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LACH-Trial: LAparoscopic Correction of Hernia (LACH)

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ClinicalTrials.gov Identifier: NCT00537927
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Ziekenhuisgroep Twente

Brief Summary:

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 or disease Intervention/treatment Phase
Incisional Hernia Ventral Hernia Procedure: laparoscopic correction of hernia with mesh Not Applicable

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  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Study Start Date : August 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Assessment of postoperative pain [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: one year ]
  2. Overall satisfaction [ Time Frame: one year ]
  3. Postoperative stay [ Time Frame: one month ]
  4. Per- and postoperative morbidity [ Time Frame: one month ]
  5. Recurrence [ Time Frame: Three years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: January 2009

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

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes