NCT05712213

sIPOM vs pIPOM in Incisional Hernia Patients

Completed Last updated 6 February 2023

What this trial tests

trial testing Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM) in Incisional Hernia in 187 participants. Completed in 30 June 2022.

Timeline

1 January 2015

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Status	Completed
Study type	OBSERVATIONAL
Enrollment	187
Start date	1 January 2015
Primary completion	30 June 2022
Estimated completion	30 June 2022

Drugs / interventions tested

• Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)
• Standard intraperitoneal onlay mesh repair (sIPOM)

Conditions studied

• Incisional Hernia — all drugs for Incisional Hernia →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 65, any sex, with Incisional Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nowadays, two intraperitoneal mesh approaches are commonly used in Laparoscopic Ventral Hernia Repair (LVHR): the simple intraperitoneal onlay mesh repair (sIPOM) and the intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM). The pIPOM has been introduced to reduce adverse events in incisional hernia (IH) surgery (i.e., seroma formation, recurrences etc ) associated to laparoscopic hernia repair, and satisfactory outcomes has been reported in several studies. In details, sequelae such mesh bulging seems to be less associated to pIPOM than sIPOM, even if the latter topic is matter of intense debate. The pIPOM has been introduced in the guidelines for the laparoscopic treatment of ventral and incisional abdominal wall hernias published by the International Endohernia Society (IEHS) in 2014. Despite prospective studies on the quality of IPOM-Plus are available, the evidence level for the statements in these guidelines remains low. The aim of this prospective analysis is to compare the postoperative outcomes of patients treated for Incisional hernia (IH) with sIPOM and pIPOM after 36 months follow-up in terms of recurrence and wound events.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. IPOM plus versus IPOM standard in incisional hernia repair: results of a prospective multicenter trial.
   Pizza F, D'Antonio D, Lucido FS, Brusciano L, et al · · 2023 · cited 10× · PMID 37149818 · DOI 10.1007/s10029-023-02802-2