Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

Oulu University Hospital

Status: Unknown

Conditions: Incisional Hernia

Treatments: Procedure: Hybrid repair; Procedure: Laparoscopic repair

Study type: Interventional

Funder types: Other

Identifiers

NCT02542085

OuluUH

Details and patient eligibility

About

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)

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

laparoscopic repair

Active Comparator group

Description:

patients who are randomized to have a laparoscopic mesh repair

Treatment:

Procedure: Laparoscopic repair

hybrid repair

Active Comparator group

Description:

patients who are randomized to have a laparoscopic mesh repair and fascial closure

Treatment:

Procedure: Hybrid repair