Long Term Bowel Function Following Rectal Cancer Surgery

Not Applicable

Completed

• Conditions: Rectal Cancer; Bowel; Functional Syndrome
• Interventions: Radiation: chemoradiotherapy

• Registration Number: NCT05339763
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-12
• Primary Completion: 2019-12-10
• Study Completion: 2020-02-25
• Study First Submitted: 2022-03-31
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-21
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiation group	chemoradiotherapy	Those are patient with rectal cancer who underwent preoperative neoadjuvant chemo radiotherapy before surgery.
non radiation group	chemoradiotherapy	Those are patient with rectal cancer who did not receive preoperative neoadjuvant chemo radiotherapy before surgery.

Primary Outcome Measures

Name	Time	Method
bowel function	6 months-24 months	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

Name	Time	Method
fecal incontinence	6 months-24 months	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.

Trial Locations

Locations (1)

Ahmad; 🇪🇬 Mansoura, Egypt