Need for Subcutaneous Wound Drains in Ileostomy Reversal

Not Applicable

Completed

• Conditions: Presence of Ileostomy
• Interventions: Procedure: insertion of subcutaneous wound drain; Procedure: no insertion of subcutaneous wound drain

• Registration Number: NCT01050686
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Study Start: 2010-03
• Primary Completion: 2014-11
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• elective open reversal of an protective ileostomy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subcutaneous wound drain	insertion of subcutaneous wound drain	subcutaneous wound drain inserted
no subcutaneous wound drain	no insertion of subcutaneous wound drain	no subcutaneous wound drain inserted

Primary Outcome Measures

Name	Time	Method
length of hospital stay (days)	3 months postoperatively

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité Campus Benjamin Franklin; Hindenburgdamm 30; 🇩🇪 Berlin, Germany