Comparison of Hybrid and Laparoscopic Incisional Hernia Repair
This trial is active, not recruiting.
|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|
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)
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
number of patients with seroma formation
time frame: 1 month
number of patients with hernia recurrence
time frame: 1 year
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
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
|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.|
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