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NCT04569331: ENESP
Efficacy of Stimulation of the Efferent Loop and Rehabilitation of the Pelvic Floor in the Quality of Life of Patients Who Underwent Anterior Resection of the Rectum (ENESP): Randomized Clinical Trial
NA trial testing Stimulation of efferent loop in Rectal Cancer in 25 participants. Completed in 13 December 2023.
13 December 2023
Quick facts
| Lead sponsor | Althaia Xarxa Assistencial Universitària de Manresa |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 25 |
| Start date | 15 May 2020 |
| Primary completion | 13 December 2023 |
| Estimated completion | 13 December 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Stimulation of efferent loop
- Rehabilitation pelvic floor
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Who can join
18 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Many of the patients operated with sphincter preservation will present an alteration of bowel function and defecation. This dysfunction is variable in its symptoms and severity, and manifests itself in the form of urgency, incontinence and fragmentation of faeces, with repeated, incomplete or difficult evacuations. The set of these symptoms constitutes what is known as anterior resection syndrome (ARS), which can negatively influence the quality of life of the operated patients and constitutes the main objective of the study to be investigated. From this study, the investigators want to evaluate the efficacy of stimulation of the efferent loop prior to the closure of the ileostomy along with rehabilitation of the pelvic floor after the closure of the ileostomy, in the quality of life of patients who underwent anterior resection of the rectum. A non-pharmacological randomized clinical trial will be conducted, comparing a control group (usual clinical practice), with respect to the experimental group where stimulation of the efferent loop will be performed prior to the closure of the ostomy along with pelvic floor rehabilitation after the closure of the latter. The main dependent variable will be the quality of life evaluated according to the QLQ CR-29 questionnaire, and secondary dependent variables will be evaluated postoperative paralytic ileus and the previous resection syndrome using the LARS scale.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.
Vuyyuru SK, Ma C, Sharma T, Nguyen TM, et al · · 2024 · cited 3× · PMID 38135729 · DOI 10.1093/ibd/izad293
Verify or expand the search:
- PubMed search for NCT04569331
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rectal Cancer
Currently open trials in the same condition.
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- NCT07501845 — Registry Maastro Applicator · recruiting
- NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
- NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · recruiting
Other Althaia Xarxa Assistencial Universitària de Manresa trials
Trials by the same sponsor.
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- NCT05526053 — Lung Volume Preservation During Extubation · NA · completed
- NCT05663788 — Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04569331 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Althaia Xarxa Assistencial Universitària de Manresa
- Last refreshed: 1 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04569331.
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