Clinical trial NCT06524362: Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial
Official title: Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial (PERECARE TRIAL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
Collaborators: name: JOGO Health Pvt Ltd
First posted: 2024-07-29
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study will investigate the effects of pelvic floor rehabilitation (PFR) on bowel function and quality of life in patients who have undergone low anterior resection (LAR) for rectal cancer. The study aims to provide a more comprehensive understanding of effective aftercare for these patients. Here are the key components of the study protocol:

Study Design

Type: Randomized controlled trial.

Participants: Patients who have undergone LAR for rectal cancer.

Interventions: Pelvic floor rehabilitation compared to usual care.

Primary Outcomes: Fecal incontinence.

Secondary Outcomes: Quality of life, LARS score.

Procedures. Screening and Enrollment: Pateint with rectal cancer undergoing sphincter preserving surgeries and who are willing to participate will be enrolled after thorugh explaination of the study.

Randomization: Post three months following Low anterior resection or post 6 weeks following closure of diversion ileostomy, participants will be randomly assigned to either the PFR group or the usual care group using computer generated randomization.

Intervention: The PFR group will receive a structured pelvic floor rehabilitation program by a trained pelvic physiotherapist along with usual care. The PFR program includes three components:

1. Pelvic Floor Muscle Training: Focused on increasing maximum strength, extending contraction duration, and enhancing pelvic floor muscle coordination.
2. Biofeedback: A behavior-based therapy with a feedback loop, enabling patients to visualize the impact of muscle actions and improve pelvic floor movements.
3. Rectal Balloon Training: Simulating resistance to the urge to defecate, aiding in LARS prevention.

   This will be carried out as in-person sessions weekly for the first month and biweekly for the next 2 months, totaling 8 sessions over 3 months. Additionally, home sessions will be conducted under phone guidance. Patients are required to fill out relevant questionnaires before and after completing the PFR program.

   The usual care group will receive standard post-surgical care.

   Baseline scores: Wexner's score, LARS score, EORTC CR 29 score taken before the start of the study.

   Follow-up: Participants will be followed for three months and Wexner's scores, LARS, EORTC CR 29 score will be taken.

   Quality Assurance

   Data Validation: Data entered into the registry will be validated against predefined rules for range and consistency.

   Source Data Verification: Data accuracy will be assessed by comparing registry data to external sources such as medical records.

   Data Dictionary: Detailed descriptions of each variable, including source, coding information, and normal ranges, will be maintained.

   Standard Operating Procedures (SOPs)

   Recruitment and Data Collection: SOPs will ensure consistent recruitment and data collection processes.

   Data Management and Analysis: Procedures for managing and analyzing data will be clearly defined.

   Adverse Event Reporting: SOPs will include protocols for reporting adverse events.

   Change Management: Procedures for handling changes in the study protocol will be in place.

   Sample Size Assessment:

   Previous Studies:

   Previous research has shown a reduction of Wexner's incontinence scores by 5 points (SD=8) with pelvic floor rehabilitation (PFR) treatment (6-9).

   Study Design:

   The study was designed with a significance level (alpha error or Type I error) set at 0.05 and a power of the test (beta error or Type II error) at 0.20. A total of 64 patients were initially calculated to be necessary to detect a statistically significant difference between treatment groups.

   Sample Size Calculation:

   Considering an anticipated drop-out rate of 20%, the total sample size required for the study was adjusted to 77 patients.

   Plan for Missing Data

   Procedures will be in place to address missing data, including how to handle variables reported as missing or inconsistent. We shall evaluate the extent of missing data for each variable and use appropriate methods for handling missing data such as imputation techniques or sensitivity analyses.

   Statistical Analysis Plan:

   Study Design

   The study involves a randomized controlled trial (RCT) where patients undergoing Sphincter sparing-rectal cancer surgery are randomized into two groups:

   Standard Group: Receives standard post-operative care. PFR Group: Receives pelvic floor physiotherapy in addition to standard care. Outcome Measures

   The following continuous variables will be measured before starting the intervention and after 3 months:

   Wexner's Scores: Assessing fecal incontinence severity. LARS Scores (Low Anterior Resection Syndrome): Assessing bowel dysfunction. EORTC CR 29 Scores (European Organisation for Research and Treatment of Cancer Colorectal Cancer Module): Assessing quality of life related to colorectal cancer.

   Statistical Hypotheses

   Within-Group Comparison:

   Null Hypothesis (H0): There is no significant difference in mean scores (Wexner's, LARS, EORTC CR 29) before and after intervention within each group (Standard and PFR).

   Between-Group Comparison:

   Null Hypothesis (H0): There is no significant difference in the change in mean scores (Wexner's, LARS, EORTC CR 29) from before to after intervention between the Standard and PFR groups.

   Statistical Methods

   Descriptive Statistics:

   Mean and standard deviation (SD) for continuous variables (Wexner's, LARS, EORTC CR 29 scores) at baseline and after 3 months in each group.

   Within-Group Analysis:

   Paired t-tests or Wilcoxon signed-rank tests (depending on normality) to compare mean scores before and after intervention within each group (Standard and PFR).

   Between-Group Analysis:

   Independent samples t-tests or Mann-Whitney U tests (depending on normality) to compare the change in mean scores (after - before) between the Standard and PFR groups.

   Adjustments:

   Adjustments for potential confounding factors such as age, gender, and baseline scores using analysis of covariance (ANCOVA) if necessary.

   Effect Size:

   Calculate effect sizes (e.g., Cohen's d for t-tests, r for Mann-Whitney U tests) to quantify the magnitude of differences observed.

   Statistical Significance:

   We shall set the significance level (alpha) at 0.05 to determine statistical significance.

   Software

   Utilize statistical software (SPSS) for data analysis. Reporting

   We shall present results with confidence intervals and p-values, providing clear interpretations of findings in relation to clinical significance and study objectives.

   This detailed description outlines the comprehensive approach taken to ensure the study's rigor and reliability, aiming to fill significant gaps in current knowledge about effective aftercare for rectal cancer patients.

Eligibility criteria: 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

Primary outcomes:
measure: WEXNER INCONTINENCE SCORE
timeFrame: 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:
measure: Low Anterior Resection Syndrome score (LARS)
timeFrame: 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.
measure: Quality of life measure QORTC CR 29
timeFrame: 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.
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: GEM Hospital & Research Center
state: Tamil Nadu
Study officials:
affiliation: GEM Coimbatore
name: Harshavardhana H P, MS DrNB (IP)
role: PRINCIPAL_INVESTIGATOR
affiliation: GEM Coimbatore
name: RAJAPANDIAN S, DNB FRCS(Ed)
role: STUDY_DIRECTOR
affiliation: GEM Coimbatore
name: PALANIVELU C, MS Mch FRCS
role: STUDY_CHAIR
affiliation: GEM Coimbatore
name: HARISH KAKKILAYA, MS FACRSI
role: STUDY_DIRECTOR
affiliation: GEM Coimbatore
name: SHANKAR B, MS DrNB FRCS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.