Comparison of Sublay Versus Onlay Mesh Repair for Ventral Abdominal Wall Hernia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Incidence of surgical wound infection
研究概览
简要总结
This study is designed to compare two different surgical methods for repairing ventral abdominal wall hernias: sublay mesh repair and onlay mesh repair. Ventral hernias are common and occur when tissue pushes through a weak spot in the abdominal wall. Both sublay and onlay techniques involve placing a synthetic mesh to strengthen the abdominal wall, but the position of the mesh differs. This trial will evaluate postoperative outcomes, including surgical wound infections, seroma (fluid buildup), and hernia recurrence, over a six-month follow-up period. The findings are expected to help inform surgical decision-making, particularly in resource-limited hospitals.
详细描述
This prospective, open-label, randomized controlled trial aims to compare outcomes between sublay and onlay mesh repair techniques in patients with ventral abdominal wall hernias. The study is being conducted at Recep Tayyip Erdogan Hospital, Muzaffargarh, Pakistan, from February 2022 to August 2023. A total of 96 patients aged 18-60 years with primary or incisional ventral hernias (defect size 40-100 mm) are included. Patients are randomized into two groups: Group A undergoes onlay mesh repair, and Group B undergoes sublay mesh repair. Both procedures involve placement of macroporous polypropylene mesh with appropriate overlap and standard fixation techniques.
Primary outcomes include wound infection (as per CDC criteria), seroma formation (confirmed by ultrasound), and hernia recurrence (clinically and via ultrasonography) at six-month follow-up. Secondary outcomes include operative time, postoperative pain (measured via visual analog scale), and hospital stay duration. Data analysis will be performed using SPSS v26.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open-label study with no masking.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years
- •Primary or incisional ventral abdominal wall hernia
- •Hernia defect size between 40-100 mm
- •Duration of hernia ≥6 months
- •Suitable for open mesh hernioplasty
- •Written informed consent provided
排除标准
- •Diabetes mellitus >5 years
- •Chronic liver disease
- •Obstructed or strangulated hernia
- •Immunocompromised status
- •Severe cardiopulmonary disease or contraindications to general anesthesia
- •Pregnant or lactating women
- •Inability to attend follow-up visits
结局指标
主要结局
Incidence of surgical wound infection
时间窗: Within 30 days after surgery
Wound infection was assessed based on CDC criteria: fever \>38°C, erythema, purulent discharge, or swelling at the surgical site. Evaluated daily during hospitalization and at 2-week follow-up.
Incidence of seroma formation
时间窗: Within 30 days postoperatively
Seroma defined as subcutaneous fluid accumulation confirmed by clinical exam and ultrasonography. Evaluated during follow-up visits.
Hernia recurrence rate
时间窗: 6-month follow-up
Recurrence assessed through physical examination and confirmed via ultrasonography at 6 months after surgery.
次要结局
- Mean operative time(Time in minutes from skin incision to skin closure, recorded intraoperatively.)
- Length of postoperative hospital stay(From the day of surgery until hospital discharge (average of 3-7 days).)
- Postoperative pain score(At 6 hours, 24 hours, and 48 hours after surgery, and then every 48 hours thereafter until hospital discharge)
研究者
Sana Ehsan ullah
Principal Investigator and Senior Registrar
Recep Tayyip Erdogan Hospital Pakistan