Clinical trial · Interventional
Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage. I t is most often performed after a low anterior resection indicated for lower-middle rectal cancer. A second operation is required for closure, with a morbidity of about 25%. Many studies have been completed in order to detect possible risk factors - both patient-related and surgery-related - for complications in ileostomy closure surgery. Currently, there is a lack of research studies focused on the preoperative management of these patients. Our purpose is to reduce the complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus. Main objective: To assess whether efferent loop stimulation two weeks before ileostomy closure decreases the incidence of postoperative paralytic ileus.
Conditions
Conditions (4)
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 - Stoma | — | UNRESOLVED | — |
| Ileus | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgical Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ileostomy stimulation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- During the two weeks prior to the ileostomy closure procedure, daily stimulation of the efferent loop will be performed by irrigation with 500 ml of physiological saline or 500 ml of warm water, preferably bottled, associated with a nutritional thickener. The patient will be instructed by a stomatotherapy nurse. Stimulation will be performed up to the day before the intervention. Kegel exercises will be suggested. Every surgeon will use his or her usual technique for all patients included in the study, regardless of the group assigned in the randomization. All patients in both groups will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol.
- interventionNames
- Other: Ileostomy stimulation
- type
- NO_INTERVENTION
- label
- Control
- description
- Direct standard surgery. Every surgeon will use his or her usual technique for all patients included in the study, regardless of the group assigned in the randomization. All patients in both groups will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age who undergo a scheduled protective ileostomy closure surgery, performed in rectal cancer surgery. All patients will follow a homogeneous protocol for testing the rectal anastomosis prior to closure, based on an opaque enema to rule out the presence of anastomotic leakage. Entry into the study does not affect the other surgical indications, in terms of time to ileostomy closure, type of operation or anaesthesia, or request for additional tests. Elective surgery. Patients who sign the informed consent document. Exclusion Criteria: * Patients undergoing simultaneous abdominal procedures at the time of ileostomy closure. History of protective ileostomy for a pathology other than rectal cancer. History of surgery in the ileal region.
References
Publications (2)
- DERIVEDArredondo J, Uriz A, Oliva I, Martin JI, Iglesias CN, Choolani E, Valle A, Rivera J, Jeri-McFarlane S, Romero JM, Gonzalez C, Alvarellos A, Tasende M, Gomez L, Lazaro L, Montcusi B, Tejedor P, Trujillo-Diaz J, de la Hermosa AR, Baixauli J, Nunez-Cordoba JM, Aliseda D; ILEOSTIM Trial Group. The ILEOSTIM trial: A multicentre randomised controlled trial evaluating the impact of efferent loop stimulation prior to ileostomy reversal on postoperative ileus. Colorectal Dis. 2026 May;28(5):e70448. doi: 10.1111/codi.70448. PMID 42092745
- DERIVEDBlanco N, Oliva I, Tejedor P, Pastor E, Alvarellos A, Pastor C, Baixauli J, Arredondo J. ILEOSTIM trial: a study protocol to evaluate the effectiveness of efferent loop stimulation before ileostomy reversal. Tech Coloproctol. 2023 Dec;27(12):1251-1256. doi: 10.1007/s10151-023-02807-0. Epub 2023 Apr 27. PMID 37106220