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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.
Full description
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.
Enrollment
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Inclusion criteria
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
Exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
96 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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