Drain After Elective Laparoscopic Cholecystectomy

February 18, 2012 updated by: Erasmo Spaziani, University of Roma La Sapienza

Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial

The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After laparoscopic gallbladder removal patients are randomized to have a suction drain positioned in the subhepatic space or to have a sham drain in the subhepatic space. The primary outcome measure will be the presence of subhepatic fluid collection at ultrasonographic examination on the first postoperative day. Secondary outcome measures will be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and morbidity

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Italy
    • Latina
      • Terracina, Latina, Italy, 04019
        • University of Rome "La Sapienza" - Polo Pontino

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective laparoscopic cholecystectomy

Exclusion Criteria:

  • acute cholecystitis, cholangitis, or pancreatitis
  • no contraindication for the laparoscopic
  • no other additional procedure

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Absence of drain
Procedure: no drain
drain positioned on the skin
Procedure: drain not positioned
Drain positioned in the abdominal wall
Active Comparator: Drain
drain positioned in the subhepatic space after laparoscopic cholecystectomy
Procedure: drain positioned
drain positioned in the subhepatic space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Subhepatic Collection at Ultrasonographic Examination
Time Frame: first postoperative day
An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.
first postoperative day

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Postoperative Complications
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

University of Roma La Sapienza

Investigators

  • Study Director: Erasmo Spaziani, PhD, University of Rome "La Sapienza"- Polo Pontino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

March 23, 2012

Last Update Submitted That Met QC Criteria

February 18, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pic63

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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