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Completed

NCT Number: NCT00478348

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

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.

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Key information

Conditions

Postoperative Complications Disease Attributes Hematoma Hemorrhage Hernia Infections Inflammation Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence Seroma

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Visceral Surgery, University Hospital Center

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prosthetic repair of abdominal incisional hernia

Procedure

Rives-Stoppa repair of incisional hernia

Primary outcomes

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

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
May 24, 2007
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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