Back to resultsLong Term Bowel Function Following Rectal Cancer Surgery
Primary Purpose
Bowel; Functional Syndrome, Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
chemoradiotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Bowel; Functional Syndrome focused on measuring Rectal cancer, Sphincter preserving surgery, Neoadjuvant therapy, ow anterior resection syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes,
- Aged between 18 and 75 years,
- Patients with mid and upper rectal cancer (6-15) cm from the anal verge(AV) with or without preoperative chemo radiotherapy.
- Patients who underwent low anterior resection(LAR).
- Patients who were followed up with at least two outpatient visits for bowel function assessment.
Exclusion Criteria:
- Patients with recurrent rectal tumors,
- Surgically unfit patients,
- Patients with tumors infiltrating the puborectalis muscle or external sphincter.
- Patients with preoperative fecal incontinence.
- Patients who were followed up only once in the outpatient clinic.
- Patients with lower rectal cancer less than 6cm from AV,
- Patients who underwent abdominoperineal resection(APR) or intersphincteric resection(ISR).
Sites / Locations
- Ahmad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
radiation group
non radiation group
Arm Description
Those are patient with rectal cancer who underwent preoperative neoadjuvant chemo radiotherapy before surgery.
Those are patient with rectal cancer who did not receive preoperative neoadjuvant chemo radiotherapy before surgery.
Outcomes
Primary Outcome Measures
bowel function
During follow-up of the patients in the outpatient clinic, a designated nurse interviewed the patients using bowel function assessment questionnaires at different time intervals between November 2015-when bowel function assessment was started using MSKCC score-and July 2019. Each patient was interviewed at least twice.
The Memorial Sloan Kettering Cancer Center (MSKCC) questionnaire was used. The MSKCC score questionnaire contains 18 questions divided into three subscales: the frequency subscale with six items, dietary subscale with four items, and urgency/soilage subscale with four items, with four additional single items. Each subscale is scored by adding the scores of each item, and the global score is the sum of all subscale scores. Finally, the total score is calculated by summing the global score and the scores for the four single items with the maximum score of 90. The higher the score the better the function.
Secondary Outcome Measures
fecal incontinence
During follow-up of the patients in the outpatient clinic, a designated nurse interviewed the patients using fecal incontinence assessment questionnaire at different time intervals between November 2015-when fecal incontinence assessment was started using Wexner score-and July 2019. Each patient was interviewed at least twice.
The Wexner questionnaire was used. Wexner score questionnaire comprises five questions regarding solid, liquid, and gas incontinence; the use of a pad; and lifestyle alterations on a scale of 0-20 (0: no incontinence; 20: complete incontinence). The lower the score, the better the continence.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05339763
Brief Title
Long Term Bowel Function Following Rectal Cancer Surgery
Official Title
Long Term Bowel Functional Outcomes Following Anal Sphincter Preserving Surgery for Rectal Cancer: A Single Center Longitudinal Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
February 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this longitudinal study, 171 patients were evaluated and compared based on the radiation therapy they received.
Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.
Detailed Description
Background Despite advances in the neoadjuvant chemoradiation therapy and anal sphincter-preserving surgeries for rectal cancer, bowel dysfunction is still unavoidable which negatively affect the patients' quality of life. In this longitudinal study, The aim of this study was to investigate the changes in bowel function with follow up time and the effect of the neoadjuvant chemo radiotherapy on bowel function following low anterior resection for rectal cancer.
Materials and methods In this study, 171 patients with rectal cancer who underwent low anterior resection between 2012 and 2018 were included. Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel; Functional Syndrome, Rectal Cancer
Keywords
Rectal cancer, Sphincter preserving surgery, Neoadjuvant therapy, ow anterior resection syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
radiation group
Arm Type
Active Comparator
Arm Description
Those are patient with rectal cancer who underwent preoperative neoadjuvant chemo radiotherapy before surgery.
Arm Title
non radiation group
Arm Type
Active Comparator
Arm Description
Those are patient with rectal cancer who did not receive preoperative neoadjuvant chemo radiotherapy before surgery.
Intervention Type
Radiation
Intervention Name(s)
chemoradiotherapy
Other Intervention Name(s)
neoadjuvant chemoradiotherapy
Intervention Description
exposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery
Primary Outcome Measure Information:
Title
bowel function
Description
During follow-up of the patients in the outpatient clinic, a designated nurse interviewed the patients using bowel function assessment questionnaires at different time intervals between November 2015-when bowel function assessment was started using MSKCC score-and July 2019. Each patient was interviewed at least twice.
The Memorial Sloan Kettering Cancer Center (MSKCC) questionnaire was used. The MSKCC score questionnaire contains 18 questions divided into three subscales: the frequency subscale with six items, dietary subscale with four items, and urgency/soilage subscale with four items, with four additional single items. Each subscale is scored by adding the scores of each item, and the global score is the sum of all subscale scores. Finally, the total score is calculated by summing the global score and the scores for the four single items with the maximum score of 90. The higher the score the better the function.
Time Frame
6 months-24 months
Secondary Outcome Measure Information:
Title
fecal incontinence
Description
During follow-up of the patients in the outpatient clinic, a designated nurse interviewed the patients using fecal incontinence assessment questionnaire at different time intervals between November 2015-when fecal incontinence assessment was started using Wexner score-and July 2019. Each patient was interviewed at least twice.
The Wexner questionnaire was used. Wexner score questionnaire comprises five questions regarding solid, liquid, and gas incontinence; the use of a pad; and lifestyle alterations on a scale of 0-20 (0: no incontinence; 20: complete incontinence). The lower the score, the better the continence.
Time Frame
6 months-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes,
Aged between 18 and 75 years,
Patients with mid and upper rectal cancer (6-15) cm from the anal verge(AV) with or without preoperative chemo radiotherapy.
Patients who underwent low anterior resection(LAR).
Patients who were followed up with at least two outpatient visits for bowel function assessment.
Exclusion Criteria:
Patients with recurrent rectal tumors,
Surgically unfit patients,
Patients with tumors infiltrating the puborectalis muscle or external sphincter.
Patients with preoperative fecal incontinence.
Patients who were followed up only once in the outpatient clinic.
Patients with lower rectal cancer less than 6cm from AV,
Patients who underwent abdominoperineal resection(APR) or intersphincteric resection(ISR).
Facility Information:
Facility Name
Ahmad
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Long Term Bowel Function Following Rectal Cancer Surgery
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