An interventional study of Onlay Mesh Hernioplasty and Sublay Mesh Hernioplasty in Ventral Hernia Repair and Hernia Abdominal Wall, sponsored by Provincial Headquarter Teaching Hospital Gilgit. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Provincial Headquarter Teaching Hospital Gilgit · Not applicable, Interventional, and Treatment
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.
Ventral hernia repair is a common surgical procedure, and the use of prosthetic mesh has significantly reduced recurrence rates. However, the optimal plane for mesh placement-onlay (pre-muscular) versus sublay (retro-muscular)-will remain debated. Onlay repair will be simpler and faster to perform, while sublay repair will be considered technically more demanding but may offer better physiological outcomes.
This study will be conducted at PHQ Hospital Gilgit. A total of 76 patients (38 per group) with primary ventral hernias (defect size 3-10 cm) will be randomized using a blocked randomization technique. Group A will undergo onlay mesh hernioplasty, and Group B will undergo sublay mesh hernioplasty. The primary outcomes will include postoperative pain (Visual Analogue Scale), seroma, hematoma, and wound infection. The secondary outcome will be hernia recurrence at 6 months. Data will be analyzed using SPSS version 26.0.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's enrollment of 76 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Provincial Headquarter Teaching Hospital Gilgit is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Hernia, Ventral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Abdominal. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Procedure: Onlay Mesh Hernioplasty
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: Sublay Mesh Hernioplasty
Procedure: Onlay Mesh Hernioplasty will be performed.
Procedure: Sublay Mesh Hernioplasty will be performed.
Postoperative Pain
Pain intensity will be measured using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Wound infection will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Recurrence of Hernia
Return of the hernia at the surgical site will be confirmed through clinical and sonological findings.
Time frame: 6 months
Plan to share: No — 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Provincial Headquarter Teaching Hospital Gilgit