Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

Cholecystitis Clinical Trial

Official title:

An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370344
• Other study ID #: GANO-05-147M
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 30, 2006
• Last updated: April 23, 2015
• Start date: September 2006
• Est. completion date: November 2011

Study information

• Verified date: April 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.

Description:

Small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven superior to conventional open cholecystectomy. However, it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced. Today, some 25% of all gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and frail patients. Previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons´ different expertise with the two methods. These studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy, but hard data are scarce. The objective of the present trial is to randomize eligible patients to two groups of surgeons, well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. Surgeons in the minilaparotomy group will consider extension of the incision when necessary, and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated. The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.

Comparison: Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: November 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cholecystectomy is considered the best available treatment.

2. The patient understands trial information and is capable of making a decision after having received information.

3. The patient wants to undergo cholecystectomy and accepts participation in the trial.

Exclusion Criteria:

1. Age below 18 years.

2. The patient is unable to understand trial information.

3. Competence for both trial groups are lacking when a patient is randomized.

4. The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).

5. The indication of cholecystectomy is proven or suspected cancer of the gallbladder.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Diseases
• Gallstones

Intervention

Procedure:
• Laparoscopic cholecystectomy
Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
• Small-incision open cholecystectomy
Operation by experts in small-incision open cholecystectomy.

Locations

Country	Name	City	State
Sweden	Lycksele Hospital	Lycksele	Västerbotten
Sweden	Department of Surgery and Perioperative Sciences, Umeå University Hospital	Umeå	Västerbotten

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Norrlandstingens Regionförbund

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cinà CS, Walter SD, Haynes B, Schünemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. Review. — View Citation

Harju J, Juvonen P, Eskelinen M, Miettinen P, Pääkkönen M. Minilaparotomy cholecystectomy versus laparoscopic cholecystectomy: a randomized study with special reference to obesity. Surg Endosc. 2006 Apr;20(4):583-6. Epub 2006 Jan 25. — View Citation

Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD006231. Review. — View Citation

Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD006229. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life, postoperative pain, and health care costs.		Three, seven, eleven, and 30 postoperative days and one year after the operation.	No
Secondary	Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.		Thirty days and one year after the operation.	No