Comparison of Complication Rates of Onlay vs Sublay Mesh Repair of Incisional Hernia
Phase: NA
Conditions: Hernia, Ventral Hernia Repair, Incisional Hernia Repair, Abdominal Wall Hernia, Synthetic Mesh
Sponsor: Hayat Abad Medical Complex, Peshawar

Study Protocol 
Official Title: 
Comparison of Complication Rates of Onlay vs Sublay Mesh 
Repair of Incisional Hernia 
Brief Title: 
Complication Rate of Onlay vs Sublay Mesh Repair in Incisional Hernia 
ClinicalTrials.gov Identifier: 
NCT ID: Not Yet Assigned 
Organization’s Unique Protocol ID: 
HMC-QAD-F No. IREB-1221 
Study Type: 
Interventional Study (Randomized Controlled Trial) 
Study Design: 
Parallel Assignment, Open Label 
Sponsor: 
Hayatabad Medical Complex, Peshawar, Pakistan 
Responsible Party: 
Principal Investigator 
Principal Investigator: 
Dr. Gohar Ali 
Principal Investigator 
Department of Surgery 
Hayatabad Medical Complex, Peshawar, Pakistan 
Ethics Approval: 
Approved by Ethical Committee, Hayatabad Medical Complex, Peshawar 
Approval Number: HMC-QAD-F No. IREB-1221 
Study Start Date: 
01 August 2020 
Primary Completion Date: 
31 August 2025 
Study Completion Date: 
15 September 2025 

Study Design: Open-label, parallel group, randomized controlled trial 
Objective: 
To compare postoperative complication rates between onlay and sublay mesh repair in adult patients with 
incisional hernia. 
Study Population: 
• 
Inclusion Criteria: 
o 
Adults aged 18–60 years 
o 
Primary incisional hernia 
o 
Fit for open mesh repair 
o 
Able to provide informed consent 
• 
Exclusion Criteria: 
o 
Obstructed/strangulated hernia 
o 
Recurrent hernia 
o 
BMI > 40 
o 
ASA ≥ 3 or severe comorbidities 
o 
Unable/unwilling to follow up 
Sample Size: 350 
Randomization: 
• 
Randomized 1:1 to onlay or sublay repair 
• 
Computer-generated random sequence 
Interventions: 
• 
Experimental: Sublay Mesh Repair — mesh placed in retromuscular/preperitoneal plane 
• 
Active Comparator: Onlay Mesh Repair — mesh placed over anterior rectus sheath 
Primary Outcome: 
• 
Postoperative complication rate within 30 days (wound infection, seroma, hematoma, recurrence) 
Secondary Outcomes: 
• 
Hernia recurrence at 6 and 12 months 
• 
Length of hospital stay 
• 
Operative time 
Follow-up: 
• 
Clinical assessment on day 7, day 30, 6 months, and 12 months postoperatively 

Ethics: 
• 
Approved by Institutional Review Board, HMC (HMC-QAD-F No. IREB-1221) 
• 
Written informed consent obtained from all participants 
Data Management: 
• 
Data recorded in secured database and standardized proforma 
• 
Patient identifiers removed for any shared datasets. 
• 
SPSS V23. Is used for data entry.