HerniaNCT07401446
Complication Rate of Onlay vs Sublay Mesh Repair in Incisional Hernia
A study testing Sublay Mesh Repair and Onlay Mesh Repair in people with Hernia and Ventral Hernia Repair, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hernia, Ventral Hernia Repair, Incisional Hernia Repair
- What is being tested?
- Sublay Mesh Repair and Onlay Mesh Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Patients diagnosed with primary incisional hernia on clinical examination.
- Hernia suitable for open surgical repair with mesh.
- Both male and female patients.
- Patients able and willing to provide written informed consent.
Who cannot join
- Obstructed or strangulated hernia on presentation.
- Recurrent incisional hernia.
- Patients with BMI > 40.
- Patients with debilitating chronic diseases, including:
- Chronic liver disease
- Chronic renal impairment
Show all 11Show fewer
- Chronic cardiac disease
- Chronic pulmonary disease
- Patients with American Society of Anesthesiologists (ASA) physical status ≥ 3.
- Patients unfit for general anesthesia.
- Patients unable or unwilling to follow up for postoperative assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Complication Rates of Onlay vs Sublay Mesh Repair of Incisional Hernia
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.
Read the detailed description
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.
- Conditions
- Hernia, Ventral Hernia Repair, Incisional Hernia Repair, Abdominal Wall Hernia, Synthetic Mesh
- Being tested
- Sublay Mesh Repair, Onlay Mesh Repair
- Keywords
- incisional Hernia, Mesh repair, Onlay Mesh repair, sublay Mesh Repair
- Medical subject headings
- Hernia, Hernia, Abdominal, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublay Mesh RepairProcedure or surgery
Patients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane.
Onlay Mesh RepairProcedure or surgery
Placement of polypropylene mesh over the anterior rectus sheath during open incisional hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Sublay Mesh Repair | Experimental | Patients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane. Receives: Procedure: Sublay Mesh Repair |
| Onlay Mesh Repair | Active comparator | Patients underwent open incisional hernia repair with placement of polypropylene mesh over the anterior rectus sheath (onlay technique). Receives: Procedure: Onlay Mesh Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after surgery
Secondary outcomes (3)
Length of Hospital Stay
Duration of hospitalization following surgery in both study groups for this single disease.
Measured: 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.
Measured: Assessed at 6 months and 12 months after surgery
Operative Time
Total duration of surgery from incision to closure for onlay and sublay procedures.
Measured: During the index surgical procedure (from skin incision to skin closure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Aug 2020
- Primary completion31 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel group randomized design in which eligible participants were randomly assigned to one of two intervention arms. One group underwent sublay mesh repair, and the other group underwent onlay mesh repair for incisional hernia. Participants received only the intervention assigned to their group, and outcomes were compared between the two groups over a three-month follow-up period.
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gohar Ali, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401446
- Sponsor's protocol ID
- HMC-QAD-F No. IREB-1221
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004 Oct;240(4):578-83; discussion 583-5. doi: 10.1097/01.sla.0000141193.08524.e7.
PubMed 15383785Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19. doi: 10.1186/s12893-017-0207-0.
PubMed 28222776Pereira C, Gururaj S. Onlay Versus Sublay Mesh Repair for Incisional Hernias: A Systematic Review. Cureus. 2023 Jan 24;15(1):e34156. doi: 10.7759/cureus.34156. eCollection 2023 Jan.
PubMed 36713818Kohler A, Beldi G. [Recurrence after hernia surgery: complication or natural course?]. Chirurg. 2014 Feb;85(2):112-6. doi: 10.1007/s00104-013-2593-x. German.
PubMed 24435830Rayman S, Gorgov E, Assaf D, Carmeli I, Nevo N, Rachmuth J, Mnouskin Y. Quality of life, post-operative complications, and hernia recurrence following enhanced-view Totally Extra-Peritoneal (eTEP) Rives-Stoppa for incisional and primary ventral hernia repair. Updates Surg. 2023 Oct;75(7):1971-1978. doi: 10.1007/s13304-023-01572-x. Epub 2023 Jun 28.
PubMed 37378814Omar I, Zaimis T, Townsend A, Ismaiel M, Wilson J, Magee C. Incisional Hernia: A Surgical Complication or Medical Disease? Cureus. 2023 Dec 15;15(12):e50568. doi: 10.7759/cureus.50568. eCollection 2023 Dec.
PubMed 38222215
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Complication Rates of Onlay vs Sublay Mesh Repair of Incisional Hernia
- ClinicalTrials.gov ID
- NCT07401446
- Acronym / sponsor ID
- HMC-QAD-F No. IREB-1221
- Conditions
- Hernia, Ventral Hernia Repair, Incisional Hernia Repair, Abdominal Wall Hernia, Synthetic Mesh
- Keywords
- incisional Hernia, Mesh repair, Onlay Mesh repair, sublay Mesh Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel group randomized design in which eligible participants were randomly assigned to one of two intervention arms. One group underwent sublay mesh repair, and the other group underwent onlay mesh repair for incisional hernia. Participants received only the intervention assigned to their group, and outcomes were compared between the two groups over a three-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Sublay Mesh Repair | Experimental | Procedure: Sublay Mesh RepairPatients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane. |
| Onlay Mesh Repair | Active comparator | Procedure: Onlay Mesh RepairPatients underwent open incisional hernia repair with placement of polypropylene mesh over the anterior rectus sheath (onlay technique). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-60 years.
- Patients diagnosed with primary incisional hernia on clinical examination.
- Hernia suitable for open surgical repair with mesh.
- Both male and female patients.
- Patients able and willing to provide written informed consent.
Key exclusion criteria (11 listed)
- Obstructed or strangulated hernia on presentation.
- Recurrent incisional hernia.
- Patients with BMI > 40.
- Patients with debilitating chronic diseases, including:
- Chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublay Mesh RepairPatients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane. | Procedure or surgery | Sublay Mesh Repair |
| Onlay Mesh RepairPlacement of polypropylene mesh over the anterior rectus sheath during open incisional hernia repair. | Procedure or surgery | Onlay Mesh Repair |
Primary outcome
Postoperative Complication Rate
Time frame: 30 days after surgery
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.
3 secondary outcomes
Length of Hospital Stay
Time frame: Number of days From enrollment up to the hospital discharge
Hernia Recurrence Rate
Time frame: Assessed at 6 months and 12 months after surgery
Operative Time
Time frame: During the index surgical procedure (from skin incision to skin closure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 15383785Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004 Oct;240(4):578-83; discussion 583-5. doi: 10.1097/01.sla.0000141193.08524.e7.
- Results publication: PubMed 28222776Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19. doi: 10.1186/s12893-017-0207-0.
- Results publication: PubMed 36713818Pereira C, Gururaj S. Onlay Versus Sublay Mesh Repair for Incisional Hernias: A Systematic Review. Cureus. 2023 Jan 24;15(1):e34156. doi: 10.7759/cureus.34156. eCollection 2023 Jan.
- Results publication: PubMed 24435830Kohler A, Beldi G. [Recurrence after hernia surgery: complication or natural course?]. Chirurg. 2014 Feb;85(2):112-6. doi: 10.1007/s00104-013-2593-x. German.
- Results publication: PubMed 37378814Rayman S, Gorgov E, Assaf D, Carmeli I, Nevo N, Rachmuth J, Mnouskin Y. Quality of life, post-operative complications, and hernia recurrence following enhanced-view Totally Extra-Peritoneal (eTEP) Rives-Stoppa for incisional and primary ventral hernia repair. Updates Surg. 2023 Oct;75(7):1971-1978. doi: 10.1007/s13304-023-01572-x. Epub 2023 Jun 28.
- Results publication: PubMed 38222215Omar I, Zaimis T, Townsend A, Ismaiel M, Wilson J, Magee C. Incisional Hernia: A Surgical Complication or Medical Disease? Cureus. 2023 Dec 15;15(12):e50568. doi: 10.7759/cureus.50568. eCollection 2023 Dec.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sublay Mesh Repair and Onlay Mesh Repair in people with Hernia and Ventral Hernia Repair, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complication Rate (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401446, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.