sIPOM vs pIPOM in Incisional Hernia Patients | Clinical Trial | StuddyBuddy@endsection
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Completed
NCT05712213
sIPOM vs pIPOM in Incisional Hernia Patients
Conditions: Incisional Hernia
Sex: All
Ages: 18 Years – 65 Years
Enrollment: 187
Sponsor: University of Campania "Luigi Vanvitelli"
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 herniasBody mass index (BMI) < 35 kg/m2Elective surgery settingClean wound field according to the Centre for Disease Control and Prevention (CDC) wound classification (Grade I)Exclusion Criteria:Incisional hernia <3 or >12 cmAbdominal aortic aneurysm disordersPregnancy or lactationPsychiatric illnessMultifocal hernia defectLife expectancy<2 yearsInflammatory bowel diseaseemergency setting
Source: ClinicalTrials.gov (NCT05712213). StuddyBuddy aggregates publicly available trial information.