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Completed

NCT Number: NCT05339763

Long Term Bowel Function Following Rectal Cancer Surgery

* 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.

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Key information

Conditions

Bowel; Functional Syndrome Colonic Diseases Colonic Diseases, Functional Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Irritable Bowel Syndrome Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmad

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Chemoradiotherapy

Radiation

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

Other names: neoadjuvant chemoradiotherapy

Primary outcomes

  1. bowel function

    Time frame: 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 outcomes

  1. fecal incontinence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 21, 2022
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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