Incisional Hernia Clinical Trial
Official title:
Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study
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)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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