Clinical trial NCT04134104: Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy
Official title: Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Dysfunction
Bladder Dysfunction
Sexual Dysfunction
Colorectal Surgery
Lead sponsor: National Academy of Medical Sciences, Nepal
Sponsor class: OTHER_GOV
First posted: 2019-10-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Bowel Dysfunction
timeFrame: 6 months
measure: Bladder Dysfunction
timeFrame: 6 months
measure: Sexual Dysfunction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bir Hospital
name: Nabin Pokharel, MCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Bir Hospital
name: Gaurav Katwal, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Bir Hospital
name: Subodh K Adhikari, MS
role: STUDY_DIRECTOR
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