Incisional HerniaPhase 4ILEOMESHNCT02896686
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
A Phase 4 study testing Clinical Follow Up and Reinforcement with Light Polypropylene Mesh in people with Incisional Hernia, run by Hospital Universitari Joan XXIII de Tarragona..
Trial summary
The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Clinical Follow Up and Reinforcement with Light Polypropylene Mesh
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer.
- elective surgery for loop ileostomy closure
- ASA (American Society of Anesthesiologists)<4
Who cannot join
- allergy or intolerance to polypropilene
- patients with a prior mesh on the abdominal wall
- ASA ≥IV
- patients with a life expectancy of <12 months
- chronic renal failure in haemodialysis
- patients on steroid therapy
About this study
Official title: Multicentric, Prospective, Randomized and Simple Blind Study to Determine the Efficacy of the Placement of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure in Patients With a Prior Rectal Resection for Cancer
The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer
Read the detailed description
The primary aim of the study is to determine the efficacy of the placement of an onlay mesh for prevention of incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer. The efficacy will be evaluated by physical examination 3, 6 and 12 months after surgery and by abdominal CT scan one year after stoma closure.
Secondary aims are to evaluate the tolerability and safety of the prothesis; complications, quality of life and the need for further treatments will be compared between the groups.
This is a multicentric study that will include patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer. Elective surgery for loop ileostomy closure with ASA<4. Exclusion criteria include patients with allergy or intolerance to polypropilene, with a prior mesh on the abdominal wall, ASA ≥IV, patients with a life expectancy of <12 months, chronic renal failure in haemodialysis and patients on steroid therapy.
Patients that agree to participate in the study will be randomized using an electronic formula (Excel) of a uniformly distributed variable assigning case/control randomly until the total number of patients are included.
In the control group, after the digestive tract is reconstructed, the closure of the abdominal wall will be performed with a continuous suture of PDS loop 1/0 following Jenkins 4:1 rule and the skin will be closed using a subcutaneous purse-string closure. Patients in the study group will have the same procedure performed, and after the aponeurosis closure with PDS loop, an onlay light polypropilene mesh will be placed.
Each participant will have an assigned code depending on the participating Centre that will maintain anonymity at all times. All of the information will be registered in a database specifically designed for the study.
Statistical analysis will be performed by a descriptive study of the demographic variables and the incidence of incisional hernia after loop ileostomy closure. A comparative study between the groups will be performed using X2 test for categorical variables and t Student test or U-Mann for continuous variables. A binary logistic regression will also be performed to analyse the influence of each variable and to predict if the interventions produce incisional hernia.
- Conditions
- Incisional Hernia
- Being tested
- Control CT, Clinical Follow Up, Reinforcement with Light Polypropylene Mesh
- Keywords
- Ileostomy closure, Polypropylene Mesh, Incisional hernia
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control CTRadiation
At the end of the follow up (12 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the abdominal wall seen on the abdominal CT scan with the patient at rest.
The radiologist is blinded to the patient's history and the technique used for fascial closure.
Clinical Follow UpOther
The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
Reinforcement with Light Polypropylene MeshProcedure or surgery
Reinforcement with Light Polypropylene Mesh
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Abdominal wall closure will be done by continuous polydioxanone (PDS) suture following a SL:WL ratio of 4:1, and the skin will be closed using a subcutaneous purse-string closure Receives: Radiation: Control CT; Other: Clinical Follow Up |
| Reinforcement with Mesh | Experimental | Abdominal wall closure will be done by continous polydioxanone (PDS) suture following a SL:WL ratio of 4:1.
The incision is reinforced with onlay placement of a light polypropylene mesh (3 cm wide and the length corresponding to the incision), fixed to the aponeurosis with interrupted polyglactin (Vycril) suture.
The skin will be closed using a subcutaneous purse-string closure Receives: Radiation: Control CT; Other: Clinical Follow Up; Procedure: Reinforcement with Light Polypropylene Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia
The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 12 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).
Measured: 12 months
Secondary outcomes (2)
Perioperative complications
Secondary endpoints are perioperative complications, including wound infection, hematoma, pain and reoperation.
Measured: 30 days
Quality of life of the patients
The quality of life was evaluated by the SF-36 Quality of life test, during scheduled clinical visits over a period of 12 months.
Measured: 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Joan XXIII de Tarragona.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleidis Caro, Hospital Universitari Joan XXIII de Tarragona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896686
- Sponsor's protocol ID
- ILEOMESH
- Acronym
- ILEOMESH
- Status last verified
- Sep 2016
- First submitted
- 16 Apr 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Olona C, Caro-Tarrago A, Casanova R, Manas MJ, Ruiz C, Goncalves C, Sales R, Jorba R. Prevention of incisional hernia in ileostomy reversal. 5-year follow-up prospective randomized controlled trial. Hernia. 2025 Dec 12;30(1):29. doi: 10.1007/s10029-025-03531-4.
PubMed 41385147
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Prospective, Randomized and Simple Blind Study to Determine the Efficacy of the Placement of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure in Patients With a Prior Rectal Resection for Cancer
- ClinicalTrials.gov ID
- NCT02896686
- Acronym / sponsor ID
- ILEOMESH / ILEOMESH
- Conditions
- Incisional Hernia
- Keywords
- Ileostomy closure, Polypropylene Mesh, Incisional hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Hospital Universitari Joan XXIII de Tarragona.University, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- 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.
The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer
Detailed description
The primary aim of the study is to determine the efficacy of the placement of an onlay mesh for prevention of incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer. The efficacy will be evaluated by physical examination 3, 6 and 12 months after surgery and by abdominal CT scan one year after stoma closure.
Secondary aims are to evaluate the tolerability and safety of the prothesis; complications, quality of life and the need for further treatments will be compared between the groups.
This is a multicentric study that will include patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer. Elective surgery for loop ileostomy closure with ASA<4. Exclusion criteria include patients with allergy or intolerance to polypropilene, with a prior mesh on the abdominal wall, ASA ≥IV, patients with a life expectancy of <12 months, chronic renal failure in haemodialysis and patients on steroid therapy.
Patients that agree to participate in the study will be randomized using an electronic formula (Excel) of a uniformly distributed variable assigning case/control randomly until the total number of patients are included.
In the control group, after the digestive tract is reconstructed, the closure of the abdominal wall will be performed with a continuous suture of PDS loop 1/0 following Jenkins 4:1 rule and the skin will be closed using a subcutaneous purse-string closure. Patients in the study group will have the same procedure performed, and after the aponeurosis closure with PDS loop, an onlay light polypropilene mesh will be placed.
Each participant will have an assigned code depending on the participating Centre that will maintain anonymity at all times. All of the information will be registered in a database specifically designed for the study.
Statistical analysis will be performed by a descriptive study of the demographic variables and the incidence of incisional hernia after loop ileostomy closure. A comparative study between the groups will be performed using X2 test for categorical variables and t Student test or U-Mann for continuous variables. A binary logistic regression will also be performed to analyse the influence of each variable and to predict if the interventions produce incisional hernia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Radiation: Control CT, Other: Clinical Follow UpAbdominal wall closure will be done by continuous polydioxanone (PDS) suture following a SL:WL ratio of 4:1, and the skin will be closed using a subcutaneous purse-string closure |
| Reinforcement with Mesh | Experimental | Radiation: Control CT, Other: Clinical Follow Up, Procedure: Reinforcement with Light Polypropylene MeshAbdominal wall closure will be done by continous polydioxanone (PDS) suture following a SL:WL ratio of 4:1. The incision is reinforced with onlay placement of a light polypropylene mesh (3 cm wide and the length corresponding to the incision), fixed to the aponeurosis with interrupted polyglactin (Vycril) suture. The skin will be closed using a subcutaneous purse-string closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer.
- elective surgery for loop ileostomy closure
- ASA (American Society of Anesthesiologists)<4
Key exclusion criteria (6 listed)
- allergy or intolerance to polypropilene
- patients with a prior mesh on the abdominal wall
- ASA ≥IV
- patients with a life expectancy of <12 months
- chronic renal failure in haemodialysis
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 |
|---|---|---|
| Control CTAt the end of the follow up (12 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the abdominal wall seen on the abdominal CT scan with the patient at rest. The radiologist is blinded to the patient's history and the technique used for fascial closure. | Radiation | Control, Reinforcement with Mesh |
| Clinical Follow UpThe presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver. | Other | Control, Reinforcement with Mesh |
| Reinforcement with Light Polypropylene MeshReinforcement with Light Polypropylene Mesh | Procedure or surgery | Reinforcement with Mesh |
Primary outcome
Incidence of incisional hernia
Time frame: 12 months
The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 12 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).
2 secondary outcomes
Perioperative complications
Time frame: 30 days
Quality of life of the patients
Time frame: 3, 6 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Derived from this study: PubMed 41385147Olona C, Caro-Tarrago A, Casanova R, Manas MJ, Ruiz C, Goncalves C, Sales R, Jorba R. Prevention of incisional hernia in ileostomy reversal. 5-year follow-up prospective randomized controlled trial. Hernia. 2025 Dec 12;30(1):29. doi: 10.1007/s10029-025-03531-4.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinical Follow Up and Reinforcement with Light Polypropylene Mesh in people with Incisional Hernia, run by Hospital Universitari Joan XXIII de Tarragona..
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of incisional hernia (time frame: 12 months). 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 NCT02896686, which also lists 1 linked publication.
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 12 Sep 2016.