Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

Not Applicable

• Conditions: Incisional Hernia
• Interventions: Procedure: Laparoscopic repair; Procedure: Hybrid repair

• Registration Number: NCT02542085
• Lead Sponsor: Oulu University Hospital

Brief Summary

Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation).

Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka, Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).

Patients are randomized to operative groups (lap. vs hybrid).

Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score (VAS) are reported.

The primary end-points:

* clinically and/or radiologically detected seroma in 1 month control

* clinically and/or radiologically detected recurrent hernia in 1 year control

The secondary end-points:

* peri-and postoperative outcomes/ complications, morbidity, mortality

* duration of hospital stay

* pain scale (VAS)

* Quality of Life (SF/Rand36)

Detailed Description

Hypothesis: Using a hybrid method seroma formation and hernia recurrence can be diminished.

Patient exclusion criteria:

Age\< 18 y or \> 80 y ASA \>4 (the American Society of Anaesthesiologists' classification of Physical Health) BMI\> 40 A previous mesh repair of the hernia Hernia defect size \<2 or \>7 cm Emergency operation

Eligible patients are randomized into two operative groups (lap/hybrid). In the laparoscopic group the hernia defect is covered with a Parietex composite mesh (using minimum of 5 cm marginals, Securestrap fixation instrument and four lifting strings. In hybrid group the hernia sack is resected and fascial defect is sutured through a minilaparotomy incision. After this, a mesh repair is performed laparoscopically.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2015-08-31
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

-Patients with incisional hernia

Exclusion Criteria

• BMI >40
• ASA IV
• a Prior mesh repair
• Hernia defect size <2 or >7 cm
• Emergency operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic repair	Laparoscopic repair	patients who are randomized to have a laparoscopic mesh repair
hybrid repair	Hybrid repair	patients who are randomized to have a laparoscopic mesh repair and fascial closure

Primary Outcome Measures

Name	Time	Method
number of patients with seroma formation	1 month
number of patients with hernia recurrence	1 year

Secondary Outcome Measures

Name	Time	Method
VAS pain scale	1 year	Pain scores (VAS) are measured during hospital day (average 3 days), in 1 month control and in 1 year control
Quality of Life	preoperative-1month-1year	patients are asked to fill SF/rand36-questionnaire preoperatively, in 1 month control and in 1 year control
number of patients with peri/postoperative complications	up to 1 year	complications are reported perioperatively, during hospital stay, in 1 month control and in 1 year control