Rectal Cancer Clinical Trial
— PRELARSOfficial title:
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
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 1, 2021 |
Est. primary completion date | October 2, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Garazi Elorza | San Sebastián | Guipuzcoa |
Lead Sponsor | Collaborator |
---|---|
Hospital Donostia |
Spain,
Altomare 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. — View Citation
Battersby 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. — View Citation
Emmertsen 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. — View Citation
Enriquez-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. — View Citation
Lee 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of a multimodal package of prehabilitation and rehabilitation in patients with low anterior resection syndrome | 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. | October 2020- September 2021 | |
Secondary | Feasibility of introduction of APP for the education and follow-up | 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. | October 2020- September 2021 | |
Secondary | Assessment of the improvement of scores in faecal incontinence, | To assess the effect of multimodal interventions on aspects of fecal incontinence, measured by the Vaizey Faecal Incontinence score (Vaizey Score 0-24; 0 perfect continence and 24 is total incontinence). | October 2020- September 2021 | |
Secondary | Analysis of the correlation between estimated POLARS score and postoperative LARS score | To analyze the correlation between the estimated preoperative POLARS score and the postoperative LARS score collected at 6 months and one year after radical surgery or closure of the derivative stoma. (LARS score 0-42; 0-20 No LARS; 21-29 Minor LARS; 30-42 Major LARS) | October 2020- September 2021 | |
Secondary | Assessment of the improvement of quality of life | To assess the effect of multimodal interventions on aspects of quality of life, measured by the EORTC QLQ-30 quality of life score (0-100; higher measures mean better quality of life). | October 2020- September 2021 | |
Secondary | Assessment of the improvement of pelvic floor contractility | To assess the effect of multimodal interventions on pelvic floor contractility with the results of anal manometries, the modified Oxford scale (0-5; 0 means No contraction and 5 means Strong contraction). | October 2020- September 2021 |
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