NCT02542085

Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Incisional Hernia

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic repair	operative method
PROCEDURE	Hybrid repair	operative method

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-09-04
• Last updated: 2015-09-07