Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy

NCT04134104 | Completed DMC

• 1 other identifier: 1145
• Study Type: observational
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal cancer is the second most common cancer by the site in Europe and the third most common cancer in the USA with high morbidity and mortality. Survival after the treatment has improved over the past few decades as a result of early diagnosis, radiotherapy, and advances in surgical techniques such as abdominoperineal resection (APR), low anterior resection (LAR) and total mesorectal excision (TME). These innovative surgeries are the current standard treatment for the mid and the low rectal cancers which avoids the permanent colostomy. It is very difficult to find out the incidence of the bowel, bladder and sexual dysfunction of patients either because they are embarrassed or because they do not relate their symptoms to rectal cancer treatment. This article reports the incidence of the bowel, bladder and sexual dysfunction following surgery for rectal cancer from the National Academy of Medical Sciences, Bir Hospital, a tertiary level hospital.

Conditions

Bowel Dysfunction; Bladder Dysfunction; Sexual Dysfunction; Colorectal Surgery

Outcome Measures

Primary Outcomes (3)

• Bowel Dysfunction

  Self reported urgency, fecal incontinence (either flatus or stool), difficulty in the evacuation. It is calculated using LARS Score Questionnaire which consists of five questions and can be used to generate an overall score that translates into no LARS (score 0-20), minor LARS (21-29), and major LARS (30-42) respectively.

  6 months

• Bladder Dysfunction

  Self reported Weak urinary stream, stress incontinence, difficulty in postponing urination, dysuria. Assessment of bladder dysfunction was done by the validated questionnaire of International Prostatic Symptoms Score (IPSS) for bladder dysfunction.

  6 months

• Sexual Dysfunction

  Self reported no sexual desire, unable to attain erection, unable to ejaculate, dyspareunia. The International Index of Female Sexual Function (IFSF) for females and the International Index of Erectile Function (IIEF) for males.

  6 months

Study Arms (1)

Bowel, Bladder, and Sexual Dysfunction group

Out of 38 patients included for surgery 12 were excluded due to poor follow up and those patients who underwent upfront surgery. Only 26 patients were included in the study. There were 20 (76.9%) males and 6 (23.1%) females respectively. The mean age of the patient was 43.577yrs (26-75) and mean BMI was 20.78. The number of patients that underwent LAR was 24 (92.30%) and those who underwent APR were 2( 7.6%) after neoadjuvant chemoradiotherapy respectively.

Procedure: Surgery for Colorectal malignant diseases either LAR or APR

Interventions

Surgery for Colorectal malignant diseases either LAR or APR PROCEDURE

Patients following LAR or APR were observed for the Bowel, Bladder, and Sexual Dysfunction

Bowel, Bladder, and Sexual Dysfunction group

Eligibility Criteria

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

Study Population

It was a cross-sectional study at Bir Hospital and the duration of the study was from December 2014 to December 2017. Out of 38 patients included for surgery 12 were excluded due to poor follow up and those patients who underwent upfront surgery. Only 26 patients were included in the study. There were 20 (76.9%) males and 6 (23.1%) females respectively. The mean age of the patient was 43.577yrs (26-75) and mean BMI was 20.78. The number of patients that underwent LAR was 24 (92.30%) and those who underwent APR were 2( 7.6%) after neoadjuvant chemoradiotherapy respectively. Immediate could be infectious or non-infectious complications and delayed (long term) complication could be bowel, bladder, and sexual dysfunction respectively.

You may qualify if:

• \) All the patients who underwent LAR and APR following neoadjuvant chemoradiotherapy.

You may not qualify if:

• All the patients with recurrence after surgery,
• Lost to follow up,
• Benign disease,
• Patients who did not undergo neoadjuvant chemoradiotherapy, and
• Patients who underwent trans-anal excision.

Sponsors & Collaborators

• National Academy of Medical Sciences, Nepal: lead

Related Publications (18)

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Related Links

• Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018
• A prospective study of sexual and urinary function before and after total mesorectal excision

MeSH Terms

Conditions

Intestinal Diseases; Sexual Dysfunction, Physiological

Interventions

Surgical Procedures, Operative; Low Density Lipoprotein Receptor-Related Protein-1

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

LDL-Receptor Related Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, LDL; Receptors, Lipoprotein; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Nabin Pokharel, MCh

  Bir Hospital

  PRINCIPAL INVESTIGATOR

• Gaurav Katwal, MS

  Bir Hospital

  PRINCIPAL INVESTIGATOR

• Subodh K Adhikari, MS

  Bir Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/ Senior Medical Officer

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: October 21, 2019
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It can be provided any time if asked via email.
• Access Criteria: The interested researcher should contact the corresponding author.