Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.

NCT04612569 | Unknown DMC

• 1 other identifier: ELO-PRE-2020-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer; Low Anterior Resection Syndrome; Faecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Feasibility of introduction of APP for the education and follow-up

  October 2020- September 2021

• Assessment of the improvement of scores in faecal incontinence,

  October 2020- September 2021

• Analysis of the correlation between estimated POLARS score and postoperative LARS score

  October 2020- September 2021

• Assessment of the improvement of quality of life

  October 2020- September 2021

• Assessment of the improvement of pelvic floor contractility

  October 2020- September 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rectal cancer who are expected to undergo a low anterior resection of the rectum with mesorectal excision and colorectal anastomosis with or without protective ileostomy, older than 18 years, who give their informed consent, and who can carry out a pelvic floor physiotherapy program and be susceptible to tibial neurostimulation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Donostia: lead

Study Sites (1)

Garazi Elorza

San Sebastián, Guipuzcoa, 20014, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 22504191 BACKGROUND

• 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.

  PMID: 31585495 BACKGROUND

• 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.

  PMID: 28115491 BACKGROUND

• 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.

  PMID: 28371160 BACKGROUND

• 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.

  PMID: 31620393 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome; Encopresis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Central Study Contacts

Garazi Elorza, Medical Doctor

CONTACT

619939947; garazielorza@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD; Head of service

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: November 3, 2020
• Study Start: October 1, 2020
• Primary Completion: October 2, 2020
• Study Completion: April 1, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)