Clinical trial · Observational
Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Feasibility and Impact of a Trimodal Prehabilitation and Rehabilitation Program to Reduce the Predicted Low Anterior Resection Syndrome After Radical Rectal Cancer Treatment. A Non-Randomized Prospective Study Phase II. PRELARS Study
- 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)
Patients with sphincter saving procedures of rectal cancer usually experience intestinal dysfunction, including difficulty emptying the bowel and faecal incontinence, leading to a detriment in the quality of life. A prospective study is proposed to measure de feasibility and the impact of a continuous care programme for the prevention or reduction of intestinal dysfunction disorders. The intervention lies on prehabilitation and rehabilitation with physiotherapy, biofeedback and neuromodulation, is assisted by a telematic information system (APP for the monitoring of education on physiotherapy and surveillance).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Faecal Incontinence | — | UNRESOLVED | — |
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Impact of a multimodal package of prehabilitation and rehabilitation in patients with low anterior resection syndrome
- timeFrame
- October 2020- September 2021
- description
- To analyze the feasibility of the introduction of a multimodal package of integrated interventions (educational, pelvic floor physiotherapy, biofeedback and posterior tibial neurostimulation-PTNS-) with the objective of reducing the severity of predictable intestinal dysfunction after the radical surgery for rectal cancer, measured by the number of patients that complete the treatment.
Secondary outcomes (5)
- measure
- Feasibility of introduction of APP for the education and follow-up
- timeFrame
- October 2020- September 2021
- description
- Compliance comprehensive outpatient therapeutic program, supported by the introduction of an APP device; measured by the proportion of patients that use the APP and the use that gives each patient.
- measure
- Assessment of the improvement of scores in faecal incontinence,
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Low anterior resection of the rectum with mesorectal excision and colorectal anastomosis with or without protective ileostomy * POLARS score \>20 * over 18 years of age * give their informed consent * Patients who can perform a pelvic floor physiotherapy program and to tibial nerve stimulation. Exclusion Criteria: * POLARS score less than 20 * LARS-minor or non-LARS * The existence of residual or distant locoregional disease * Inflammatory bowel disease (IBD) * A previous known diagnosis of irritable bowel syndrome (IBS) * Intestinal resections other than the rectum * Existence of anastomotic complications * Inability to perform pelvic muscle physiotherapy, presence of trophic disorders in the ankles (post-febile syndrome) * Known diabetic neuropathy * Carriers of pacemakers or implantable defibrillators, and patients who are have previously performed SNS or PTNS.
References
Publications (5)
- BACKGROUNDEmmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21. PMID 22504191
- BACKGROUNDEnriquez-Navascues JM, Labaka-Arteaga I, Aguirre-Allende I, Artola-Etxeberria M, Saralegui-Ansorena Y, Elorza-Echaniz G, Borda-Arrizabalaga N, Placer-Galan C. A randomized trial comparing transanal irrigation and percutaneous tibial nerve stimulation in the management of low anterior resection syndrome. Colorectal Dis. 2020 Mar;22(3):303-309. doi: 10.1111/codi.14870. Epub 2019 Oct 21. PMID 31585495
- BACKGROUNDBattersby NJ, Bouliotis G, Emmertsen KJ, Juul T, Glynne-Jones R, Branagan G, Christensen P, Laurberg S, Moran BJ; UK and Danish LARS Study Groups. Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score. Gut. 2018 Apr;67(4):688-696. doi: 10.1136/gutjnl-2016-312695. Epub 2017 Jan 23. PMID 28115491
- BACKGROUNDAltomare DF, Picciariello A, Ferrara C, Digennaro R, Ribas Y, De Fazio M. Short-term outcome of percutaneous tibial nerve stimulation for low anterior resection syndrome: results of a pilot study. Colorectal Dis. 2017 Sep;19(9):851-856. doi: 10.1111/codi.13669. PMID 28371160
- BACKGROUNDLee KH, Kim JS, Kim JY. Efficacy of biofeedback therapy for objective improvement of pelvic function in low anterior resection syndrome. Ann Surg Treat Res. 2019 Oct;97(4):194-201. doi: 10.4174/astr.2019.97.4.194. Epub 2019 Oct 1. PMID 31620393