Need for Subcutaneous Wound Drains in Ileostomy Reversal (DRASTAR)

Charité University Medicine Berlin

Status: Completed

Conditions: Presence of Ileostomy

Treatments: Procedure: no insertion of subcutaneous wound drain; Procedure: insertion of subcutaneous wound drain

Study type: Interventional

Funder types: Other

Identifiers

NCT01050686

EA4/120/09

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective open reversal of an protective ileostomy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

subcutaneous wound drain

Active Comparator group

Description:

subcutaneous wound drain inserted

Treatment:

Procedure: insertion of subcutaneous wound drain

no subcutaneous wound drain

Experimental group

Description:

no subcutaneous wound drain inserted

Treatment:

Procedure: no insertion of subcutaneous wound drain