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Long Term Bowel Function Following Rectal Cancer Surgery

Long Term Bowel Functional Outcomes Following Anal Sphincter Preserving Surgery for Rectal Cancer: A Single Center Longitudinal Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05339763
Enrollment
171
Registered
2022-04-21
Start date
2019-08-12
Completion date
2020-02-25
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel; Functional Syndrome, Rectal Cancer

Keywords

Rectal cancer, Sphincter preserving surgery, Neoadjuvant therapy, ow anterior resection syndrome

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.

Interventions

RADIATIONchemoradiotherapy

exposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
bowel function6 months-24 monthsDuring 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

MeasureTime frameDescription
fecal incontinence6 months-24 monthsDuring 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026