Clinical trial NCT02542085: Comparison of Hybrid and Laparoscopic Incisional Hernia Repair
Official title: Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia
Keywords: incisional hernia
laparoscopic repair
hybrid repair
seroma
recurrent hernia
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Kymenlaakso Central Hospital Kotka Finland
name: Päijät Häme Central Hospital
name: Seinajoki Central Hospital
name: Kuopio University Hospital
First posted: 2015-09-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of patients with seroma formation
timeFrame: 1 month
measure: number of patients with hernia recurrence
timeFrame: 1 year
Secondary outcomes:
measure: number of patients with peri/postoperative complications
timeFrame: up to 1 year
measure: VAS pain scale
timeFrame: 1 year
measure: Quality of Life
timeFrame: preoperative-1month-1year
Other outcomes:
Locations:
Study officials:
affiliation: Oulu University Hospital
name: Tero Rautio, MD, PhD
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital
name: Mirella Ahonen-Siirtola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.