sIPOM vs pIPOM in Incisional Hernia Patients

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Incisional Hernia

Treatments: Procedure: Standard intraperitoneal onlay mesh repair (sIPOM); Procedure: Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)

Study type: Observational

Funder types: Other

Identifiers

NCT05712213

sIPOM vs pIPOM

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Incisional Hernia whit length >3 and <12 in width or length (Medium size according to European Hernia Society classification incisional hernias
• Body mass index (BMI) < 35 kg/m2
• Elective surgery setting
• Clean wound field according to the Centre for Disease Control and Prevention (CDC) wound classification (Grade I)

Exclusion criteria

• Incisional hernia <3 or >12 cm
• Abdominal aortic aneurysm disorders
• Pregnancy or lactation
• Psychiatric illness
• Multifocal hernia defect
• Life expectancy<2 years
• Inflammatory bowel disease
• emergency setting

Trial design

187 participants in 2 patient groups

pIPOM Group

Description:

Laparoscopic Incisional Hernia repair was performed with closure of fascia with non-absorbable suture (pIPOM)

Treatment:

Procedure: Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)

sIPOM Group

Description:

Laparoscopic Incisional Hernia was performed without fascia closure (sIPOM)

Treatment:

Procedure: Standard intraperitoneal onlay mesh repair (sIPOM)