An observational study in Incisional Hernia, Ventral Hernia and Parastomal Hernia, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Minia University · Observational
Abdominal wall reconstruction (AWR) with mesh is the standard repair for ventral, incisional, parastomal and complex abdominal wall defects, but mesh-related infection remains one of its most serious complications - prolonging hospital stay, often requiring reoperation or removal of the mesh, and increasing the risk of hernia recurrence. Reported infection rates vary widely, and the independent contribution of individual risk factors remains uncertain, in large part because much of the existing evidence comes from retrospective series with inconsistent outcome definitions.
This single-centre, prospective observational cohort study will enrol consecutive adults undergoing elective or urgent AWR with synthetic, biosynthetic or biological mesh at a tertiary referral hernia unit. Participants will be followed for 12 months on a fixed schedule (7-10 days, 30 days, 90 days, 6 months and 12 months). Using internationally accepted, prespecified definitions of mesh infection and surgical site occurrence, the study will collect up to 18 candidate patient, defect, operative and perioperative risk factors and analyse them by multivariable logistic regression to identify the independent predictors of mesh-related infection within 90 days of surgery.
Secondary aims are to describe the incidence, timing, microbiology and management (salvage versus explantation) of mesh infection; to report surgical site occurrences and reoperation; and to derive an exploratory risk-stratification model. The findings are intended to support preoperative risk assessment, targeted patient optimisation, informed mesh and technique selection, and shared decision-making. The study is designed and reported in accordance with the STROBE statement.
Design and setting. A prospective, single-centre observational cohort study conducted at a tertiary referral hernia and abdominal wall surgery unit (Department of Surgery, Faculty of Medicine, Minia University, Egypt). Consecutive eligible adults undergoing AWR with mesh are enrolled at the time of surgery and followed prospectively. No study-specific intervention is imposed; surgical and perioperative management follow routine unit practice, and exposures (candidate risk factors) are observed rather than assigned.
Study period. The study runs for 24 months in total, from 15 August 2026 to 15 August 2028. Consecutive enrolment takes place over the first 12 months (15 August 2026 - 15 August 2027); each participant is then followed for 12 months, so that the last enrolled participant completes follow-up at the end of month 24. The 90-day primary-outcome window closes for the final participant in November 2027.
Objectives. The primary objective is to identify the independent risk factors associated with mesh-related infection within 90 days of AWR. Secondary objectives are to estimate the cumulative incidence and timing of mesh infection; to characterise its microbiology and the proportion managed by mesh salvage versus partial or complete explantation; to describe surgical site occurrence (SSO) and SSO requiring procedural intervention (SSOPI); to derive an exploratory, prespecified risk-stratification model and assess its discrimination and calibration; and to evaluate the association of mesh infection with hernia recurrence and reoperation at 12 months.
Primary outcome. Mesh-related infection within 90 days, confirmed by at least one of: purulent drainage from a peri-mesh space in contact with the prosthesis; positive microbiological culture from peri-mesh fluid, explanted mesh or an image-guided/operative peri-mesh specimen; cross-sectional imaging (preferably contrast-enhanced CT) demonstrating a peri-mesh collection or abscess with clinical signs of infection; or the need for operative or percutaneous intervention directed at infected mesh. Superficial incisional infection without mesh involvement is recorded separately, and deep or organ/space infection is coded using CDC/NHSN criteria.
Candidate predictors. Up to 18 prespecified variables across four domains - patient (age, sex, BMI/obesity, active smoking, diabetes and HbA1c, serum albumin, ASA class, immunosuppression, COPD), defect (defect width by EHS grouping, recurrent hernia, loss of domain, CDC wound class, VHWG grade, stoma/parastomal defect), operative (mesh type and position, component separation including transversus abdominis release, operative time, concomitant bowel procedure, estimated blood loss, drain use) and perioperative (antibiotic-prophylaxis appropriateness, intraoperative normothermia and glycaemia, transfusion, early SSO).
Follow-up. Participants are reviewed at baseline/operation and at 7-10 days, 30 days, 90 days (primary outcome), 6 months and 12 months. Outcome events are adjudicated against the prespecified definitions by two investigators, with disagreements resolved by consensus.
Sample size and analysis. Target enrolment is 420 participants (≈380 evaluable after ≈10% attrition; ≈53 expected events), sized to support a stable multivariable logistic regression model (events-per-variable ≥10) and precise estimation of infection incidence. Candidate predictors are analysed by univariable tests and multivariable logistic regression with adjusted odds ratios and 95% confidence intervals; Firth penalised likelihood or LASSO is used where events are limited. Model discrimination (c-statistic) and calibration (Hosmer-Lemeshow test, calibration plot) are assessed with optimism-corrected internal validation by bootstrapping. Prespecified secondary and sensitivity analyses include time-to-event modelling and subgroup analyses by mesh type, mesh position and wound contamination class.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's planned enrollment of 420 is above the median of 150 across 75 observational studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Consecutive adults (≥18 years) undergoing elective or urgent abdominal wall reconstruction with synthetic, biosynthetic or biological mesh for a ventral, incisional, parastomal or complex abdominal wall defect at a single tertiary referral hernia and abdominal wall surgery unit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive adults (≥18 years) undergoing elective or urgent abdominal wall reconstruction with synthetic, biosynthetic or biological mesh for a ventral, incisional, parastomal or complex abdominal wall defect, enrolled at the time of surgery and followed prospectively for 12 months. No study-specific intervention is imposed; management follows routine unit practice.
Incidence of mesh-related infection within 90 days of abdominal wall reconstruction
Proportion of participants with mesh-related infection, defined as infection involving the implanted mesh confirmed by at least one of: purulent drainage from the wound or a peri-mesh space in contact with the prosthesis; positive microbiological culture from peri-mesh fluid, the explanted mesh, or an image-guided/operative peri-mesh specimen; cross-sectional imaging (preferably contrast-enhanced CT) demonstrating a peri-mesh collection or abscess with clinical signs of infection; or the need for operative or percutaneous intervention directed at infected mesh, including partial or complete explantation for infection.
Time frame: Within 90 days after surgery
Cumulative incidence and timing of mesh-related infection
Cumulative incidence of mesh-related infection over the full follow-up period, and the timing (days from surgery) of each confirmed event, summarised by time-to-event methods.
Time frame: Through 12 months after surgery
Microbiology of mesh-related infection
Distribution of causative micro-organisms isolated from peri-mesh specimens among participants with confirmed mesh infection
Time frame: Through 12 months after surgery
Management of mesh infection: salvage versus explantation
Proportion of confirmed mesh infections managed by successful mesh salvage (non-operative/conservative measures) versus partial or complete mesh explantation.
Time frame: Through 12 months after surgery
Incidence of surgical site occurrence (SSO)
Proportion of participants with any surgical site occurrence (seroma, haematoma, surgical site infection, wound dehiscence, skin/soft-tissue necrosis, or enterocutaneous fistula) per the Ventral Hernia Outcomes Collaboration definitions.
Time frame: 30 days, 90 days and 12 months after surgery
Incidence of SSO requiring procedural intervention (SSOPI)
Proportion of participants with any SSO requiring procedural intervention (bedside opening, percutaneous drainage, or reoperation).
Time frame: 30 days, 90 days and 12 months after surgery
Incidence of surgical site infection
Proportion of participants with superficial incisional, deep incisional, and organ/space surgical site infection
Time frame: 30 days after surgery
Incidence of hernia recurrence
Proportion of participants with clinically or radiologically confirmed hernia recurrence at the repair site.
Time frame: 12 months after surgery
Incidence of unplanned reoperation related to the index repair
Proportion of participants undergoing any unplanned return to theatre related to the index abdominal wall reconstruction.
Time frame: 12 months after surgery
Performance of the exploratory risk-stratification model
Discrimination (area under the ROC curve / c-statistic) and calibration (Hosmer-Lemeshow test and calibration plot, with optimism-corrected internal validation by bootstrapping) of the prespecified multivariable risk-stratification model for mesh-related infection.
Time frame: At completion of follow-up and analysis (up to 42 months)
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.