An interventional study of Sublay Mesh Repair and Onlay Mesh Repair in Hernia, Ventral Hernia Repair and Incisional Hernia Repair, sponsored by Hayat Abad Medical Complex, Peshawar. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Hayat Abad Medical Complex, Peshawar · Not applicable, Interventional, and Treatment
This randomized controlled trial was conducted at the Department of Surgery, Hayatabad Medical Complex, Peshawar. Eligible patients with incisional hernia were randomized into two parallel groups: sublay mesh repair and onlay mesh repair. Procedures were performed by a single experienced general surgeon. Postoperative complications were assessed by an independent surgeon blinded to the type of procedure. Patients were followed for a period of three months to evaluate safety and recurrence outcomes.
Incisional hernia is a frequent postoperative complication following abdominal surgery and represents a significant source of morbidity due to discomfort, impaired quality of life, and risk of recurrence. Mesh reinforcement has become the standard approach for incisional hernia repair; however, the optimal anatomical position of mesh placement remains debated. Among the commonly used techniques, onlay mesh repair involves placement of mesh over the anterior rectus sheath, while sublay mesh repair places the mesh in the retromuscular preperitoneal plane. Each technique differs in operative dissection, tissue handling, and potential risk of postoperative complications.
This randomized controlled trial was conducted at the Department of Surgery, Hayatabad Medical Complex, Peshawar, to compare postoperative outcomes of onlay versus sublay mesh repair in patients undergoing elective incisional hernia repair. Adult patients aged 18 to 60 years presenting with incisional hernia and meeting predefined eligibility criteria were enrolled after providing written informed consent. Patients with recurrent, strangulated, or obstructed hernias, severe comorbid conditions, high anesthetic risk, or morbid obesity were excluded to minimize confounding factors.
Eligible participants were randomly allocated into two parallel groups using a lottery method. Patients assigned to Group A underwent sublay mesh repair, while those in Group B received onlay mesh repair. All surgical procedures were performed by a single experienced general surgeon to ensure procedural consistency. Standardized perioperative care protocols were followed for all patients.
Postoperatively, patients were monitored during hospital admission and followed in outpatient clinics for a period of three months. Assessment of postoperative complications, including wound infection, seroma, hematoma, and hernia recurrence, was carried out by an independent surgeon who was blinded to the surgical technique used. This masking approach was adopted to reduce assessment bias.
The primary objective of the study was to compare the overall postoperative complication rates between the two mesh placement techniques. Secondary objectives included evaluation of individual complication rates and recurrence during the follow-up period. Data were collected using a structured proforma and analyzed using standard statistical methods to determine differences between groups.
The findings of this study aim to provide evidence-based guidance regarding the safety and effectiveness of mesh placement techniques in incisional hernia repair and to assist surgeons in selecting an optimal approach that minimizes postoperative complications and recurrence.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's enrollment of 350 is above the median of 80 across 167 interventional studies indexed under Hernia.
Browse Hernia studies →Hayat Abad Medical Complex, Peshawar is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane.
Procedure: Sublay Mesh Repair
Patients underwent open incisional hernia repair with placement of polypropylene mesh over the anterior rectus sheath (onlay technique).
Procedure: Onlay Mesh Repair
Patients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane.
Placement of polypropylene mesh over the anterior rectus sheath during open incisional hernia repair.
Postoperative Complication Rate
Incidence of complications within 30 days after surgery, including wound infection, seroma, hematoma, and hernia recurrence, in patients undergoing onlay versus sublay mesh repair of incisional hernia.
Time frame: 30 days after surgery
Length of Hospital Stay
Duration of hospitalization following surgery in both study groups for this single disease.
Time frame: Number of days From enrollment up to the hospital discharge
Hernia Recurrence Rate
Number of patients with hernia recurrence within 6 months and 12 months postoperatively.
Time frame: Assessed at 6 months and 12 months after surgery
Operative Time
Total duration of surgery from incision to closure for onlay and sublay procedures.
Time frame: During the index surgical procedure (from skin incision to skin closure)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The decision to share individual participant data (IPD) from this study has not yet been finalized. Considerations regarding patient privacy, data de-identification, and institutional policies on data sharing are still under review. Once these factors are addressed, a detailed plan for data sharing may be developed in compliance with ethical guidelines and institutional requirements.
Ran from Aug 2020 to primary completion in Aug 2025, 60 months.
Of 50 non-industry interventional studies with no phase under Hernia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 64. This study's 60 months is above that.
Counting every sponsor, half of 57 studies reached it within 33 months; a quarter within 16 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Hayat Abad Medical Complex, Peshawar