Need for Subcutaneous Wound Drains in Ileostomy Reversal

NCT ID: NCT01050686

Last Updated: 2015-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Presence of Ileostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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subcutaneous wound drain

subcutaneous wound drain inserted

Group Type ACTIVE_COMPARATOR

insertion of subcutaneous wound drain

Intervention Type PROCEDURE

after the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted

no subcutaneous wound drain

no subcutaneous wound drain inserted

Group Type EXPERIMENTAL

no insertion of subcutaneous wound drain

Intervention Type PROCEDURE

closure of abdominal wall and skin without insertion of subcutaneous wound drain

Interventions

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insertion of subcutaneous wound drain

after the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted

Intervention Type PROCEDURE

no insertion of subcutaneous wound drain

closure of abdominal wall and skin without insertion of subcutaneous wound drain

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* elective open reversal of an protective ileostomy

Exclusion Criteria

* age \< 18 years
* missing suitability to comprehend patient information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Johannes Lauscher

PD Dr. Johannes Lauscher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johannes C Lauscher, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité Campus Benjamin Franklin; Hindenburgdamm 30

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EA4/120/09

Identifier Type: -

Identifier Source: org_study_id

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