Clinical trial · Interventional
Diverting Loop Ileostomy: With or Without Rod
A Prospective Multicenter Randomized Controlled Clinical Trial to Compare the Method of Protective Diverting Loop Ileostomy With or Without the Support of a Plastic Rod
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difference found in interim analysis, not ethical to continue
Summary
Brief summary (as posted)
Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ileostomy | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diverting loop ileostomy without rod | Procedure | — | UNRESOLVED |
| Diverting loop ileostomy with rod | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- A
- description
- diverting loop ileostomy with rod
- interventionNames
- Procedure: Diverting loop ileostomy with rod
- type
- OTHER
- label
- B
- description
- diverting loop ileostomy without rod
- interventionNames
- Procedure: diverting loop ileostomy without rod
Primary outcomes (1)
- measure
- Severe stoma specific morbidity rate
- timeFrame
- postoperative during 2 weeks, 3 months postoperative
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients scheduled for planned protective loop ileostomy Exclusion Criteria * patients with long-term use of corticosteroids (\> 15 mg prednisolone equivalent) * immunosuppressive agent rapamune
References
Publications (10)
- BACKGROUNDRosen HR, Schiessel R. [Loop enterostomy]. Chirurg. 1999 Jun;70(6):650-5. doi: 10.1007/s001040050701. German. PMID 10427451
- BACKGROUNDGastinger I, Marusch F, Steinert R, Wolff S, Koeckerling F, Lippert H; Working Group 'Colon/Rectum Carcinoma'. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg. 2005 Sep;92(9):1137-42. doi: 10.1002/bjs.5045. PMID 15997447
- BACKGROUNDMoran B, Heald R. Anastomotic leakage after colorectal anastomosis. Semin Surg Oncol. 2000 Apr-May;18(3):244-8. doi: 10.1002/(sici)1098-2388(200004/05)18:33.0.co;2-6. PMID 10757890
- BACKGROUNDKaranjia ND, Corder AP, Bearn P, Heald RJ. Leakage from stapled low anastomosis after total mesorectal excision for carcinoma of the rectum. Br J Surg. 1994 Aug;81(8):1224-6. doi: 10.1002/bjs.1800810850. PMID 7953369
- BACKGROUNDSilva MA, Ratnayake G, Deen KI. Quality of life of stoma patients: temporary ileostomy versus colostomy. World J Surg. 2003 Apr;27(4):421-4. doi: 10.1007/s00268-002-6699-4. PMID 12658485
- BACKGROUNDAmin SN, Memon MA, Armitage NC, Scholefield JH. Defunctioning loop ileostomy and stapled side-to-side closure has low morbidity. Ann R Coll Surg Engl. 2001 Jul;83(4):246-9. PMID 11518371
- BACKGROUNDEdwards DP, Leppington-Clarke A, Sexton R, Heald RJ, Moran BJ. Stoma-related complications are more frequent after transverse colostomy than loop ileostomy: a prospective randomized clinical trial. Br J Surg. 2001 Mar;88(3):360-3. doi: 10.1046/j.1365-2168.2001.01727.x. PMID 11260099
- BACKGROUNDBada-Yllan O, Garcia-Osogobio S, Zarate X, Velasco L, Hoyos-Tello CM, Takahashi T. [Morbi-mortality related to ileostomy and colostomy closure]. Rev Invest Clin. 2006 Nov-Dec;58(6):555-60. Spanish.