Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: Laparoscopic repair
* Procedure: Hybrid repair


Participation Criteria
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Eligibility Criteria
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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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic repair<br>patients who are randomized to have a laparoscopic mesh repair | Procedure: Laparoscopic repair<br>* operative method<br>|
| Active Comparator: hybrid repair<br>patients who are randomized to have a laparoscopic mesh repair and fascial closure | Procedure: Hybrid repair<br>* operative method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with seroma formation |  | 1 month | 
| number of patients with hernia recurrence |  | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incisional hernia, laparoscopic repair, hybrid repair, seroma, recurrent hernia