L, Gall-Q)Biliairy colic (ROME III criteria for biliairy colic)Treatment satisfaction (NRS/Likert scale (0-10))Lifestyle related outcomesLifestyle intervention related outcomes long term compliance physical and mental healthdietary habitsCost-effectiveness (iMCQ) will be assessed at 18 months Clinical outcomes will be assessed after 12 and 18 months from the hospital patient records.Biliary complications: severe colic with hospitalization, cholecystitis, biliary pancreatitis, choledocholithiasis.Surgical complications: bile duct injury, bleeding, infection, abscess, incisional hernia. Surgical complications are classified according Clavien Dindo classification.Costs are evaluated over a period 18 months with the iMCQ (health care resource consumption) plus specific information from the hospital administrative | — |
Countries
Netherlands
Contacts
Public ContactL.F.R. Santwijk
Radboud Universitair Medisch Centrum
Outcome results
None listed