Cholecystitis Clinical Trial
Official title:
An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
NCT02461147 -
Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
|
||
Completed |
NCT01937104 -
ONSD According to the Position During Laparoscopy
|
N/A | |
Completed |
NCT02264444 -
Establishing Visualization Grading Scale on LESS Cholecystectomy
|
N/A | |
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
|