NCT02027402

Brief Summary

During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 3, 2014

Completed
Last Updated

December 3, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

December 30, 2013

Results QC Date

November 23, 2014

Last Update Submit

November 30, 2014

Conditions

Acute CholecystitisEmpyema of GallbladderAbscess of Gallbladder

Outcome Measures

Primary Outcomes (1)

  • Complication

    complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.

    2 weeks

Secondary Outcomes (3)

  • Operative Time

    1day

  • Postoperative Hospital Stay

    2weeks

  • Postoperative Pain Score

    6hr after operation - 24hr after operation - 48hr after operation

Study Arms (2)

Drain insertion

EXPERIMENTAL

Laparoscopic cholecystectomy with drain insertion is performed in this arm.

Procedure: Laparoscopic cholecystectomy with drain insertion

no drain insertion

NO INTERVENTION

In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain

Interventions

Laparoscopic cholecystectomy with drain insertionPROCEDURE

In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space

Drain insertion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • acutely inflamed gallbladder

You may not qualify if:

  • chronic cholecystitis
  • gallbladder polyp or gallbladder cancer
  • the patient who underwent reduced port surgery
  • the patient who underwent common bile duct exploration during the operation
  • the patient who underwent concurrent operation
  • the patient who had past history of upper abdominal surgery
  • the patient who had a immunodeficiency state
  • the case which had a suspicion of delayed bile leakage
  • the case which had a incomplete cystic duct ligation
  • the patient who underwent open conversion surgery during the operation
  • the patient who had a high risk of bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea

Location

Related Publications (1)

  • Kim EY, Lee SH, Lee JS, Yoon YC, Park SK, Choi HJ, Yoo DD, Hong TH. Is routine drain insertion after laparoscopic cholecystectomy for acute cholecystitis beneficial? A multicenter, prospective randomized controlled trial. J Hepatobiliary Pancreat Sci. 2015 Jul;22(7):551-7. doi: 10.1002/jhbp.244. Epub 2015 Apr 16.

    PMID: 25881915DERIVED

MeSH Terms

Conditions

Cholecystitis, AcuteCholecystitis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Results Point of Contact

Title
Teaho Hong
Organization
Seoul St Mary's hospital
gshth@catholic.ac.kr
821052065266

Study Officials

  • Taeho Hong

    SeoulSt.Mary's hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant proffesor

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 6, 2014

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

December 3, 2014

Results First Posted

December 3, 2014

Record last verified: 2014-11

Locations

KR(1)