NCT00478348

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

10.4 years

First QC Date

May 22, 2007

Last Update Submit

November 14, 2017

Conditions

Postoperative ComplicationsHernia

Keywords

Postoperative ComplicationsDrainageInfectionSeromaHematomaRecurrenceAbdominal WallHerniaSurgical Mesh

Outcome Measures

Primary Outcomes (1)

  • Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.

    30 days

Study Arms (2)

Drain

OTHER
Procedure: Prosthetic repair of abdominal incisional hernia

No drain

OTHER
Procedure: Prosthetic repair of abdominal incisional hernia

Interventions

Prosthetic repair of abdominal incisional herniaPROCEDURE

Rives-Stoppa repair of incisional hernia

DrainNo drain

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Incisional hernia less than 2 cm
  • Groin hernia
  • Antibiotic treatment before and during hospital admission
  • Emergency admission for strangulated incisional hernia
  • Immunosuppressing treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery, University Hospital Center

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 36520177DERIVED

MeSH Terms

Conditions

Postoperative ComplicationsHerniaInfectionsSeromaHematomaRecurrence

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalInflammationHemorrhageDisease Attributes

Study Officials

  • Nicolas Demartines, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of surgery

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 24, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2017

Study Completion

November 10, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

CH(1)