Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

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)

Study Overview

• Status: Unknown
• Conditions: Incisional Hernia
• Intervention / Treatment: Procedure: Laparoscopic repair; Procedure: Hybrid repair

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laparoscopic repair; patients who are randomized to have a laparoscopic mesh repair	Procedure: Laparoscopic repair; operative method
Active Comparator: hybrid repair; patients who are randomized to have a laparoscopic mesh repair and fascial closure	Procedure: Hybrid repair; operative method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of patients with seroma formation	1 month
number of patients with hernia recurrence	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Quality of Life	patients are asked to fill SF/rand36-questionnaire preoperatively, in 1 month control and in 1 year control	preoperative-1month-1year

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Helsinki University Central Hospital; Kuopio University Hospital; Seinajoki Central Hospital; Päijät-Häme Central Hospital; Kymenlaakso Central Hospital Kotka Finland
• Investigators: Study Director: Tero Rautio, MD, PhD, Oulu University Hospital; Principal Investigator: Mirella Ahonen-Siirtola, MD, Oulu University Hospital

Publications and helpful links

General Publications

• Ahonen-Siirtola M, Nevala T, Vironen J, Kossi J, Pinta T, Niemelainen S, Keranen U, Ward J, Vento P, Karvonen J, Ohtonen P, Makela J, Rautio T. Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results. Surg Endosc. 2020 Jan;34(1):88-95. doi: 10.1007/s00464-019-06735-9. Epub 2019 Apr 2.
• Ahonen-Siirtola M, Nevala T, Vironen J, Kossi J, Pinta T, Niemelainen S, Keranen U, Ward J, Vento P, Karvonen J, Ohtonen P, Makela J, Rautio T. Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results. Hernia. 2018 Dec;22(6):1015-1022. doi: 10.1007/s10029-018-1784-2. Epub 2018 Jun 7.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: seroma; incisional hernia; laparoscopic repair; hybrid repair; recurrent hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: OuluUH