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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Polypropylene mesh is placed over the anterior rectus sheath and fixed with Prolene sutures after hernia sac reduction.
Polypropylene mesh placed in the retrorectus space and fixed with Prolene sutures after Rectus Sheath Dissection
Recep Tayyip Erdogan Hospital
Muzaffargarh, Punjab Province, Pakistan
Incidence of surgical wound infection
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.
Time frame: Within 30 days after surgery
Incidence of seroma formation
Seroma defined as subcutaneous fluid accumulation confirmed by clinical exam and ultrasonography. Evaluated during follow-up visits.
Time frame: Within 30 days postoperatively
Hernia recurrence rate
Recurrence assessed through physical examination and confirmed via ultrasonography at 6 months after surgery.
Time frame: 6-month follow-up
Mean operative time
During surgery
Time frame: Time in minutes from skin incision to skin closure, recorded intraoperatively.
Length of postoperative hospital stay
Number of days from surgery to discharge recorded for each participant.
Time frame: From the day of surgery until hospital discharge (average of 3-7 days).
Postoperative pain score
Pain evaluated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain) during inpatient stay.
Time frame: At 6 hours, 24 hours, and 48 hours after surgery, and then every 48 hours thereafter until hospital discharge
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