3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)

Horsens Hospital

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Glubran; Device: Securestrap; Device: Protack; Procedure: laparoscopic ventral herniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01534780

KIR-001-HRH

Details and patient eligibility

About

Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.

Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.

Full description

see brief summary

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ventral hernia 2(1,5) < dia > 7 cm
• danish speaking
• of sound mind
• bmi < 35
• ASA 3 or less, no contra indication against laparoscopy

Exclusion criteria

• other size hernias,
• no danish,
• bmi > 35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

fixation with Protack

Experimental group

Treatment:

Procedure: laparoscopic ventral herniotomy

Device: Protack

fixation with Securestrap

Experimental group

Treatment:

Procedure: laparoscopic ventral herniotomy

Device: Securestrap

fixation with Glubran

Experimental group

Description:

surgery

Treatment:

Device: Glubran

Procedure: laparoscopic ventral herniotomy