Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.

Zagazig University

Status: Completed

Conditions: Hernia

Treatments: Procedure: laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0; Procedure: aparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS; Procedure: laparoscopic (IPOM) hernioplasty without repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04137172

IR-17324-2

Details and patient eligibility

About

entral hernias are a major cause of functional impairment, abdominal pain, and bowel obstruction. The overall incidence of primary ventral hernia is estimated to be between 4 and 5 % in the literature, and ventral incisional hernia rates vary from 35 to 60 % within 5 years after laparotomy . After laparoscopy, this rate is estimated to decline from 0.5 to 15 % even after two decades, LVHR or open repair (OVHR) is still a matter of debate because of concerns about seroma formation, recurrence rate, and the intraperitoneal mesh position. . The laparoscopic technique for repairing ventral and incisional hernias is now well established. However, several issues related to LVHR, such as the high recurrence rate of hernias with large fascial defects and in extremely obese patients, are yet to be resolved. Additional problems include seroma formation. To solve these problems, laparoscopic fascial defect closure with IPOM reinforcement (IPOM-Plus) has been introduced in the past decade, and a few studies have reported satisfactory outcomes. Although detailed techniques for fascial defect closure and handling of the mesh have been published, standardized techniques are yet to be established.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 years undergoing surgery for primary or incisional ventral hernia
• defect whose major axis not exceeding 12cm.

Exclusion criteria

• Patients undergoing revision
• Emergency surgery.
• Parastomal hernias were not included.
• Patients not candidate for laparoscopy including cardiac and COPD patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 3 patient groups

group1

Experimental group

Description:

underwent laparoscopic IPOM hernioplasty without repair

Treatment:

Procedure: laparoscopic (IPOM) hernioplasty without repair

group2

Experimental group

Description:

underwent laparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS

Treatment:

Procedure: aparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS

group3

Experimental group

Description:

underwent laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0

Treatment:

Procedure: laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0