Clinical Trials Logo
  1. Home
  2. Gallbladder Diseases
  3. NCT00370344

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 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00370344
Study type Interventional
Source Umeå University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 2006
Completion date November 2011
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03636841 - Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis N/A
Completed NCT02379780 - Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy N/A
Completed NCT01937104 - ONSD According to the Position During Laparoscopy N/A
Completed NCT02264444 - Establishing Visualization Grading Scale on LESS Cholecystectomy N/A
Completed NCT02461147 - Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00940264 - Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. N/A
Completed NCT00746850 - Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis N/A
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT02858986 - 3D Versus 4K Laparoscopic Cholecystectomy N/A
Completed NCT04602156 - US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy N/A
Completed NCT04942665 - Low Dose ICG for Biliary Tract and Tumor Imaging Phase 2
Completed NCT02547064 - Effect of Modified Stylet Angulation on the Intubation With GlideScope® N/A
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Completed NCT04122261 - A Clinical Study of Chinese Domestic Surgical Robot N/A
Completed NCT04716166 - Incentive Spirometry and Upper Abdominal Laparoscopic Surgery N/A
Completed NCT01476319 - Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department N/A
Withdrawn NCT02225418 - Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy N/A
Suspended NCT04306939 - Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
Completed NCT02782832 - No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery