Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01625247
NCT01625247UnknownPhase 3

Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis

Yonsei University1 site in 1 country162 target enrollmentStarted: June 1, 2009Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Enrollment
162
Locations
1
Primary Endpoint
frequency of postoperative complication occurrence
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Acute cholecystis
  • •Laparoscopic cholecystectomy
  • •KAROFSKY PERFORMANCE SCALE > 70
  • •No history of major operation

Exclusion Criteria

  • •NYHA class > 3
  • •Open cholecystectomy
  • •No- compliance
  • •Intraoperative injuries
  • •Inadequate hemostasis

Arms & Interventions

1 arm

Experimental

Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.

Intervention: Surgical drainage (Procedure)

2 arm

Active Comparator

Patients under LC. Allocation to sham drain,

Intervention: Surgical drainage (Procedure)

Outcomes

Primary Outcomes

frequency of postoperative complication occurrence

Time Frame: whinin 1 week and 8 weeks postoperatively

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Early or delayed laparoscopic cholecystectomy after endoscopic sphincterotomy for combined cholecystolithiasis. A prospective randomised trial.Combined cholecystolithiasisUrological and Genital DiseasesGallbladder stones, cholecystolithiasis
ISRCTN42981144St Antonius Hospital, Department of Surgery (The Netherlands)96
Completed
Not Applicable
Effects of Drainage in Laparoscopic CholecystectomyAcute CholecystitisEmpyema of GallbladderAbscess of Gallbladder
NCT02027402Seoul St. Mary's Hospital198
Completed
Not Applicable
aparoscopic radical cholecystectomy with lymph nodes dissection for gallbladder carcinomaT1b/T2 gallbladder carcinoma
JPRN-UMIN000013841Chiba Tokushukai Hospital11
Completed
Not Applicable
Drain After Elective Laparoscopic CholecystectomyCholelithiasis
NCT00986544University of Roma La Sapienza106
Withdrawn
Not Applicable
Laparoscopic Assisted Transvaginal CholecystecomyCholelithiasis
NCT04113590University of Texas Southwestern Medical Center