Overview

This trial is active, not recruiting.

Condition incisional hernia
Treatment laparoscopic mesh repair
Sponsor Oulu University Hospital
Collaborator Helsinki University Central Hospital
Start date November 2012
End date August 2016
Trial size 160 participants
Trial identifier NCT02542085, OuluUH

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
patients who are randomized to have a laparoscopic mesh repair
laparoscopic mesh repair
operative method
(Active Comparator)
patients who are randomized to have a laparoscopic mesh repair and fascial closure
laparoscopic mesh repair
operative method

Primary Outcomes

Measure
number of patients with seroma formation
time frame: 1 month
number of patients with hernia recurrence
time frame: 1 year

Secondary Outcomes

Measure
number of patients with peri/postoperative complications
time frame: up to 1 year
VAS pain scale
time frame: 1 year
Quality of Life
time frame: preoperative-1month-1year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study
Principal investigator Mirella Ahonen-Siirtola, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Oulu University Hospital.