Clinical trial · Interventional
Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial
Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial (PERECARE TRIAL)
- 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)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Dysfunction | — | UNRESOLVED | — |
| Fecal Incontinence | — | UNRESOLVED | — |
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectum Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional group | Behavioral | — | UNRESOLVED |
| Pelvic Floor Physiotherapy (PFR) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pelvic Floor Physiotherapy (PFR) group
- description
- 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.
- interventionNames
- Behavioral: Pelvic Floor Physiotherapy (PFR)
- type
- ACTIVE_COMPARATOR
- label
- Conventional group
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (9)
- BACKGROUNDLin 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
- BACKGROUNDVisser 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
- BACKGROUNDMaris 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
- RESULTCamilleri-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
- RESULTVironen 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
- RESULTLiu 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
- RESULTAllgayer 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.