LACH-Trial: LAparoscopic Correction of Hernia

This study has been completed.
Sponsor:
Information provided by:
Ziekenhuisgroep Twente
ClinicalTrials.gov Identifier:
NCT00537927
First received: October 1, 2007
Last updated: February 17, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Incisional Hernia
Ventral Hernia
Procedure: laparoscopic correction of hernia with mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.

Resource links provided by NLM:


Further study details as provided by Ziekenhuisgroep Twente:

Primary Outcome Measures:
  • Assessment of postoperative pain [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Overall satisfaction [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Postoperative stay [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Per- and postoperative morbidity [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Recurrence [ Time Frame: Three years ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: August 2005
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0
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:
  • DualMesh
  • Mersilene
  • Vicryl
  • 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:
  • DualMesh
  • Mersilene
  • Vicryl
  • 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:
  • DualMesh
  • Mersilene
  • Vicryl
  • ProTack
  • Suture Passer

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537927

Locations
Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands, 7600 SZ
Sponsors and Collaborators
Ziekenhuisgroep Twente
Investigators
Principal Investigator: Eelco B Wassenaar, MD Ziekenhuisgroep Twente
Study Director: Srjdan Rakic, MD, PhD Ziekenhuisgroep Twente
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EB Wassenaar, MD, Ziekenhuisgroep Twente
ClinicalTrials.gov Identifier: NCT00537927     History of Changes
Other Study ID Numbers: P05-28
Study First Received: October 1, 2007
Last Updated: February 17, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Ziekenhuisgroep Twente:
laparoscopic correction
ventral and incisional hernia
mesh fixation
postoperative pain

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on October 02, 2014