Need for Subcutaneous Wound Drains in Ileostomy Reversal (DRASTAR)

February 11, 2015 updated by: Johannes Lauscher, Charite University, Berlin, Germany
The purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

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

  • Germany
      • Berlin, Germany, 12200
        • Charité Campus Benjamin Franklin; Hindenburgdamm 30

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective open reversal of an protective ileostomy

Exclusion Criteria:

  • age < 18 years
  • missing suitability to comprehend patient information

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
Active Comparator: subcutaneous wound drain
subcutaneous wound drain inserted
Procedure: insertion of subcutaneous wound drain
after the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted
Experimental: no subcutaneous wound drain
no subcutaneous wound drain inserted
Procedure: no insertion of subcutaneous wound drain
closure of abdominal wall and skin without insertion of subcutaneous wound drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of hospital stay (days)
Time Frame: 3 months postoperatively
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
surgical site infections
Time Frame: 3 months postoperatively
3 months postoperatively
colonization of abdominal wall with bacteria
Time Frame: 3 months postoperativly
3 months postoperativly
hematomas/ seromas
Time Frame: 3 months postoperatively
3 months postoperatively
postoperative complications
Time Frame: 3 months postoperatively
3 months postoperatively
postoperative pain/ dysaesthesia
Time Frame: 3 months postoperatively
3 months postoperatively
cosmetic result
Time Frame: 3 months postoperatively
3 months postoperatively
postoperative costs
Time Frame: 3 months postoperatively
3 months postoperatively

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Johannes C Lauscher, MD, Charite University, Berlin, Germany

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

March 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EA4/120/09

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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