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Comparison of Sublay and Onlay Mesh Repair in Ventral Hernia

S

Sana Ehsan ullah

Status

Completed

Conditions

Incisional Hernia
Ventral Hernia

Treatments

Procedure: Sublay Mesh Repair
Procedure: Onlay Mesh Repair

Study type

Interventional

Funder types

Other

Identifiers

NCT07140471
IHHN_IRB_2023_05_026

Details and patient eligibility

About

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

96 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Onlay Mesh Repair
Active Comparator group
Description:
Participants underwent onlay mesh repair, where the polypropylene mesh was placed over the anterior rectus sheath after hernia reduction and defect closure.
Treatment:
Procedure: Onlay Mesh Repair
Sublay Mesh Repair
Experimental group
Description:
Participants underwent sublay mesh repair, where the polypropylene mesh was placed in the retrorectus space after posterior sheath dissection.
Treatment:
Procedure: Sublay Mesh Repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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