Long Term Bowel Function Following Rectal Cancer Surgery

NCT05339763 | Completed

• 1 other identifier: 4-2019-1098
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel; Functional Syndrome; Rectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• fecal incontinence

  6 months-24 months

Study Arms (2)

radiation group

ACTIVE COMPARATOR

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

Radiation: chemoradiotherapy

non radiation group

ACTIVE COMPARATOR

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

Radiation: chemoradiotherapy

Interventions

chemoradiotherapy RADIATION

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

Also known as: neoadjuvant chemoradiotherapy

non radiation group; radiation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ahmad

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Rectal Neoplasms

Interventions

Chemoradiotherapy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant and lecturer of general surgery

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 21, 2022
• Study Start: August 12, 2019
• Primary Completion: December 10, 2019
• Study Completion: February 25, 2020
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

EG (1)