Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)

NCT06519006 | Recruiting

• 1 other identifier: CHIRURGIA2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this randomized study will be to determine the effectiveness of pelvic floor exercises on the incidence or severity of LAR syndrome in patients after mini-invasive rectal resection. The main questions it aims to answer are:

• Does pelvic floor exercise after low anterior resection prevent LARS (low anterior resection syndrome)?
• What is the adherence of patients to prescribed home exercise after surgery?
• Quality of life after LAR Researchers will compare the group of patients with pelvic floor exercises to those without and determine the occurrence and severity of LARS. Participants will:
• under the professional guidance of a physiotherapist, the day before surgery and in the first 4 postoperative days be educated to exercise the pelvic floor
• continue exercise at home for a month (according to the instructions together with the infographic)

Conditions

Prevention; LARS - Low Anterior Resection Syndrome; Pelvic Floor Disorders; Rectal Cancer; Low Anterior Resection

Keywords

prevention, LARS, pelvic floor exercise, LAR

Outcome Measures

Primary Outcomes (1)

• The number of participants who develop (or what degree) LAR syndrome with or without pelvic floor exercises after LAR, ascertained by LARS questionnaire.

  Patients may develop varying degrees of functional impairment - defecation urgency, fecal incontinence, increased frequency of stool, fragmentation and numerous bowel movements in a short period, problems with emptying or incomplete stool evacuation, increased intestinal flatulence, diarrhea, constipation or change in stool consistency. Participants will exercise at home. 1,6,12 months after surgery, the Low Anterior Resection Syndrome (LARS) questionnaire will be sent to patients. LARS questionnaire contains 5 questions about bowel functions. It is officially translated into the Slovak language. Final score range between 0-42. 0-20: NO LARS, 21-29: minor LARS, 30 - 42: major LARS.

  4 weeks

Secondary Outcomes (1)

• Adherence of patients to prescribed home exercise after surgery, determined by the Exercise Adherence Rating Scale (EARS)

  4 weeks

Other Outcomes (1)

• Quality of life after LAR measured by WHOQOL - BREF

  1 - 12 months after LAR

Study Arms (2)

Control group - usual management

NO INTERVENTION

This arm will be managed as usual - without specific pelvic floor exercises after surgery, and 1, 6 and 12 months after low anterior resection, patients will be questioned about the possible development of LARS.

Intervention group - specific pelvic floor exercise after LAR

EXPERIMENTAL

This arm will be instructed to exercise pelvic floor after low anterior resection for one month and 1, 6, and 12 months postoperatively will be questioned about the possible development of LARS. One month after surgery they will also be questioned about adherence to prescribed exercise.

Procedure: Pelvic floor exercise

Interventions

Pelvic floor exercise PROCEDURE

Exercises aimed at this issue consist of identification and isolated contraction of the pelvic floor muscles as well as their activation during complex movements and daily activities. During the engagement of the pelvic floor muscles, the correct engagement of the respiratory activity is important. Within the exercise units, exercises are used from sphincter contraction, through the gradual activation of individual pelvic floor layers in various ways, to their complex involvement in movement activities. Exercises are practiced repeatedly, at different frequencies and intensities that gradually increase, 4-5 times per day.

Intervention group - specific pelvic floor exercise after LAR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitive functions make it possible to understand and sign the patient\'s informed consent and consent to participate in the study
• Surgical procedure - mini-invasive low anterior rectal resection

You may not qualify if:

• not agreeing to participate in the study
• request to practice pelvic floor exercises despite being in the control group
• non-compliance
• serious psychiatric diagnoses

Sponsors & Collaborators

• F. D. Roosevelt University Hospital: lead

Study Sites (1)

F.D.Roosevelt University Hospital in Banská Bystrica

Banská Bystrica, 97517, Slovakia

RECRUITING

Related Publications (7)

• Allgayer H, Dietrich CF, Rohde W, Koch GF, Tuschhoff T. Prospective comparison of short- and long-term effects of pelvic floor exercise/biofeedback training in patients with fecal incontinence after surgery plus irradiation versus surgery alone for colorectal cancer: clinical, functional and endoscopic/endosonographic findings. Scand J Gastroenterol. 2005 Oct;40(10):1168-75. doi: 10.1080/00365520510023477.

  PMID: 16165701 BACKGROUND

• Asnong A, D'Hoore A, Van Kampen M, Wolthuis A, Van Molhem Y, Van Geluwe B, Devoogdt N, De Groef A, Guler Caamano Fajardo I, Geraerts I. The Role of Pelvic Floor Muscle Training on Low Anterior Resection Syndrome: A Multicenter Randomized Controlled Trial. Ann Surg. 2022 Nov 1;276(5):761-768. doi: 10.1097/SLA.0000000000005632. Epub 2022 Jul 27.

  PMID: 35894434 BACKGROUND

• Laforest A, Bretagnol F, Mouazan AS, Maggiori L, Ferron M, Panis Y. Functional disorders after rectal cancer resection: does a rehabilitation programme improve anal continence and quality of life? Colorectal Dis. 2012 Oct;14(10):1231-7. doi: 10.1111/j.1463-1318.2012.02956.x.

  PMID: 22268662 BACKGROUND

• Liu CH, Chen CH, Lee JC. Rehabilitation exercise on the quality of life in anal sphincter-preserving surgery. Hepatogastroenterology. 2011 Sep-Oct;58(110-111):1461-5. doi: 10.5754/hge11160. Epub 2011 Jul 15.

  PMID: 21940307 BACKGROUND

• Lin KY, Granger CL, Denehy L, Frawley HC. Pelvic floor muscle training for bowel dysfunction following colorectal cancer surgery: A systematic review. Neurourol Urodyn. 2015 Nov;34(8):703-12. doi: 10.1002/nau.22654. Epub 2014 Aug 23.

  PMID: 25156929 BACKGROUND

• Pucciani F, Ringressi MN, Redditi S, Masi A, Giani I. Rehabilitation of fecal incontinence after sphincter-saving surgery for rectal cancer: encouraging results. Dis Colon Rectum. 2008 Oct;51(10):1552-8. doi: 10.1007/s10350-008-9312-6. Epub 2008 May 2.

  PMID: 18452041 BACKGROUND

• Emile SH, Garoufalia Z, Barsom S, Horesh N, Gefen R, Zhou P, Wexner SD. Systematic review and meta-analysis of randomized clinical trials on the treatment of low anterior resection syndrome. Surgery. 2023 Jun;173(6):1352-1358. doi: 10.1016/j.surg.2023.02.010. Epub 2023 Apr 1.

  PMID: 37012144 BACKGROUND

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Pelvic Floor Disorders; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Ľubomír Marko, MD,ass. prof

  F. D. Roosevelt University Hospital

  STUDY DIRECTOR

• Barbara Mrázová, MD,MPH

  F. D. Roosevelt University Hospital

  STUDY CHAIR

Central Study Contacts

Barbara Mrázová, MD,MPH

CONTACT

+421918964357; barbara.mrazova19@gmail.com

Viktória Durajová, Ing,PhD,MBA

CONTACT

+421907312462; vdurajova@nspbb.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 25, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5th June 2024 for at least 5 years
• Access Criteria: EU Open Research Repository

Locations

SL (1)