ArticleTrials2023
Rectal stimulation with prebiotics and probiotics before ileostomy reversal: a study protocol for a randomized controlled trial.
Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.
- Efferent limb stimulation prior to loop ileostomy closure: a systematic review and meta-analysis.Techniques in coloproctology · 2023Pooled it
- Delayed Loop Ileostomy Reversal Increases the Risk of Colitis and Clostridium difficile Infection.ANZ journal of surgery · 2026Article
- Risk factors for infectious enteritis after temporary stoma closure following colorectal cancer surgery: a retrospective cohort study.Annals of medicine and surgery (2012) · 2026Article
- Ileostoma as a promising tool in pathophysiological study and clinical intervention: a review from bench to beside.Frontiers in immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIleostomy closure is associated with a high rate of postoperative morbidity, and adynamic ileus is the most common complication, with an incidence of up to 32%. This complication is associated with delayed initiation of oral diet intake, abdominal distention, prolonged hospital stay, and more significant patient discomfort. The present study aims to evaluate the rectal stimulus with prebiotics and probiotics before ileostomy reversal.
methodsThis is a protocol study for an open-label randomized controlled clinical trial. Ethical approval was received (CAAE: 56551722.6.0000.0071). The following criteria will be used for inclusion: adult patients with rectal cancer stages cT3/4Nx or cTxN+ that underwent loop protection ileostomy, patients treated with neoadjuvant chemoradiotherapy, and patients who underwent laparoscopic or robotic total mesorectal excision. Patients will be randomized to one of two groups. The intervention group (with rectal stimulus): the patients will apply 500 ml of saline solution with 6 g of Simbioflora® rectally, once a day, for 15 days before ileostomy closure. The control group (without rectal stimulation): the patients will close the ileostomy with no previous rectal stimulus. The primary outcomes will be the adynamic ileus (need for postoperative nasogastric tube insertion; nausea/vomiting; or intolerance to oral feedings within the first 72 h) and intestinal transit (time to first evacuation/flatus).
resultsThe patient's enrollment starts in January 2023. We expect to finish in July 2025. DISCUSSION: The findings of this randomized clinical study may have important implications for managing patients undergoing ileostomy reversal.
trial registrationThis study is registered in the Brazilian Trial Registry (ReBEC) under RBR-366n64w. Registration date: 19/07/2022.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.