LACH-Trial: LAparoscopic Correction of Hernia

Ziekenhuisgroep Twente

Status: Completed

Conditions: Incisional Hernia; Ventral Hernia

Treatments: Procedure: laparoscopic correction of hernia with mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00537927

P05-28

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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215 participants in 3 patient groups

0

Active Comparator group

Description:

fixation of mesh with a single crown of tacks and absorbable sutures

Treatment:

Procedure: laparoscopic correction of hernia with mesh

1

Active Comparator group

Description:

fixation of mesh with a double crown of tacks and no sutures

Treatment:

Procedure: laparoscopic correction of hernia with mesh

2

Active Comparator group

Description:

fixation of mesh with a single crown of tacks and non-absorbable sutures

Treatment:

Procedure: laparoscopic correction of hernia with mesh