Prophylactic Effect of a retromuscular mesh during Loop Ileostomy closure On incisional herNia incidence – a multicenter randomized patient- and observer-blind trial (P.E.L.I.O.N. Trial)
Organizational Data
- DRKS-ID:
- DRKS00027921
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-06-13
- Last update in DRKS:
- 2024-02-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
P.E.L.I.O.N
URL of the study
No Entry
Brief summary in lay language
Diverting loop ileostomy is used in colorectal surgery to reduce the consequences of leakage of a bowel anastomosis. According to the Department of Statistic of the Federal Republic of Germany approximately 15,000 diverting loop ileostomies and 11,500 loop ileostomy closures have been performed in 2015 in Germany. Up to one third of these cases are expected to develop an incisional hernia at the former stoma site, necessitating a hernia repair in 30-50% of these patients. An incisional hernia not only has an important negative impact on the patients’ quality of life (abdominal pain, discomfort and bowel disorders) and daily activity, but their repair also carries significant complication risk and represents an economic burden with an estimated annual cost of 8.2 million € for the German health care system. Few mostly retrospective studies indicate, that mesh reinforcement of the abdominal wall during ileostomy closure might significantly reduce the incidence of incisional hernia. However, no evidence from prospective randomized controlled trials (RCT) exists regarding this issue and mesh reinforcement of the abdominal wall during loop ileostomy closure is rarely used in daily practice nowadays. Evidence with this multicentric RCT is warranted to support or abandon the use of mesh reinforcement of the abdominal wall during loop ileostomy closure.
Brief summary in scientific language
The creation of a temporary protective ileostomy is used in colorectal surgery to reduce the consequences of intestinal anastomotic leakage after rectal resection. Within 2 years, up to a third of patients develop incisional hernias in the area of the former stoma and are therefore a frequent problem after ileostomy repositioning. These can lead to significant morbidity (e.g. pain, intestinal disorders), reduction in quality of life and daily activity, and even life-threatening complications such as intestinal entrapment. In addition, incisional hernias cause a significant burden on the health system and an estimated annual cost of €8.2 million for the German health system. The effectiveness of prophylactic mesh placement in reducing the frequency of incisional hernias in fascial closure in median laparotomies has already been confirmed. However, the current state of science is not yet sufficient for prophylactic mesh insertion in the event of stoma closure, as the studies carried out to date have shown deficiencies. The multi-centre, randomized, controlled P.E.L.I.O.N study investigates whether the insertion of an artificial mesh reduces the likelihood of incisional hernia during stoma retraction.
Health condition or problem studied
- ICD10:
- C20 - Malignant neoplasm of rectum
- ICD10:
- Z93.2 - Ileostomy status
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Abdominal wall closure during loop ileostomy closure with a continuous slowly absorbable suture reinforced with a retromuscular non-absorbable, macro-pore (pore size >/= 1000 μm or effective porosity >0%) light-weight monofilament or mixed structure mesh.
- Arm 2:
- Abdominal wall closure during loop ileostomy closure with a continuous slowly absorbable suture without mesh reinforcement.
Endpoints
- Primary outcome:
- Incisional hernia rate within 24 months after intervention as defined by the European Hernia Society
- Secondary outcome:
- 1. Postoperative complications within 30 days according to Dindo-Clavien classification (DCC) ≥ 3 • Number of Surgical Site Occurrences (SSO) defined as follows: 2. Superficial or deep surgical site infections (SSI) within 1 year after index operation according to the CDC definition. 3. Rate of wound seromas at former ostomy site within 30 days after index operation. 4. Rate of hematomas at former ostomy site within 30 days after index operation. 5. Enterocutaneous fistulas within 24 months after index operation. 6. Number of patients undergoing incisional hernia repair at site of ileostomy closure within 24 months after index operation. 7. Number of revision surgeries because of complication related to ileostomy closure within 24 months after index operation 8. Chronic postoperative pain in ileostomy closure site measured via the Pain Questions of the EHS-QoL questionnaire at baseline, 12 and 24 months postoperative. 9. Health-related Quality of Life at 12 and 24 months after index operation according to EHS -QoL questionnaire. 10. Hernia Recurrence Inventory (HRI) at 12 and 24 months.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Pius-Hospital Oldenburg Klinik für Allgemein- und Viszeralchirurgie Universitätsklinik für Viszeralchirurgie Oldenburg
- Medical center Bundeswehr Krankenhaus Ulm Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Ulm
- University medical center Zentrum Operative Medizin Chirurgisches Studienzentrum Klinik und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie Würzburg
- University medical center Universität Heidelberg Medizinische Fakultät Mannheim Chirurgische Klinik Mannheim
- Medical center GRN-Klinik Sinsheim Allgemein- und Viszeralchirurgie Sinsheim
- University medical center Universitätsklinik für Allgemeine, Viszeral- und Transplantationschirurgie Tübingen
- University medical center Klinikum der Universität München Klinik für Allgemein, Viszeral- und Transplantationschirurgie München
- University medical center Klinik und Poliklinik für Chirurgie Klinikum rechts der Isar der Technischen Universität München München
- University medical center Klinik für Allgemein- und Viszeralchirurgie Ulm
- University medical center Universitätsklinikum Freiburg Department Chirurgie Klinik für Allgemein- und Viszeralchirurgie Freiburg
- Medical center Asklepios Klinik Langen Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Langen
Recruitment period and number of participants
- Planned study start date:
- 2022-12-02
- Actual study start date:
- 2023-01-20
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 304
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1. Planned elective loop ileostomy closure 2. Adult Patients (≥ 18 years of age) 3. Life expectancy > 2 years 4. Written informed consent 5. Ability to understand character and individual consequences of the clinical trial
Exclusion Criteria
1. American Society of Anesthesiologists (ASA) physical status class >/= 4 2. Infected/septic surgical site (Risk for Surgical Site Occurrences (SSO) of Grade 4 according to Ventral Hernia Working Group (VHWG)-classification 3. Presence of parastomal hernia in loop ileostomy site with fascia defect > 8cm 4. Presence of a concomitant incisional hernia that impedes loop ileostomy reversal or placement of the mesh at the ileostomy site 5. Patients with prior mesh placement on site of ileostomy 6. Chronic renal failure under haemodialysis/ peritoneal dialysis 7. Patients under strong immunosuppression or other medications likely to impede wound healing as judged by the operating surgeon 8. Congenital haemorrhagic diathesis with need of perioperative treatment 9. Participation in another interventional trial with interference on intervention and primary outcome of this trial
Addresses
Primary Sponsor
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. med. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +497071295588
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +4970712986620
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +4970712986620
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +4970712986620
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BonnHeinemannstr. 253175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität UlmHelmholtzstr. 2089081 UlmGermany
- Telephone:
- +49-731-50022050
- Fax:
- +49-731-50022036
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-02-21
- Ethics committee number:
- 76/22
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-05-23
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- On request, anonymous individual patient data can be made available.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry