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)