Clinical Trial: Comparison of Hybrid and Laparoscopic Incisional Hernia Repair
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study
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 Summary:
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.
Sponsor: Oulu University Hospital
Current Primary Outcome:
- number of patients with seroma formation [ Time Frame: 1 month ]
- number of patients with hernia recurrence [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- number of patients with peri/postoperative complications [ Time Frame: up to 1 year ]complications are reported perioperatively, during hospital stay, in 1 month control and in 1 year control
- VAS pain scale [ Time Frame: 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 [ Time Frame: preoperative-1month-1year ]patients are asked to fill SF/rand36-questionnaire preoperatively, in 1 month control and in 1 year control
Original Secondary Outcome: Same as current
Information By: Oulu University Hospital
Dates:
Date Received: August 31, 2015
Date Started: November 2012
Date Completion: August 2016
Last Updated: September 4, 2015
Last Verified: September 2015