Hernia Sac Flap Coverage of Mesh in Bony-Edged Ventral Hernia Repair

NCT07720154 | Not Yet Recruiting DMC

• 1 other identifier: 2058:7/2026
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This trial asks whether covering the inner, bowel-facing surface of a hernia mesh with a flap of the patient's own hernia sac improves healing after repair of a complex ventral (abdominal wall) hernia in which one edge of the defect is bone - for example hernias next to the breastbone and ribs, above the pubic bone, or at the iliac crest. In these "bony-edged" hernias the mesh is both hardest to fix and hardest to cover. There is no fascia on the bony side for the surgeon to stitch the mesh to, and the lining layer of the abdomen cannot be closed underneath the mesh because the plane that carries it stops at the bone. The mesh may therefore be left in contact with the bowel, which can lead to dense adhesions, mesh erosion, chronic pain and, rarely, a fistula. Normally the hernia sac - the thin membrane that lines the hernia - is cut away and discarded. In this trial the surgeon instead preserves it as a living, blood-supplied flap, rotates it underneath the mesh, and stitches it in place as a new lining layer that separates the mesh from the bowel and covers the bony edge. The technique uses only the patient's own tissue: no extra mesh, no donor site and no added cost. One hundred and eighty adults undergoing planned (non-emergency) open repair of a bony-edged complex ventral hernia will be randomly assigned in equal numbers to one of two groups: standard retromuscular (sublay) mesh repair with the added sac flap (90 participants), or standard retromuscular mesh repair alone, with the sac handled in the conventional way (90 participants). Every other step of the operation is the same in both groups. The main question is whether the sac flap reduces the number of participants who develop any wound or mesh problem in the first 30 days after surgery. This is measured as a composite called a surgical site occurrence, which includes wound infection, seroma, haematoma, skin or soft-tissue death, wound breakdown, mesh exposure and fistula. The trial also compares complications needing a drainage or operative procedure, hernia recurrence at 12 months, overall complication severity, operating time, blood loss, hospital stay, readmission, reoperation, pain, quality of life and death. Participants, ward and clinic staff, the doctors who assess the wounds, the radiologist who reads the follow-up scans and the trial statistician will not know which operation was performed; only the operating surgeon will. The group assignment is revealed only during the operation, after the surgeon has confirmed that the defect truly has a bony edge and that the sac is suitable for a flap. Participants are followed for 12 months.

Conditions

Incisional Hernia; Abdominal Hernia; Complex Ventral Hernia; Surgical Site Infection; Seroma; Postoperative Complications; Ventral Hernia

Keywords

ventral hernia; incisional hernia; complex abdominal wall reconstruction; bony-edged hernia; subxiphoid hernia; suprapubic hernia; lumbar hernia; iliac crest hernia; hernial sac; sac flap; peritonealization; neo-peritoneum; autologous tissue coverage; retromuscular mesh; sublay mesh repair; transversus abdominis release; posterior component separation; surgical site occurrence; mesh-visceral interface; mesh erosion; hernia recurrence

Outcome Measures

Primary Outcomes (1)

• Composite surgical site occurrence (SSO)

  Proportion of participants experiencing one or more components of the composite: surgical site infection (per CDC criteria), seroma, hematoma, skin or soft-tissue necrosis, wound dehiscence, mesh exposure, or enterocutaneous fistula. The outcome is binary (present/absent) at the participant level. It is assessed by independent masked outcome assessors using a structured wound proforma with photographic documentation; each component is also recorded individually, with its date of onset and management, so that components can be analyzed separately and so that the subset requiring procedural intervention can be derived.

  Within 30 days after surgery

Secondary Outcomes (13)

• Surgical site occurrence requiring procedural intervention (SSOPI)

  30 days and 90 days after surgery

• Hernia recurrence

  6 months and 12 months after surgery

• Overall morbidity: highest Clavien-Dindo grade

  30 days and 90 days after surgery

• Overall morbidity: Comprehensive Complication Index (CCI)

  30 days and 90 days after surgery

• Operative time

  Intra-operative (day of surgery, day 0)

Study Arms (2)

Sac-flap peritonealization + retromuscular mesh repair

EXPERIMENTAL

Participants undergo standard open retromuscular (sublay) synthetic mesh repair of the bony-edged complex ventral hernia, with posterior component separation by transversus abdominis release where required, PLUS peritonealization of the visceral surface of the mesh with a preserved, pedicled flap of the hernial sac. The sac is not excised. A broad flap is preserved on its vascular pedicle, rotated deep to the prosthesis before mesh fixation, and sutured circumferentially with a slow-absorbable suture to form a continuous autologous neo-peritoneal layer that fully separates the visceral surface of the mesh from the abdominal contents. At the bony margin, the leading edge of the flap is anchored across the bone to provide soft-tissue coverage and a fixation buttress. A closed-suction drain is placed in the retromuscular space.

Procedure: Sac-flap peritonealization of the mesh

Standard retromuscular mesh repair

ACTIVE COMPARATOR

Participants undergo standard open retromuscular (sublay) synthetic mesh repair of the bony-edged complex ventral hernia, with posterior component separation by transversus abdominis release where required, and conventional handling of the hernial sac: the sac is excised or simply reduced and is not used to cover the mesh. The visceral surface of the mesh is managed by the operating surgeon's standard practice - re-approximation of the posterior layer where feasible, or omental interposition - without an autologous sac neo-peritoneum and without sac-based coverage of the bony edge. Mesh type, fixation method, drainage and all perioperative care are identical to the experimental arm.

Procedure: Retromuscular (sublay) synthetic mesh repair

Interventions

Retromuscular (sublay) synthetic mesh repair PROCEDURE

Open repair through a midline or location-appropriate incision, with reduction of hernia contents and adhesiolysis as required; definition of the fascial defect including the bony margin, with measurement of defect width and length and recording of the European Hernia Society location and size class; development of the retromuscular (retrorectus) plane, with posterior component separation by transversus abdominis release where required to achieve tension-free closure; placement of a flat, medium-weight monofilament polypropylene mesh of standardized type in the retromuscular position with wide overlap and standardized suture fixation; anterior fascial closure of the linea alba where achievable; and closed-suction retromuscular drainage. This intervention is common to both arms and is delivered identically in each.

Also known as: Sublay mesh repair; Rives-Stoppa retromuscular repair; posterior component separation with transversus abdominis release where indicated

Standard retromuscular mesh repair

Sac-flap peritonealization of the mesh PROCEDURE

The hernial sac is not excised. After reduction of the hernia contents, a broad flap of the sac is preserved on its vascular pedicle. Before the mesh is fixed, the flap is rotated deep to the prosthesis and sutured circumferentially with a slow-absorbable suture to form a continuous neo-peritoneal layer that fully separates the visceral surface of the mesh from the abdominal contents. At the bony margin, the leading edge of the flap is anchored across the bone - to periosteum, to the contralateral posterior layer, or with trans-osseous or peri-osteal sutures as anatomy permits - providing soft-tissue coverage and a buttress where fascial fixation is impossible. Hemostasis of the flap is confirmed and a closed-suction drain is placed in the retromuscular space. No additional prosthetic material and no donor site are used.

Also known as: Pedicled hernial-sac flap; autologous neo-peritonealization; sac-flap neo-peritoneum

Sac-flap peritonealization + retromuscular mesh repair

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Elective open repair planned for a complex ventral hernia (primary or incisional) in which at least one margin of the fascial defect is formed by bone - that is, a subxiphoid or costal-margin, suprapubic, or iliac or lumbar location - confirmed on cross-sectional imaging (CT or MRI) and at operation.
• A hernial sac of sufficient quality and surface area to raise a pedicled flap adequate to cover the planned mesh, as judged at operation.
• Planned retromuscular (sublay) synthetic mesh repair, with or without posterior component separation (transversus abdominis release).
• Able to give written informed consent and to attend scheduled follow-up for 12 months.

You may not qualify if:

• Emergency or urgent operation (incarceration with strangulation, obstruction, or perforation).
• Active intra-abdominal infection, or a contaminated or dirty operative field (CDC wound class III-IV) at the time of randomization.
• Planned use of biologic or composite intraperitoneal mesh, or a bridged (non-fascial-closure) repair as the primary plan.
• Hernial sac absent, destroyed, densely scarred, or too small to raise a viable covering flap.
• Concurrent bowel resection or stoma creation expected to alter the wound-contamination class.
• ASA physical status V.
• Life expectancy less than 12 months, or active malignancy under treatment with anticipated short survival.
• Pregnancy.
• Inability or unwillingness to provide informed consent or to comply with follow-up

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University

Minya, Minya Governorate, 61519, Egypt

Location

Related Publications (10)

• Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.

  PMID: 19495920 BACKGROUND

• Slater NJ, Montgomery A, Berrevoet F, Carbonell AM, Chang A, Franklin M, Kercher KW, Lammers BJ, Parra-Davilla E, Roll S, Towfigh S, van Geffen E, Conze J, van Goor H. Criteria for definition of a complex abdominal wall hernia. Hernia. 2014 Feb;18(1):7-17. doi: 10.1007/s10029-013-1168-6. Epub 2013 Oct 23.

  PMID: 24150721 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.

  PMID: 23728278 BACKGROUND

• Kanters AE, Krpata DM, Blatnik JA, Novitsky YM, Rosen MJ. Modified hernia grading scale to stratify surgical site occurrence after open ventral hernia repairs. J Am Coll Surg. 2012 Dec;215(6):787-93. doi: 10.1016/j.jamcollsurg.2012.08.012. Epub 2012 Sep 19.

  PMID: 22999328 BACKGROUND

• Krpata DM, Schmotzer BJ, Flocke S, Jin J, Blatnik JA, Ermlich B, Novitsky YW, Rosen MJ. Design and initial implementation of HerQLes: a hernia-related quality-of-life survey to assess abdominal wall function. J Am Coll Surg. 2012 Nov;215(5):635-42. doi: 10.1016/j.jamcollsurg.2012.06.412. Epub 2012 Aug 4.

  PMID: 22867715 BACKGROUND

• Muysoms F, Campanelli G, Champault GG, DeBeaux AC, Dietz UA, Jeekel J, Klinge U, Kockerling F, Mandala V, Montgomery A, Morales Conde S, Puppe F, Simmermacher RK, Smietanski M, Miserez M. EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair. Hernia. 2012 Jun;16(3):239-50. doi: 10.1007/s10029-012-0912-7. Epub 2012 Apr 18.

  PMID: 22527930 BACKGROUND

• Novitsky YW, Elliott HL, Orenstein SB, Rosen MJ. Transversus abdominis muscle release: a novel approach to posterior component separation during complex abdominal wall reconstruction. Am J Surg. 2012 Nov;204(5):709-16. doi: 10.1016/j.amjsurg.2012.02.008. Epub 2012 May 16.

  PMID: 22607741 BACKGROUND

• Liang MK, Holihan JL, Itani K, Alawadi ZM, Gonzalez JR, Askenasy EP, Ballecer C, Chong HS, Goldblatt MI, Greenberg JA, Harvin JA, Keith JN, Martindale RG, Orenstein S, Richmond B, Roth JS, Szotek P, Towfigh S, Tsuda S, Vaziri K, Berger DH. Ventral Hernia Management: Expert Consensus Guided by Systematic Review. Ann Surg. 2017 Jan;265(1):80-89. doi: 10.1097/SLA.0000000000001701.

  PMID: 28009730 BACKGROUND

• Holihan JL, Nguyen DH, Nguyen MT, Mo J, Kao LS, Liang MK. Mesh Location in Open Ventral Hernia Repair: A Systematic Review and Network Meta-analysis. World J Surg. 2016 Jan;40(1):89-99. doi: 10.1007/s00268-015-3252-9.

  PMID: 26423675 BACKGROUND

MeSH Terms

Conditions

Incisional Hernia; Hernia, Abdominal; Surgical Wound Infection; Seroma; Postoperative Complications; Hernia, Ventral; Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Wound Infection; Infections; Inflammation

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operating surgeon cannot be masked, because the intervention is a surgical step. All other parties are masked: the participant; ward and clinic staff; the independent outcome assessors who perform the wound and recurrence evaluations; the radiologist who reads the follow-up imaging; and the trial statistician, who analyzes arms coded A and B. Operative notes that would reveal allocation are stored separately from the assessment record, and an identical dressing and drain regimen is used in both arms so that early wound appearance does not unmask assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery, Department of Surgery, Faculty of Medicine

Model Details: Single-center, parallel-group, two-arm, individually randomized superiority trial with 1:1 allocation. Randomization is stratified by hernia location (subxiphoid/costal vs suprapubic vs iliac/lumbar) and by defect width (\<10 cm vs \>=10 cm), using computer-generated variable permuted blocks with central concealed allocation. Allocation is revealed only intra-operatively, after the bony-edged defect and the adequacy of the hernial sac have been confirmed, so that the two arms differ only from the point of mesh placement.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)