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

June 20, 2012 updated by: Yonsei University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dong Sup Yoon, MD
  • Phone Number: 82-2-2019-2444
  • Email: yds1660@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-720
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
        • Principal Investigator:
          • Dong Sup Yoon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 arm
Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.
Procedure: Surgical drainage
Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.
Active Comparator: 2 arm
Patients under LC. Allocation to sham drain,
Procedure: Surgical drainage
Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of postoperative complication occurrence
Time Frame: whinin 1 week and 8 weeks postoperatively
whinin 1 week and 8 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2008-0140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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