Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial

NCT06524362 | Not Yet Recruiting DMC

• 1 other identifier: PERECARE
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Study Purpose: This study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care. Background: Rectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2) Current Knowledge: Advances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery. Past studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5) Need for the Study: There is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most. Study Design: This study is a randomized controlled trial that will:

• Compare PFR to usual care in patients after LAR surgery.
• Focus on bowel control and quality of life.
• Provide detailed insights to improve aftercare for rectal cancer patients.

Conditions

Rectal Cancer; Rectum Neoplasm; Rectal Neoplasms; Rectal Adenocarcinoma; Low Anterior Resection Syndrome; Fecal Incontinence; Bowel Dysfunction

Keywords

Pelvic Floor Rehabilitation; Low Anterior Resection; Ultra Low Anterior Resection; Rectal Cancer Surgery; Post operative care; Bowel function; Quality of life; Randomized controlled trial; Fecal Urgency; Pelvic Floor Muscle Training; Oncological outcomes

Outcome Measures

Primary Outcomes (1)

• WEXNER INCONTINENCE SCORE

  The Wexner Incontinence Score assesses fecal incontinence severity using patient-reported symptoms. Scores range from 0 (no incontinence) to 20 (severe incontinence), with higher scores indicating worse outcomes. Patients evaluate bowel control, leakage frequency, and lifestyle impacts, providing crucial data for treatment evaluation and comparison in clinical trials.

  Baseline score 6 weeks post-low anterior resection (LAR) or 6 weeks post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 18 weeks post-LAR or post-ileostomy closure.

Secondary Outcomes (2)

• Low Anterior Resection Syndrome score (LARS)

  Baseline score 6 weeks post-low anterior resection (LAR) or 6 weeks post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 18weeks post-LAR or 18 weeks post-ileostomy closure.

• Quality of life measure QORTC CR 29

  Baseline score 6 weeks post-low anterior resection (LAR) or post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 6 months post-LAR or 18 weeks post-ileostomy closure.

Study Arms (2)

Pelvic Floor Physiotherapy (PFR) group

EXPERIMENTAL

Patients completing three months post-low anterior resection (LAR) for rectal cancer or six weeks post-diversion ileostomy closure following LAR will be recruited to Pelvic Floor Rehabilitation (PFR) group after randomization. Intervention: Participants will undergo a structured pelvic floor physiotherapy program for three months. The program includes: Eight Personal Sessions: Each session lasts 45 minutes. Frequency: * Once a week for the first month (four sessions). * Biweekly for the next two months (four sessions). Home Exercises: Participants will be guided on pelvic floor exercises to be performed at home throughout the three months. Usual Care: In addition to the pelvic floor rehabilitation, participants will receive the standard postoperative care for rectal cancer surgery.

Behavioral: Pelvic Floor Physiotherapy (PFR)

Conventional group

ACTIVE COMPARATOR

Patients completing three months post-low anterior resection (LAR) for rectal cancer or six weeks post-diversion ileostomy closure following LAR will be recruited to Conventional group after randomization. Recruited subjects in the conventional group recieves usual care following low anterior resection such as fluid intake, fiber intake, diet, toilet posture, life style advice etc

Behavioral: Conventional group

Interventions

Pelvic Floor Physiotherapy (PFR) BEHAVIORAL

Intervention: Participants will undergo a structured pelvic floor physiotherapy program for three months. The program includes: Eight Personal Sessions: Each session lasts 45 minutes. Frequency: Once a week for the first month (four sessions). Biweekly for the next two months (four sessions). Home Exercises: Participants will be guided on pelvic floor exercises to be performed at home throughout the three months.

Pelvic Floor Physiotherapy (PFR) group

Conventional group BEHAVIORAL

Patients completing three months post-low anterior resection (LAR) for rectal cancer or six weeks post-diversion ileostomy closure following LAR will be recruited to Conventional group after randomization. Recruited subjects in the conventional group recieves usual care following low anterior resection such as fluid intake, fiber intake, diet, toilet posture, life style advice etc

Conventional group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Adults aged 18 years or older.
• Surgical Procedure: Have undergone Low Anterior Resection (LAR) for rectal cancer.
• Cognitive Ability: Capable of understanding and completing the questionnaires effectively

You may not qualify if:

• Medical History: History of proctitis, ulcerative colitis, or Crohn's disease.
• Surgical Extent: Extensive resection (beyond Total Mesorectal Excision - TME) for
• locally advanced (T4) tumors, patients undergoing APR.
• Surgical Complications: History of anastomotic leakage.
• Recent Physiotherapy: History of invasive physiotherapy within the past 6 months.
• Mental or Physical Inabilities: Inability to undergo Pelvic Floor Rehabilitation due to mental or physical limitations

Sponsors & Collaborators

• GEM Hospital & Research Center: lead
• JOGO Health Pvt Ltd: collaborator

Study Sites (1)

GEM Hospital & Research Center

Coimbatore, Tamil Nadu, 641045, India

Location

Related Publications (9)

• 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

• Visser WS, Te Riele WW, Boerma D, van Ramshorst B, van Westreenen HL. Pelvic floor rehabilitation to improve functional outcome after a low anterior resection: a systematic review. Ann Coloproctol. 2014 Jun;30(3):109-14. doi: 10.3393/ac.2014.30.3.109. Epub 2014 Jun 23.

  PMID: 24999460 BACKGROUND

• Maris A, Devreese AM, D'Hoore A, Penninckx F, Staes F. Treatment options to improve anorectal function following rectal resection: a systematic review. Colorectal Dis. 2013 Feb;15(2):e67-78. doi: 10.1111/codi.12036.

  PMID: 23017030 BACKGROUND

• Camilleri-Brennan J, Ruta DA, Steele RJ. Patient generated index: new instrument for measuring quality of life in patients with rectal cancer. World J Surg. 2002 Nov;26(11):1354-9. doi: 10.1007/s00268-002-6360-2. Epub 2002 Sep 26.

  PMID: 12297930 RESULT

• Vironen JH, Kairaluoma M, Aalto AM, Kellokumpu IH. Impact of functional results on quality of life after rectal cancer surgery. Dis Colon Rectum. 2006 May;49(5):568-78. doi: 10.1007/s10350-006-0513-6.

  PMID: 16583289 RESULT

• 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 RESULT

• 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 RESULT

• Kim KH, Yu CS, Yoon YS, Yoon SN, Lim SB, Kim JC. Effectiveness of biofeedback therapy in the treatment of anterior resection syndrome after rectal cancer surgery. Dis Colon Rectum. 2011 Sep;54(9):1107-13. doi: 10.1097/DCR.0b013e318221a934.

  PMID: 21825890 RESULT

• 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 RESULT

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome; Fecal Incontinence; Intestinal Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Harshavardhana H P, MS DrNB (IP)

  GEM Coimbatore

  PRINCIPAL INVESTIGATOR

• RAJAPANDIAN S, DNB FRCS(Ed)

  GEM Coimbatore

  STUDY DIRECTOR

• PALANIVELU C, MS Mch FRCS

  GEM Coimbatore

  STUDY CHAIR

• HARISH KAKKILAYA, MS FACRSI

  GEM Coimbatore

  STUDY DIRECTOR

• SHANKAR B, MS DrNB FRCS

  GEM Coimbatore

  STUDY DIRECTOR

Central Study Contacts

Harshavardhana H P, MS DrNB (IP)

CONTACT

9113200790; Harshavardhanmmc@gmail.com

Rajapandian S, DNB FRCS(Ed)

CONTACT

9843026290; srajapandian@rediffmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD will be available 6 months after publication and will remain accessible for a period of 10 years.
• Access Criteria: Access to the IPD will be granted to researchers who provide a methodologically sound proposal and are affiliated with academic institutions or research organizations. Requests will be reviewed by a data access committee based on scientific merit, feasibility, and ethical considerations. The review process will take approximately 4-6 weeks. Researchers can request access by submitting a proposal via our online application form. All researchers granted access will be required to sign a data use agreement to ensure responsible use of the data

Locations

IN (1)