Long Term Bowel Function Following Rectal Cancer Surgery

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339763
• Other study ID #: 4-2019-1098
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: April 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: February 25, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bowel; Functional Syndrome
• Irritable Bowel Syndrome
• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• chemoradiotherapy
exposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery

Locations

Country	Name	City	State
Egypt	Ahmad	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months-24 months
Secondary	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.	6 months-24 months