Incisional Hernia

16

Review clinical trials related to Incisional Hernia. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Risk Factors for Mesh Infection After Abdominal Wall Reconstruction

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.

Participants needed: 420
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Minia UniversityUpdated: Aug 18, 2026Locations: 1
Eligibility criteria

Adults aged ≥18 years. [+2]

Suture-only repair without mesh. [+5]

Status: Recruiting

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

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.

Participants needed: 180
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Minia UniversityUpdated: Aug 18, 2026Locations: 1
Eligibility criteria

Age 18 years or older. [+4]

Emergency or urgent operation (incarceration with strangulation, obstruction, or... [+8]

Status: Recruiting

GORE® ENFORM Biomaterial Product Study

A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.

Participants needed: 245
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: W.L.Gore & AssociatesUpdated: Jul 30, 2026Locations: 9
Eligibility criteria

At least 18 years old at the time of informed consent. Minimum age required by s... [+4]

Treated in another drug or medical device study within 1 year of study enrollmen... [+28]

Status: Recruiting

oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

This study investigates on the effect of two different operative techniques to treat large abdominal wall defects. The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR). The main questions it aims to answer are: length of stay after the operation rate of complications rate of recurrence and reoperations quality of life. Participants will: Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.

Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, Basel, SwitzerlandUpdated: Jul 24, 2026Locations: 3
Eligibility criteria

Patient age >18 years [+3]

precedent hernia treatment with mesh placement in the retromuscular space [+8]

Status: Recruiting

Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy

The goal of this clinical trial is to investigate Negative Pressure Wound Therapy (NPWT) in adults undergoing emergency laparotomy. The main question it aims to answer is: Does NPWT decrease wound complications? Researchers will compare it against regular dressings to see if NPWT is superior.

Participants needed: 720
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Uppsala UniversityUpdated: Jul 7, 2026Locations: 6
Eligibility criteria

≥18 years old [+3]

Not able to consent (e.g. dementia, impaired cognitive function, unconscious) [+6]

Status: Recruiting

AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery

Natural orifice specimen extraction (NOSE) is a minimally invasive colorectal surgical technique in which the surgical specimen is removed through a natural orifice, including transanal or transvaginal routes, thereby avoiding an abdominal extraction incision. Observational studies suggest that NOSE may reduce wound-related morbidity and improve postoperative recovery, but prospective multicenter data evaluating long-term outcomes remain limited. AP-NOSES is a prospective, multicenter observational registry evaluating clinical, patient-reported, and long-term wound outcomes following minimally invasive colorectal surgery with NOSE or transabdominal specimen extraction. The primary objective is to compare time to incisional hernia within 24 months between NOSE-eligible patients undergoing planned NOSE extraction and NOSE-eligible patients undergoing planned transabdominal extraction. Secondary objectives include evaluation of postoperative complications, extraction-related morbidity, bowel function, urinary and sexual function, oncologic outcomes, and long-term patient-reported and clinical outcomes across participating centers. This study does not alter routine clinical care. Surgical technique, perioperative management, and follow-up are performed according to local institutional practice.

Participants needed: 800
Trial details
Age: 21+Biological sex: AllType: ObservationalSponsor: Singapore General HospitalUpdated: May 29, 2026Locations: 1
Eligibility criteria

Age 21 years or older [+4]

Emergency colorectal surgery [+10]

Status: Recruiting

Suture Repair vs Mesh Repair for Incisional Hernia

The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. The main question it aims to answer are: • Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.

Participants needed: 154
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Clayton PetroUpdated: Jan 7, 2026Locations: 5
Eligibility criteria

Adults >18 years old. [+5]

Emergent cases [+6]

Status: Not yet recruiting

Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure

This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.

Participants needed: 156
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Lady Reading Hospital, PakistanUpdated: Dec 15, 2025Locations: 1
Eligibility criteria

Age: 18-70 years. [+4]

Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds. [+6]

Status: Recruiting

Does Preoperative Physical Activity Predict Postoperative Complications After Incisional Hernia Repair ?

Patients with abdominal wall incisional hernia often have numerous comorbidities, making management complex. To date, no study has described the relationship between preoperative physical activity and the occurrence of complications, particularly severe ones, after incisional hernia repair. The research hypothesis is that "patient fragility" related to physical inactivity and comorbidities is a poor prognostic factor for the occurrence of complications after incisional hernia repair and a source of more severe complications.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University Hospital, Strasbourg, FranceUpdated: Sep 25, 2025Locations: 1
Eligibility criteria

Adult (≥18 years old) [+3]

Status: Recruiting

Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair

The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are: * Does mesh reinforcement reduce the incidence of incisional hernias? * What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications. Participants will: * Undergo clinical follow-ups and abdominal ultrasounds to detect IH. * Complete quality-of-life questionnaires (EQ-5D and PROMIS).

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Hôpital FribourgeoisUpdated: Jun 3, 2025Locations: 1
Eligibility criteria

Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA... [+3]

Patients with incomplete or missing medical records, including preoperative, int... [+2]

Status: Recruiting

Surgery with Botulinum Toxin a for Incisional Hernia

After laparotomy, treating large incisional hernias (width \>= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width is a significant risk factor for repair failure and recurrence. High rates of severe postoperative morbidity, up to 50%, are reported, linked to dissection extent, increased muscular tension, and abdominal pressure. Reconstructing normal anatomy by bringing muscles together may be impossible, leading to the use of complex procedures like component separation techniques (CST), involving large aponeurotomy for muscle relaxation. Intramuscular injection of botulinum toxin A (BTA) induces reversible flaccid paralysis, with potential benefits in hernia closure, known as "chemical CST." Retrospective studies suggest reduced muscle retraction and facilitated closure without specific morbidity. Prehabilitation with BTA aims to reduce surgical morbidity compared to repair and CST. The prospective evaluation of BTA's clinical benefits, including reduced postoperative morbidity, pain, successful abdominal closure, and decreased IH recurrence risk, is lacking. A prospective randomized double-blind placebo-controlled trial is proposed to demonstrate BTA's efficacy. The hypothesis is that BTA injection before IH repair is more effective than a placebo in reducing postoperative morbimortality. Secondary expectations include a significant reduction in complete closure of the abdominal wall without CST.

Participants needed: 260
Trial details
Phase: Phase 3Age: 18-79Biological sex: AllType: InterventionalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Jan 22, 2025Locations: 1
Eligibility criteria

Patients between 18 and 79 years; [+6]

Other types of IH (lateral, groin, para-stomal, portsite); [+19]

Status: Recruiting

Prevention of Incisional Hernia After Renal Transplantation

Randomized clinical trial to determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by reduction in the incidence of incisional hernia at 2 years post-transplantation.

Participants needed: 160
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUpdated: Nov 22, 2024Locations: 1
Eligibility criteria

Candidate for first kidney transplant

Patient receiving a second or successive renal transplant.

Status: Recruiting

Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.

The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (\>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.

Participants needed: 148
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fernandez ZamoraUpdated: Oct 8, 2024Locations: 1
Eligibility criteria

Patients diagnosed with colorectal pathology requiring urgent surgical treatment... [+4]

Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classi... [+4]

Status: Recruiting

Trocar Site Incisional Hernia Prevention

Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery. Methods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months. An ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination. Relevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique. There are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.

Participants needed: 94
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: Hospital Universitari Joan XXIII de Tarragona.Updated: Oct 2, 2024Locations: 2
Eligibility criteria

Patients undergoing elective laparoscopic cholecystectomy, with or without an ex... [+1]

Allergy or intolerance to any of the mesh components [+5]

Status: Recruiting

Incisional heRnia dIgestion Sexuality

After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Surgery which consists both of reducing pain and correcting the functional limitation and aesthetic damage helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of patients. The resulting benefits on quality of life and reduction of chronic pain have been demonstrated by several studies. This study tends to better understand the functional and sexual prejudices linked to these parietal pathologies by passing questionnaires to the operated patients

Participants needed: 100
Trial details
Age: 18-79Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Sep 8, 2023Locations: 1
Eligibility criteria

Patients aged 18 to 79 [+4]

Emergency surgery [+4]

Status: Not yet recruiting

Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen

Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed. Hypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates. Aims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique. Design A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Skane University HospitalUpdated: Oct 5, 2022
Eligibility criteria

Patient declining participation [+4]