LACH-Trial: LAparoscopic Correction of Hernia

Not Applicable

Completed

• Conditions: Incisional Hernia; Ventral Hernia

• Registration Number: NCT00537927
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Primary Completion: 2008-10
• Status Verified: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of postoperative pain	one year

Secondary Outcome Measures

Name	Time	Method
Quality of life	one year
Overall satisfaction	one year
Postoperative stay	one month
Per- and postoperative morbidity	one month
Recurrence	Three years

Trial Locations

Locations (1)

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands