LACH-Trial: LAparoscopic Correction of Hernia (LACH)

February 17, 2009 updated by: Ziekenhuisgroep Twente

The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.

Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain.

The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One of the complications in laparoscopic incisional / ventral hernia repair is postoperative pain. Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of this postoperative pain. Fixation of the mesh might also influence other outcome parameters such as return to preoperative activities, costs and recurrence rate.

The study hypothesis is that there is no difference in postoperative pain when comparing three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia repair.

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almelo, Netherlands, 7600 SZ
        • Ziekenhuisgroep Twente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-acute incisional hernia of the abdominal wall or ventral hernia of the abdominal wall
  • Informed consent
  • Elective surgery

Exclusion Criteria:

  • < 18 years and > 80 years
  • Prednison > 15 mg/24hr, started more than 2 weeks prior to surgery
  • Chronical cough (severe COPD etc)
  • Ascites
  • Peritoneal dialysis
  • Current abdominal infection
  • Complete loss of abdominal domain due to hernia (diameter more than 10 cm?)
  • Re-laparoscopic correction of ventral hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator
fixation of mesh with a single crown of tacks and absorbable sutures
Procedure: laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.
Other Names:
  • Vicryl
  • DualMesh
  • Mersilene
  • ProTack
  • Suture Passer
Active Comparator: 1
fixation of mesh with a double crown of tacks and no sutures
Procedure: laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.
Other Names:
  • Vicryl
  • DualMesh
  • Mersilene
  • ProTack
  • Suture Passer
Active Comparator: 2
fixation of mesh with a single crown of tacks and non-absorbable sutures
Procedure: laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.
Other Names:
  • Vicryl
  • DualMesh
  • Mersilene
  • ProTack
  • Suture Passer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of postoperative pain
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: one year
one year
Overall satisfaction
Time Frame: one year
one year
Postoperative stay
Time Frame: one month
one month
Per- and postoperative morbidity
Time Frame: one month
one month
Recurrence
Time Frame: Three years
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziekenhuisgroep Twente

Investigators

  • Principal Investigator: Eelco B Wassenaar, MD, Ziekenhuisgroep Twente
  • Study Director: Srjdan Rakic, MD, PhD, Ziekenhuisgroep Twente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 2, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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