Clinical trial NCT05712213: sIPOM vs pIPOM in Incisional Hernia Patients
Official title: Medium Terms Outcome of sIPOM vs pIPOM in Patients Affected by Incisional Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referring to the Departments of General Surgery of 3 Tertiary Hospitals (the "A. Rizzoli" Hospital, in Lacco Ameno Naples, the University of Campania "Luigi Vanvitelli" of Naples and the AORN "A. Cardareli" of Naples) for Incisional Hernia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the Hernia Recurrence (HR) postoperatively in pIPOM Group and sIPOM Group
timeFrame: 36 months
measure: Evaluation of the Mesh Bulging (MB) rate postoperatively in pIPOM Groups and sIPOM Group
timeFrame: 36 months
Secondary outcomes:
measure: Evaluation of the incidence of wound events in pIPOM Group and sIPOM Group
timeFrame: 30 days
measure: The evaluation of Quality of Life - Gastrointestinal quality of life index (GIQLI) questionnaire in pIPOM Group and sIPOM Group
timeFrame: 36 months
Other outcomes:
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