Medium Terms Outcome of sIPOM vs pIPOM in Patients Affected by Incisional Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 主要终点
- Evaluation of the Mesh Bulging (MB) rate postoperatively in pIPOM Groups and sIPOM Group
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Evaluation of the Mesh Bulging (MB) rate postoperatively in pIPOM Groups and sIPOM Group
时间窗: 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
时间窗: 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.
次要结局
- Evaluation of the incidence of wound events in pIPOM Group and sIPOM Group(30 days)
- The evaluation of Quality of Life - Gastrointestinal quality of life index (GIQLI) questionnaire in pIPOM Group and sIPOM Group(36 months)
研究者
Claudio Gambardella
Clinical Professor
University of Campania "Luigi Vanvitelli"