Digestive System Diseases

All Conditions

Intestinal Diseases

Gastrointestinal Diseases

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.

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

Surgery for Colorectal malignant diseases either LAR or APR

Nabin Pokharel, MCh

Gaurav Katwal, MS

Subodh K Adhikari, MS

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.

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.

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

If other researchers are interested in the IPD of our research. They can ask us through our email. We will provide the IPD.

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.

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.

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.

National Academy of Medical Sciences, Nepal

Assistant Professor/ Senior Medical Officer

Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS

Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS

A noninvasive urodynamics is a simple test used to evaluate urinary flow.

Non-invasive Urodynamic Test (niUDS)

Urine proteomics is a powerful platform to identify urinary excreted proteins and peptides in different stages of disease or therapy and to determine their quantity, functions, and interaction.

Urinary proteomic screen

The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children.

Dysfunctional Voiding Symptom Score Survey (DVSS)

Gemma Beltran

Nicholas Cost, MD

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition.

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition. The global hypothesis is that childhood cancer survivors with prior exposure to systemic vincristine (VCR) and/or doxorubicin (DOX) report an increased incidence of bladder dysfunction (BD) symptoms on the Dysfunctional Voiding Symptom Score (DVSS) survey. We expect to observe differences in non-invasive urodynamic (niUDS) testing between childhood cancer survivors with BD symptoms on the DVSS versus those without BD symptoms on DVSS. We also expect to observe statistically significant differences in the urinary levels of known urinary biomarkers of BD (NGF, ATP and BDNF) of patients with evidence of BD compared to those without BD on the DVSS. We also expect to observe rational differences in the urinary proteome of patients between those with and without BD.

Study groups and sub-groups will be assigned by gender

Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

Patient Data will be shared after written request to study PI and after approval by local IRB and study committee

a. Patterns will be scored by blinded reviewers b. Will calculate an Inter-rater Kappa correlation co-efficient i. Utilize consensus review for discrepancies between reviewers and between the patient's 1st/2nd niUDS for the final assignment ii. Will calculate an intra-test reliability (compare correlation between 1st and 2nd patter) c. Chi-square test to compare proportions of non-normal vs. normal pattern type i. Group 1a vs. 2a ii. Group 1b vs. 2b d. Sample Size Calculation: Based on published data of niUDS patterns in children with normal bladder function, we expect 15% of those children in Group 2 to have non-normal niUDS patterns. We hypothesize that 40% of children in Group 1 to have non-normal niUDS patterns. 38 subjects in each gender sub-group provide 80% power to detect this 25% difference with an one-sided chi-square test with an alpha of 0.05.

a. Will use an "average PVR" between the 1st/2nd niUDS for the analysis b. Chi-square test to compare proportions of elevated PVR i. Group 1a vs. 2a ii. Group 1b vs. 2b c. Sample Size Calculation: Based on published data of PVR in children with normal bladder function, we expect 1.5% of those children in Group 2 to have elevated PVR. We hypothesize that 25% of children in Group 1 to have an elevated PVR. 21 subjects in each gender sub-group provide 80% power to detect this 23.5% difference with an one-sided chi-square test with an alpha of 0.05.

a. Will use the average of the two Qmax between the 1st/2nd flow rate for the analysis b. Two group t-test for comparing continuous variables (Qmax) i. Group 1a vs. 2a ii. Group 1b vs. 2b c. Sample Size Calculation: 38 subjects in Group 1a and 2a provide 80% power to detect an effect size of 0.7 (mean difference divided by the common standard deviation) using a 2-sided two-group test with an alpha of 0.05. if the outcome is not normally distributed, transformation will be carried out so the distribution will be approximately normal. This power calculation also applies to the comparison between Group 1b vs 2b

a. Will use the average of the two Qavg between the 1st/2nd flow rate for the analysis b. Two group ttest for comparing continuous variables (Qavg) i. Group 1a vs. 2a ii. Group 1b vs. 2b c. See the power calculation in 3c.

1. Compare urinary biomarker levels between groups i. ATP, BDNF, NGF ii. Two-group t-test for comparing continuous variables

1. Group 1 vs. 2
2. Sub-analysis

   1. Group 1a vs. 2a
   2. Group 1b vs. 2b The sample size calculation in 1d can apply to each biomarker. Based on published data in other populations with BD, for NGF, ATP and BDNF, we hypothesize to detect a difference of these urinary biomarkers 2x higher in Group 2 (Elevated DVSS scores) vs. Group 1 (Normal DVSS scores).

A mixed effects model will be used to estimate and compare a biomarker expression between the two groups by incorporating the individual measurements on each subject into the model, where gender and group assignment will be the predictor. Interaction term between group and gender will be considered to study the effect modification by gender on a biomarker if possible.

National Cancer Institute (NCI)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Children's Hospital Colorado

University of Colorado, Denver

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Removal of urinary catheter on the first day after radical surgery

REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY

Currently, the treatment of cervical cancer in early stages is performed with a radical surgery called Radical Hysterectomy with Pelvic Lymphadenectomy. This surgery, when indicated correctly, in early stages of this disease, has a cure rate of approximately 90% at 5 years, compared to the same Pelvic Radiotherapy. However, it is known that most patients with early stage cervical cancer are young (average age 45) and treating these patients with radiotherapy would have a loss of hormonal function by damage to the ovaries and damage in sexual function by radiotherapy effects in the vagina. Furthermore, if the patient has a pelvic recurrence, the option of radiotherapy treatment could not be offered. Due to the factors listed above, nowadays, in young patients with good clinical conditions and tumors in early stages, radical surgery is a good option. In this radical surgery there is a need for removal of the parametrium, and different degrees of pelvic denervation may occur causing damage of urinary function.Currently, there is no consensus about the correct moment of catheter removal and evaluation of urinary function using the residual urine test. While in some services the urinary catheter is removed on day 1 postoperatively, in others it is removed on the 14th day postoperatively. For these reasons, this study aims to compare the early catheter removal (day 1 postoperatively) versus standard in the investigator's service (7 days postoperatively) withdrawal. If this study detect that the patients may remove the urinary catheter on day 1 postoperatively, much less cost, discomfort, pain and comorbidities associated with the use of indwelling catheter for prolonged periods occur, such as urinary tract infection, use of antibiotics and even hospitalization for this reason.

Removal of Urinary Catheter After Radical Surgery

Evaluation of Early Removal of Urinary Catheter After Radical Surgery for Cervical Cancer Treatment

Measure the urinary retention after the surgery passing an urinary catheter after patient voiding to check the urinary residual

Barretos Cancer Hospital

Principal Investigator

All Drugs and Chemicals

Bethanechol

Muscarinic Agonists

Cholinergic Agents

Neurotransmitter Agents

* Ucholine(Bethanechol chloride, 10 mg) 2 tablets oral tid, ac Start on 3rd - 5th postoperative day
* In bethanechol chloride arm arm should be vital signs were monitored every 30 minute on first hour then every 4 hours on first day. Any adverse event were recorded.
* Remove urethral catheter on 5thpostoperative day. Void volume and postvoid residual urine were record. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative

* Early bladder training Start on 3rd - 5th postoperative day
* Remove urethral catheter on 5th postoperative day. Void volume and postvoid residual urine were recorded. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative

* Early bladder training and Ucholine(Bethanechol chloride, 10 mg) 2 tablets oral tid, ac Start on 3rd - 5th postoperative day
* should be vital signs were monitored every 30 minute on first hour then every 4 hours on first day. Any adverse event were recorded.
* Remove urethral catheter on 5th postoperative day. Void volume and postvoid residual urine were recorded. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative

-Remove urethral catheter on 5th postoperative day. Void volume and postvoid residual urine were recorded. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative

bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day

bethanechol chloride

early bladder training start on 3rd - 5thpostoperative day

early bladder training

bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day

early bladder training and bethanechol chloride

no bethanechol chloride and no early bladder training

no early bladder training and no bethanechol chloride

Compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.

Cervical cancer is the third most common cancer in women worldwide, after breast and colorectal cancer. Molecular biology has firmly established a causal relationship between persistent infection with high risk human papilloma virus (HPV) genotypes and cervical cancer.

Cervical cancer stage IB1 and selected IIA 1 lesions without extensive vaginal involvement can be treated with either RH and pelvic lymph node dissection (PLD) or primary chemoradiation.

Bladder dysfunction is the most common complication after radical hysterectomy. The incidence is approximate 10-80 %. Management of bladder dysfunction is continuous urethral catheterization or clean intermittent self-catheterization. Prolonged urethral catheterization may increase the risk of urinary tract infection.

Early postoperative bladder training that consist of a scheduled clamping trans-urethral catheter every 3 h and unclamping trans-urethral catheter 15 min during the entire day.

Bethanechol chloride is a cholinergic drug and may enhance the detrusor muscle contraction, resulting in higher maximum flow rate, and lower postvoid residual urine.

This study was conducted to compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.

Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy	NCT04134104	Bowel Dysfuncti... Bladder Dysfunc... Sexual Dysfunct... Colorectal Surg...	Surgery for Col...	18 Years - 75 Years	National Academy of Medical Sciences, Nepal
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children	NCT04993859	Survivors of Ch... Bladder Dysfunc...	Non-invasive Ur... Urinary proteom... Dysfunctional V...	5 Years - 10 Years	University of Colorado, Denver
Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy	NCT04134104	Bowel Dysfuncti... Bladder Dysfunc... Sexual Dysfunct... Colorectal Surg...	Surgery for Col...	18 Years - 75 Years	National Academy of Medical Sciences, Nepal
Removal of Urinary Catheter After Radical Surgery	NCT03570593	Cervical Cancer Radical Hystere... Bladder Dysfunc...	REMOVAL OF URIN...	-	Barretos Cancer Hospital
Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy	NCT04134104	Bowel Dysfuncti... Bladder Dysfunc... Sexual Dysfunct... Colorectal Surg...	Surgery for Col...	18 Years - 75 Years	National Academy of Medical Sciences, Nepal
Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA	NCT02910596	Bladder Dysfunc...	bethanechol chl... early bladder t... early bladder t... no early bladde...	20 Years - 65 Years	Rajavithi Hospital
Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy	NCT04134104	Bowel Dysfuncti... Bladder Dysfunc... Sexual Dysfunct... Colorectal Surg...	Surgery for Col...	18 Years - 75 Years	National Academy of Medical Sciences, Nepal

Spots Global Cancer Trial Database for bladder dysfunction