Loop Ileostomy ClosurePhase 4ILEOCLOSENCT02226887
Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh
A Phase 4 study testing MESH, NO MESH and Post-operative Imaging in people with Loop Ileostomy Closure, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Design Prospective , randomized, parallel phase IV. Objectives Main objective Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is "closed " to rebuild the intestinal transit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loop Ileostomy Closure
- What is being tested?
- MESH, NO MESH and Post-operative Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Jun 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a loop ileostomy closure
Who cannot join
- Patients under 18
- Pregnancy and Lactation
- Patients allergic to polyglycolic / trimethylene carbonate
- Carrier of prosthetic mesh in the ostomy
- Patients presenting midline hernia.
- Patients affected by inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, 08035
Borja Villanueva, MD, +34 629801238, b.villanueva@hotmail.com
Borja Villanueva Figueredo, MD
About this study
Official title: "Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "
Design Prospective , randomized, parallel phase IV.
Objectives Main objective
- Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is "closed " to rebuild the intestinal transit. The effectiveness evaluation is done by tracking with scheduled patient visits for 12 months, assessing the physical examination the presence or absence of an incisional hernia and an abdominal tomography at the end of the 12 months .
Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .
Read the detailed description
Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.
- Conditions
- Loop Ileostomy Closure
- Being tested
- MESH, NO MESH, Post-operative Imaging, Pre-operative Imaging, Blood Test and C-reactive protein at 4th day
- Keywords
- Loop ileostomy, Eventration
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESHProcedure or surgery
Also called Mesh : GORE® BIO-A®
- Pre-operative : It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
- Surgical technique:
- Peristomal incision with electrocautery
- Release the handle of ileum
- Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
- Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
- We add the mesh between the edges of the defect during fascia closure.
- The skin is sutured "purse string" style.
- Post-Op
- Hospital discharge after verification of normal digestive transit.
NO MESHProcedure or surgery
Also called Protocol Ileostomy closure
- Pre-operative : It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
- Surgical technique:
- Peristomal incision with electrocautery
- Release the handle of ileum
- Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
- Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
- The skin is sutured "purse string" style.
Post-Op
- Hospital discharge after verification of normal digestive transit
Post-operative ImagingRadiation
Abdominal Tomography 1 year after ileostomy closure
Pre-operative ImagingRadiation
Contrast study is used to ensure the integrity of the distal anastomosis
Blood Test and C-reactive protein at 4th dayOther
All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.
| Study group | Role | What they receive |
|---|---|---|
| MESH | Experimental | Not described Receives: Procedure: MESH; Radiation: Post-operative Imaging; Radiation: Pre-operative Imaging; Other: Blood Test and C-reactive protein at 4th day |
| NO MESH | Active comparator | Not described Receives: Procedure: NO MESH; Radiation: Post-operative Imaging; Radiation: Pre-operative Imaging; Other: Blood Test and C-reactive protein at 4th day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eventration
Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.
Measured: 1 year
Secondary outcomes (13)
Occlusive problems
Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),....
- This is a Clinical measure supported by image if necessary
- All the morbidity problems are reported independently.
- 1 patient can suffer a prolonged ileus and Anastomotic stenosis and both will be reported.
Measured: 30 days after surgery
Iatrogenic problems
Damage to structures such as ureters, bowel loops artery / iliac vein ....
- This is a Surgical and Clinical measure supported by image if necessary.
- All the morbidity problems are reported independently.
Measured: 30 days after surgery
Impaired healing
Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...
- This is a Clinical measure always supported by image tests.
- All the morbidity problems are reported independently.
Measured: 30 days after surgery
Bleeding problems
Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....
- This is a Clinical measure supported by image if necessary.
- All the morbidity problems are reported independently.
- The amount of blood loss won't be specified
Measured: 30 days after surgery
Cardiac complications
acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema
- This is a Clinical measure supported by more specific tests if necessary.
- All the morbidity problems are reported independently.
- Cardiologist report will be required for including this items
Measured: 30 days after surgery
Nephro-urinary complications
Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...
- This is a Clinical measure supported by more specific tests if necessary.
- All the morbidity problems are reported independently.
Measured: 30 days after surgery
Respiratory complications
Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...
- This is a Clinical measure always supported by image .
- All the morbidity problems are reported independently.
Measured: 30 days after surgery
Vascular Complications
Deep venous thrombosis, phlebitis, thrombophlebitis, ...
- This is a Clinical measure supported by more specific test if necessary .
- All the morbidity problems are reported independently
Measured: 30 days after surgery
Gastrointestinal complications
Liver failure, gastrointestinal bleeding, severe malnutrition, ...
- This is a Clinical measure supported by blood test and further test if necessary
- All the morbidity problems are reported independently.
Measured: 30 days after surgery
Neurological complications
Disorientation, cerebral vascular accident, ...
- This is a Clinical measure.
- All the morbidity problems are reported independently.
- Neurologist report will be required beyond disorientation.
Measured: 30 days after surgery
Local infection
Superficial, deep, body-cavity
- This is a Clinical measure supported by image if necessary
- All the morbidity problems are reported independently
Measured: 30 days after surgery
Local complications
Hematoma, seroma, evisceration
- This is a Clinical measure
- All the morbidity problems are reported independently
Measured: 30 days after surgery
Hospital stay
Hospital stay since surgery is done
Measured: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loop Ileostomy ClosureStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Borja Villanueva Figueredo, MD, Principal investigator, Hospital Universitari Vall d'Hebron Research InstituteFrancesc Vallribera Valls, MD,PhD, Study director, Hospital Universitari Vall d'Hebron Research InstituteManuel Lopez-Cano, MD, PhD, Study director, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226887
- Sponsor's protocol ID
- PR(AG)288/2013
- Acronym
- ILEOCLOSE
- Status last verified
- Apr 2017
- First submitted
- 18 Mar 2014
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "
- ClinicalTrials.gov ID
- NCT02226887
- Acronym / sponsor ID
- ILEOCLOSE / PR(AG)288/2013
- Conditions
- Loop Ileostomy Closure
- Keywords
- Loop ileostomy, Eventration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 27 Aug 2014 (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.
Design Prospective , randomized, parallel phase IV.
Objectives Main objective
- Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is "closed " to rebuild the intestinal transit. The effectiveness evaluation is done by tracking with scheduled patient visits for 12 months, assessing the physical examination the presence or absence of an incisional hernia and an abdominal tomography at the end of the 12 months .
Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .
Detailed description
Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MESH | Experimental | Procedure: MESH, Radiation: Post-operative Imaging, Radiation: Pre-operative Imaging, Other: Blood Test and C-reactive protein at 4th day |
| NO MESH | Active comparator | Procedure: NO MESH, Radiation: Post-operative Imaging, Radiation: Pre-operative Imaging, Other: Blood Test and C-reactive protein at 4th day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a loop ileostomy closure
Key exclusion criteria (6 listed)
- Patients under 18
- Pregnancy and Lactation
- Patients allergic to polyglycolic / trimethylene carbonate
- Carrier of prosthetic mesh in the ostomy
- Patients presenting midline hernia.
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 |
|---|---|---|
| MESHAlso: Mesh : GORE® BIO-A®1. Pre-operative : It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure . 2. Surgical technique: * Peristomal incision with electrocautery * Release the handle of ileum * Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election). * Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule. * We add the mesh between the edges of the defect during fascia closure. * The skin is sutured "purse string" style. 3. Post-Op * Hospital discharge after verification of normal digestive transit. | Procedure or surgery | MESH |
| NO MESHAlso: Protocol Ileostomy closure1. Pre-operative : It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure . 2. Surgical technique: * Peristomal incision with electrocautery * Release the handle of ileum * Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election). * Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule. * The skin is sutured "purse string" style. Post-Op - Hospital discharge after verification of normal digestive transit | Procedure or surgery | NO MESH |
| Post-operative ImagingAbdominal Tomography 1 year after ileostomy closure | Radiation | MESH, NO MESH |
| Pre-operative ImagingContrast study is used to ensure the integrity of the distal anastomosis | Radiation | MESH, NO MESH |
| Blood Test and C-reactive protein at 4th dayAll patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge. | Other | MESH, NO MESH |
Primary outcome
Eventration
Time frame: 1 year
Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.
13 secondary outcomes
Occlusive problems
Time frame: 30 days after surgery
Iatrogenic problems
Time frame: 30 days after surgery
Impaired healing
Time frame: 30 days after surgery
Bleeding problems
Time frame: 30 days after surgery
Cardiac complications
Time frame: 30 days after surgery
Nephro-urinary complications
Time frame: 30 days after surgery
Respiratory complications
Time frame: 30 days after surgery
Vascular Complications
Time frame: 30 days after surgery
Gastrointestinal complications
Time frame: 30 days after surgery
Neurological complications
Time frame: 30 days after surgery
Local infection
Time frame: 30 days after surgery
Local complications
Time frame: 30 days after surgery
Hospital stay
Time frame: Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Loop Ileostomy Closure
Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
RecruitingObservational study
Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Postoperative Ileus, Colorectal Cancer Control and Prevention
Active, not recruiting
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Rectum Cancer
Recruiting
Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
Rectal Neoplasm
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.
Borja Villanueva Figueredo, MD principal investigator
Hospital Universitari Vall d'Hebron Research Institute
Francesc Vallribera Valls, MD,PhD study director
Hospital Universitari Vall d'Hebron Research Institute
Manuel Lopez-Cano, MD, PhD study director
Hospital Universitari Vall d'Hebron Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MESH, NO MESH and Post-operative Imaging in people with Loop Ileostomy Closure, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 1 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 13 Apr 2017. 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 Spain. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eventration (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2017.