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.

• 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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Bowel; Functional Syndrome
• Intervention / Treatment: Radiation: chemoradiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Ahmad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: radiation group; Those are patient with rectal cancer who underwent preoperative neoadjuvant chemo radiotherapy before surgery.	Radiation: chemoradiotherapy; exposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery; Other Names: neoadjuvant chemoradiotherapy
Active Comparator: non radiation group; Those are patient with rectal cancer who did not receive preoperative neoadjuvant chemo radiotherapy before surgery.	Radiation: chemoradiotherapy; exposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery; Other Names: neoadjuvant chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Rectal cancer; Neoadjuvant therapy; Sphincter preserving surgery; ow anterior resection syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Irritable Bowel Syndrome; Rectal Neoplasms
• Other Study ID Numbers: 4-2019-1098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No