Long Term Bowel Function Following Rectal Cancer Surgery

NCT ID: NCT05339763

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-12
• Study Completion Date: 2020-02-25

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.

Conditions

Bowel; Functional Syndrome; Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

radiation group

Those are patient with rectal cancer who underwent preoperative neoadjuvant chemo radiotherapy before surgery.

Group Type: ACTIVE_COMPARATOR

chemoradiotherapy

Intervention Type: RADIATION

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

non radiation group

Those are patient with rectal cancer who did not receive preoperative neoadjuvant chemo radiotherapy before surgery.

Group Type: ACTIVE_COMPARATOR

chemoradiotherapy

Intervention Type: RADIATION

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

Interventions

chemoradiotherapy

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

Intervention Type: RADIATION

Other Intervention Names

neoadjuvant chemoradiotherapy

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Sakr

consultant and lecturer of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmad

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

4-2019-1098

Identifier Type: -

Identifier Source: org_study_id