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Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?

NCT ID: NCT00478348

Last Updated: 2017-11-17

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2017-11-10

Brief Summary

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The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.

Detailed Description

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Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.

Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.

Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.

In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.

The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.

Conditions

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Postoperative Complications Hernia

Keywords

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Postoperative Complications Drainage Infection Seroma Hematoma Recurrence Abdominal Wall Hernia Surgical Mesh

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Drain

Group Type OTHER

Prosthetic repair of abdominal incisional hernia

Intervention Type PROCEDURE

Rives-Stoppa repair of incisional hernia

No drain

Group Type OTHER

Prosthetic repair of abdominal incisional hernia

Intervention Type PROCEDURE

Rives-Stoppa repair of incisional hernia

Interventions

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Prosthetic repair of abdominal incisional hernia

Rives-Stoppa repair of incisional hernia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of midline abdominal wall incisional hernia
* Adults of 20 to 80 years old
* ASA I to III
* Inform consent signed by the patient and investigators

Exclusion Criteria

* Incisional hernia less than 2 cm
* Groin hernia
* Antibiotic treatment before and during hospital admission
* Emergency admission for strangulated incisional hernia
* Immunosuppressing treatment
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Nicolas DEMARTINES

professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Demartines, MD

Role: STUDY_CHAIR

Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

Locations

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Department of Visceral Surgery, University Hospital Center

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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Willemin M, Schaffer C, Kefleyesus A, Dayer A, Demartines N, Schafer M, Allemann P. Drain Versus No Drain in Open Mesh Repair for Incisional Hernia, Results of a Prospective Randomized Controlled Trial. World J Surg. 2023 Feb;47(2):461-468. doi: 10.1007/s00268-022-06725-4. Epub 2022 Dec 15.

Reference Type DERIVED
PMID: 36520177 (View on PubMed)

Other Identifiers

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DP-2007-CHV-UNIL

Identifier Type: -

Identifier Source: org_study_id