LACH-Trial: LAparoscopic Correction of Hernia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ventral Hernia, Incisional Hernia

Intervention / Treatment
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* Procedure: laparoscopic correction of hernia with mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0<br>fixation of mesh with a single crown of tacks and absorbable sutures | Procedure: laparoscopic correction of hernia with mesh<br>* Correction of hernia with mesh and fixation of mesh using one of the arms.<br>* Other names: Suture Passer;|
| Active Comparator: 1<br>fixation of mesh with a double crown of tacks and no sutures | Procedure: laparoscopic correction of hernia with mesh<br>* Correction of hernia with mesh and fixation of mesh using one of the arms.<br>* Other names: Suture Passer;|
| Active Comparator: 2<br>fixation of mesh with a single crown of tacks and non-absorbable sutures | Procedure: laparoscopic correction of hernia with mesh<br>* Correction of hernia with mesh and fixation of mesh using one of the arms.<br>* Other names: Suture Passer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of postoperative pain |  | one year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic correction, ventral and incisional hernia, mesh fixation, postoperative pain