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

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ClinicalTrials.gov Identifier: NCT04134104
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nabin Pokharel, National Academy of Medical Sciences, Nepal

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.

Condition or disease Intervention/treatment
Bowel Dysfunction Bladder Dysfunction Sexual Dysfunction Colorectal Surgery Procedure: Surgery for Colorectal malignant diseases either LAR or APR

Detailed Description:

It was a cross-sectional study at Bir Hospital and the duration of the study was from December 2014 to December 2017. Here, all the patients who underwent LAR and APR following neoadjuvant chemoradiotherapy were included. And, all the patients with recurrence after surgery, lost to follow up, benign disease, who did not undergo neoadjuvant chemoradiotherapy, and who underwent trans-anal excision were excluded from the study. In our study, the independent variable will be the type of surgery done for colorectal malignant disease. And the dependent variables will be the postoperative complications in the form of immediate and delayed complications. Immediate could be infectious or non-infectious complications and delayed (long term) complications could be bowel, bladder, and sexual dysfunction respectively.

Data collection was done using structured Performa that included all the demographic parameters, examination findings which included the data regarding neoadjuvant chemoradiotherapy and type of surgery (LAR and APR) were included. The laboratory parameters were also included. All the operative and post-operative details were included regarding bowel, bladder, and sexual dysfunction. And validated tools were used to calculate and analyze data.

LARS Score Questionnaire: The aim of this questionnaire was to assess the bowel function using a validated questionnaire.6 The LARS 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.

IPSS Questionnaire: Assessment of bladder dysfunction was assessed by the validated questionnaire of International Prostatic Symptoms Score (IPSS) for bladder dysfunction.8 For the evaluation of preoperative and postoperative bladder function, a urologic history and residual urine volume measurements by ultrasound were done.

Sexual Function Evaluation: In the early period after surgery sexual function was measured using the validated questionnaire - the International Index of Female Sexual Function (IFSF) for females and the International Index of Erectile Function (IIEF) for males. These tools helped to assess the impact of a specific treatment modality by evaluating different sexual function domains. Our study group was small, so we did not classify the groups into mild, moderate, and severe dysfunction groups. We did the overall long term assessment of the patients who came for the follow-up. These specific questionnaires were asked and the assessment was done for the overall dysfunctions.

Ethics: The study was approved by the institutional ethical committee- "IRB of NAMS, Bir Hospital" and written consent was obtained from all of the patients.

Statistics: All the data were entered in SPSS version 16 and then statistical analysis was done. Type of surgery, the status of neoadjuvant chemoradiotherapy, and the postoperative outcomes were studied respectively. Correlation and logistic regression statistic tools were used. A comprehensive literature search published in English was done until 2019 using Hinari, PubMed, and Cochrane Library.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 38 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy
Actual Study Start Date : December 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Group/Cohort Intervention/treatment
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
Patients following LAR or APR were observed for the Bowel, Bladder, and Sexual Dysfunction




Primary Outcome Measures :
  1. Bowel Dysfunction [ Time Frame: 6 months ]
    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.

  2. Bladder Dysfunction [ Time Frame: 6 months ]
    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.

  3. Sexual Dysfunction [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134104


Sponsors and Collaborators
National Academy of Medical Sciences, Nepal
Investigators
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Principal Investigator: Nabin Pokharel, MCh National Academy of Medical Sciences, Bir Hospital
Principal Investigator: Gaurav Katwal, MS National Academy of Medical Sciences, Bir Hospital
Study Director: Subodh K Adhikari, MS National Academy of Medical Sciences, Bir Hospital

Additional Information:
Publications:

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Responsible Party: Nabin Pokharel, Assistant Professor/ Senior Medical Officer, National Academy of Medical Sciences, Nepal
ClinicalTrials.gov Identifier: NCT04134104     History of Changes
Other Study ID Numbers: 1145
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If other researchers are interested in the IPD of our research. They can ask us through our email. We will provide the IPD.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: It can be provided any time if asked via email.
Access Criteria: The interested researcher should contact the corresponding author.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases