Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524362
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum - A Randomised Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum - A Randomised Controlled Trial PERECARE TRIAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERECARE
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 12
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
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 12
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 Wexners score LARS score EORTC CR 29 score taken before the start of the study
Follow-up Participants will be followed for three months and Wexners 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 Wexners incontinence scores by 5 points SD8 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 005 and a power of the test beta error or Type II error at 020 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
Wexners 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 Wexners 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 Wexners 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 Wexners 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 eg Cohens 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 005 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 studys rigor and reliability aiming to fill significant gaps in current knowledge about effective aftercare for rectal cancer patients
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 Wexners score LARS score EORTC CR 29 score taken before the start of the study
Follow-up Participants will be followed for three months and Wexners 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 Wexners incontinence scores by 5 points SD8 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 005 and a power of the test beta error or Type II error at 020 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
Wexners 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 Wexners 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 Wexners 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 Wexners 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 eg Cohens 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 005 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 studys rigor and reliability aiming to fill significant gaps in current knowledge about effective aftercare for rectal cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None