sIPOM vs pIPOM in Incisional Hernia Patients

Completed

• Conditions: Incisional Hernia
• Interventions: Procedure: Standard intraperitoneal onlay mesh repair (sIPOM); Procedure: Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)

• Registration Number: NCT05712213
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sIPOM Group	Standard intraperitoneal onlay mesh repair (sIPOM)	Laparoscopic Incisional Hernia was performed without fascia closure (sIPOM)
pIPOM Group	Intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM)	Laparoscopic Incisional Hernia repair was performed with closure of fascia with non-absorbable suture (pIPOM)

Primary Outcome Measures

Name	Time	Method
Evaluation of the Mesh Bulging (MB) rate postoperatively in pIPOM Groups and sIPOM Group	36 months	Mesh Bulging (MB) as any clinically evident protrusion through the hernial defect and opens into the hernial sac causing swelling. It was as well clinically and ultrasonographically evaluated at outpatient visit. US evaluation was carried out by a radiologist with 15 years of gastrointestinal US experience. A RS85 (Samsung Madison Co Ltd., Seoul, Korea) ultrasound with a convex transducer (CA1-7A) was employed. In doubtful cases of MB, computerized tomography (CT) was performed. MB was diagnosed and recorded if clinical criteria and/or ultrasound criteria were fulfilled.
Evaluation of the Hernia Recurrence (HR) postoperatively in pIPOM Group and sIPOM Group	36 months	Hernia Recurrence (HR) in pIPOM and sIPOM, was clinically and ultrasonographically evaluated at outpatient visit. In details, HR was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. US evaluation was carried out by a radiologist with 15 years of gastrointestinal US experience. A RS85 (Samsung Madison Co Ltd., Seoul, Korea) ultrasound with a convex transducer (CA1-7A) was employed. The ultrasonic criteria of HR were a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Size and location of all ultrasound detected HR were registered, as well as any other patient's complaint. In doubtful cases of HR, computerized tomography (CT) was performed. HR was diagnosed and recorded if clinical criteria and/or ultrasound criteria were fulfilled.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the incidence of wound events in pIPOM Group and sIPOM Group	30 days	The classification of wound events was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention (CDC) wound classification (superficial, deep or organ space). Surgical site events were reported according to the Ventral Hernia Working Group definitions. Actions for wound events were categorized as follows: antibiotics only, bedside wound interventions, percutaneous maneuvers or surgical debridement.
The evaluation of Quality of Life - Gastrointestinal quality of life index (GIQLI) questionnaire in pIPOM Group and sIPOM Group	36 months	The Gastrointestinal Quality of Life Index (GIQLI) is a validated, 36-item, self-administered questionnaire that addresses 5 domains: upper gastrointestinal symptoms (12 items), lower gastrointestinal symptoms (7 items), physical status (7 items), psychological status (5 items), and social status (5 items). Each item is quoted from 0 to 4; scores range from 0 to 144, with higher scores indicating better function. Correct or incorrect allocation was then evaluated.