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

Not Applicable

Completed

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

• Registration Number: NCT04137172
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-03
• Primary Completion: 2019-08-30
• Study Completion: 2019-09-29
• Status Verified: 2019-10
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-23
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group3	laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0	underwent laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0
group1	laparoscopic (IPOM) hernioplasty without repair	underwent laparoscopic IPOM hernioplasty without repair
group2	aparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS	underwent laparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS

Primary Outcome Measures

Name	Time	Method
post operative complications	6 months	Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery

Secondary Outcome Measures

Name	Time	Method
Surgical Site Occurrence (SSO)	6 months to one year	Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam
Hernia Reoccurence	6 months to one year	A hernia that was repaired in the past but has returned
adequacy of different techniques	6 months to one year	Surgical Site Infection (SSI) CDC definition

Trial Locations

Locations (1)

Zagazig Unversity; 🇪🇬 Zagazig, Egypt