Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02542085
• Other study ID #: OuluUH
• Status: Active, not recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: September 4, 2015
• Start date: November 2012
• Est. completion date: August 2016

Study information

• Verified date: September 2015
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• Laparoscopic repair
operative method
• Hybrid repair
operative method

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Oulu University Hospital	Helsinki University Central Hospital, Kuopio University Hospital, Kymenlaakso Central Hospital Kotka Finland, Päijänne Tavastia Central Hospital, Seinajoki Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with seroma formation		1 month	Yes
Primary	number of patients with hernia recurrence		1 year	Yes
Secondary	number of patients with peri/postoperative complications	complications are reported perioperatively, during hospital stay, in 1 month control and in 1 year control	up to 1 year	Yes
Secondary	VAS pain scale	Pain scores (VAS) are measured during hospital day (average 3 days), in 1 month control and in 1 year control	1 year	Yes
Secondary	Quality of Life	patients are asked to fill SF/rand36-questionnaire preoperatively, in 1 month control and in 1 year control	preoperative-1month-1year	Yes