Outcomes in Primary Ventral Wall Hernia Repair Using Onlay Mesh Hernioplasty Compared With Sublay Mesh Hernioplasty: A Randomized Controlled Trial
Sponsor study identifier
interventional
76
1 country
1
Study Start
August 11, 2025
Actual (reported)Primary Completion
October 10, 2026
Actual (reported)Study Completion
October 15, 2026
Actual (reported)This randomized controlled trial will compare the surgical outcomes of onlay mesh hernioplasty versus sublay mesh hernioplasty in patients with primary ventral wall hernias. The study will assess postoperative pain, seroma formation, hematoma, wound infection, and hernia recurrence over a 6-month follow-up period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 11, 2025
Actual (reported)October 10, 2026
Actual (reported)October 15, 2026
Actual (reported)October 19, 2026
Actual (reported)October 26, 2026
Actual (reported)Postoperative Pain
Pain intensity will be measured using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain).
12 hours, 4 days. 2 weeks
Seroma Formation
Accumulation of clear, serous fluid at the surgical site will be confirmed by clinical examination or ultrasonography (anechoic/hypoechoic fluid collection).
Seroma will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Hematoma Formation
Accumulation of blood at the surgical site will be confirmed by clinical examination (bruising, tender swelling) or ultrasonography (complex fluid collection).
Hematoma will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Wound Infection
Microbial contamination at the surgical site will be characterized by signs of inflammation (hyperemic, painful, hot swelling) with or without purulent discharge, requiring intervention.
Wound infection will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Recurrence of Hernia
Participants will undergo open ventral hernia repair with mesh placed in the pre-muscular plane (on top of the rectus muscle and beneath the subcutaneous tissue) after tensionless fascial defect closure. The mesh will overlap the defect by 3-5 cm. A drain will be placed in the subcutaneous plane.
Participants will undergo open ventral hernia repair with mesh placed in the retro-muscular plane (between the rectus muscle and posterior rectus sheath) after dissection of the hernia sac. The mesh will overlap the defect by at least 5 cm. A drain will be positioned between the posterior rectus sheath and rectus muscle.
Procedure: Onlay Mesh Hernioplasty will be performed.
Procedure: Sublay Mesh Hernioplasty will be performed.
Provincial Headquarter Teaching Hospital, Gilgit.
Gilgit, Gilgit-Baltistan, 54000, Pakistan
76 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2026
First Posted
October 26, 2026
Study Start
August 11, 2025
Actual (reported)Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia
Return of the hernia at the surgical site will be confirmed through clinical and sonological findings.
6 months
Contact the study team to confirm eligibility.
Primary Completion
October 10, 2026
Actual (reported)Study Completion
October 15, 2026
Actual (reported)Last Updated
October 26, 2026
Record last verified: 2026-10
Individual participant data will not be shared. Data will be kept confidential by the principal investigator under institutional and ethical committee restrictions. The informed consent will not include provisions for external data sharing, and patient privacy will be protected given the small single-center sample. Only aggregate results will be published in a peer-reviewed journal. Data will be stored securely at PHQ Hospital Gilgit for five years.
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Source: ClinicalTrials.gov.
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