Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings

NCT07640113 | Not Yet Recruiting

• 1 other identifier: HCB/2026/0615
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND Loop ileostomies are a type of stoma frequently used to protect high-risk colorectal anastomoses (surgical reconnection of the intestines), for example following rectal cancer resection. Temporary diversion of intestinal transit does not reduce the risk of anastomotic failure, but it does lower the morbidity and mortality associated with potential pelvic sepsis. Unfortunately, a second surgical procedure is required to restore intestinal continuity, and this carries its own risk of complications, the most common being postoperative ileus (temporary paralysis of bowel motility associated with abdominal distension, absence of bowel movements, nausea, and vomiting), which occurs in up to 20% of cases. Several strategies have been proposed to reduce this problem, including stimulation of the efferent limb of the ileostomy (the part that is connected to the unused colon). This intervention consists of instilling a substance through the efferent limb of the ileostomy into the colon, simulating natural intestinal transit. It emerged as a harmless alternative aimed at reversing changes in the excluded colon in preparation for restoration of intestinal continuity. Several Spanish studies have investigated this technique, concluding that it is safe and significantly reduces the rate of postoperative ileus, thereby shortening hospital stay. Regarding the mechanism by which this intervention may be effective, there are studies investigating the changes that occur during diversion of intestinal transit:

1. 1.Histopathology: reduced muscular contractility and the presence of intestinal villi in the efferent intestinal limb and excluded colon, which improve once intestinal flow is restored.
2. 2.Microbiome: significant loss of microbiota in the defunctionalized colon, which progressively recovers with natural intestinal transit and reintroduction of a fiber-rich diet.
3. 3.Control (no intervention other than the usual preoperative protocol)
4. 4.Stimulation with serum and thickener
5. 5.Stimulation with own stoma output
6. 6.Stoma output
7. 7.Stool, before stimulation, if performed
8. 8.Stool, after stimulation, if performed
9. 9.Stool, a month after surgery

Conditions

Ileostomy Stoma; Stoma Stimulation; Microbiome Analysis

Keywords

efferent limb stimulation; ileostomy closure; colorectal microbiome

Outcome Measures

Primary Outcomes (2)

• Changes in colorectal microbiome before and after efferent limb stimulation prior to stoma closure.

  Descriptive analysis of the microbiome profiles of the three groups of patients (control, stimulation with serum, stimulation with own stoma output).

  From enrollment to the end of follow-up at 3 months.

• Changes in colorectal tissue before and after efferent limb stimulation prior to stoma closure.

  Description of the tissue obtained by biopsy of the rectum, before and after stimulation of the ileostomy.

  From the time of first biopsy (before stimulation) to the second one (surgery day).

Secondary Outcomes (3)

• Postoperative complications after stoma closure.

  From the surgery (ileostomy closure) to 30 days follow-up.

• Functional outcomes after efferent limb stimulation (LARS score)

  From enrollment to the end of follow-up a 3 months.

• Functional outcomes after efferent limb stimulation (Vaizey score)

  From enrollment to the end of follow-up at 3 months.

Study Arms (3)

Control

NO INTERVENTION

No efferent limb stimulation.

Serum stimulation

ACTIVE COMPARATOR

Efferent limb stimulation with serum and thickener.

Other: Serum stimulation

Physiological stimulation

ACTIVE COMPARATOR

Efferent limb stimulation with the patient's own stoma output.

Other: Physiological stimulation

Interventions

Serum stimulation OTHER

The intervention has been described in previous studies, but the investigation of the microbiome changes associated with the obtained clinical results hasn't been described to date. Also, a study with three arms hasn't been published to date.

Also known as: efferent limb stimulation, physiological stimulation

Serum stimulation

Physiological stimulation OTHER

The intervention has been described in previous studies, but the investigation of the microbiome changes associated with the obtained clinical results hasn't been described to date. Also, a study with three arms hasn't been published to date.

Physiological stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 yo and older, with a loop ileostomy after colorectal surgery for malignant or benign disease and a barium enema that rules out colorectal anastomotic leak or stenosis.
• Patients must be self-sufficient in their stoma care or dispose of assistance by a family member or healthcare provider.
• Patients must reside no further than 50km from the hospital and dispose of postoperative home-assistance by a family member or healthcare provider.

You may not qualify if:

• Patients with a terminal ileostomy or a closed distal limb, inaccesible to preoperative stimulation.
• Patients with the diagnosis of inflammatory bowel disease.
• Patients incapable of comprehending or signing the informed consent.

Sponsors & Collaborators

• Hospital Mutua de Terrassa: collaborator
• Hospital Clinic of Barcelona: lead
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator

Related Publications (20)

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  PMID: 25950922 BACKGROUND

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  PMID: 42092745 BACKGROUND

• Liu Z, Fang L, Lv L, Niu Z, Hou L, Chen D, Zhou Y, Guo D. Self-administered succus entericus reinfusion before ileostomy closure improves short-term outcomes. BMC Surg. 2021 Dec 28;21(1):440. doi: 10.1186/s12893-021-01444-4.

  PMID: 34961502 BACKGROUND

• Xia F, Zou Y, Zhang Q, Wu J, Sun Z. A novel nomogram to predict low anterior resection syndrome (LARS) after ileostomy reversal for rectal cancer patients. Eur J Surg Oncol. 2023 Feb;49(2):452-460. doi: 10.1016/j.ejso.2022.10.015. Epub 2022 Oct 23.

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• Vogel I, Reeves N, Tanis PJ, Bemelman WA, Torkington J, Hompes R, Cornish JA. Impact of a defunctioning ileostomy and time to stoma closure on bowel function after low anterior resection for rectal cancer: a systematic review and meta-analysis. Tech Coloproctol. 2021 Jul;25(7):751-760. doi: 10.1007/s10151-021-02436-5. Epub 2021 Apr 1.

  PMID: 33792822 BACKGROUND

• Rombey T, Panagiotopoulou IG, Hind D, Fearnhead NS. Preoperative bowel stimulation prior to ileostomy closure to restore bowel function more quickly and improve postoperative outcomes: a systematic review. Colorectal Dis. 2019 Sep;21(9):994-1003. doi: 10.1111/codi.14636. Epub 2019 May 7.

  PMID: 30963659 BACKGROUND

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  PMID: 38095756 BACKGROUND

• Rodriguez-Padilla A, Morales-Martin G, Perez-Quintero R, Gomez-Salgado J, Balongo-Garcia R, Ruiz-Frutos C. Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure. Nutrients. 2021 Feb 15;13(2):626. doi: 10.3390/nu13020626.

  PMID: 33671968 BACKGROUND

• Ocana J, Garcia-Perez JC, Labalde-Martinez M, Rodriguez-Velasco G, Moreno I, Vivas A, Clemente-Esteban I, Ballestero A, Abadia P, Ferrero E, Fernandez-Cebrian JM, Die J. Can physiological stimulation prior to ileostomy closure reduce postoperative ileus? A prospective multicenter pilot study. Tech Coloproctol. 2022 Aug;26(8):645-653. doi: 10.1007/s10151-022-02620-1. Epub 2022 May 21.

  PMID: 35596903 BACKGROUND

• Fernandez Lopez F, Gonzalez Lopez J, Paz Novo M, Ladra Gonzalez MJ, Paredes Cotore J. Stimulation the efferent limb before loop ileostomy closure with short chain fatty acids. Cir Esp (Engl Ed). 2019 Jan;97(1):59-61. doi: 10.1016/j.ciresp.2018.06.018. Epub 2018 Oct 15. No abstract available. English, Spanish.

  PMID: 30337046 BACKGROUND

• Garfinkle R, Demian M, Sabboobeh S, Moon J, Hulme-Moir M, Liberman AS, Feinberg S, Hayden DM, Chadi SA, Demyttenaere S, Samuel L, Hotakorzian N, Quintin L, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Boutros M; Bowel Stimulation Research Collaborative. Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial. Surg Endosc. 2023 May;37(5):3934-3943. doi: 10.1007/s00464-022-09510-5. Epub 2022 Aug 19.

  PMID: 35984521 BACKGROUND

• Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.

  PMID: 25380005 BACKGROUND

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  PMID: 37055940 BACKGROUND

• Ekelund KM, Ekblad E. Structural, neuronal, and functional adaptive changes in atrophic rat ileum. Gut. 1999 Aug;45(2):236-45. doi: 10.1136/gut.45.2.236.

  PMID: 10403736 BACKGROUND

• Courtier R, Pares D, Silva CA, Gil MJ, Pascual M, Alonso S, Pera M, Grande L. [Clinical results of loop ileostomy closures in rectal cancer surgical patients. Effect of chemotherapy in the waiting period]. Cir Esp. 2010 Nov;88(5):308-13. doi: 10.1016/j.ciresp.2010.08.001. Spanish.

  PMID: 20889147 BACKGROUND

• Sharma A, Deeb AP, Rickles AS, Iannuzzi JC, Monson JR, Fleming FJ. Closure of defunctioning loop ileostomy is associated with considerable morbidity. Colorectal Dis. 2013 Apr;15(4):458-62. doi: 10.1111/codi.12029.

  PMID: 22974343 BACKGROUND

• Garfinkle R, Savage P, Boutros M, Landry T, Reynier P, Morin N, Vasilevsky CA, Filion KB. Incidence and predictors of postoperative ileus after loop ileostomy closure: a systematic review and meta-analysis. Surg Endosc. 2019 Aug;33(8):2430-2443. doi: 10.1007/s00464-019-06794-y. Epub 2019 Apr 17.

  PMID: 31020433 BACKGROUND

Study Officials

• Romina Pena, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romina Pena, MD

CONTACT

+34 617333153; PENA@clinic.cat

Miguel Pera, MD, PhD

CONTACT

+34 932275400; PERA@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 1 month and ending 1 year after the publication of results.
• Access Criteria: IPD and supporting information of this study might be accessed by fellow researchers with a future study, related to our published findings. Researchers must submit a request for data sharing by contacting the principal investigator, who will also be the corresponding author in the future published data. The request to access IPD will be reviewed by the principal investigator (Romina Pena).