Incidence of The Bowel, Bladder, and Sexual Dysfunction Following Surgery for Colorectal Malignancy
NCT ID: NCT04134104
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
38 participants
OBSERVATIONAL
2014-12-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Database for Colonic or Rectal Resection Surgery Patients
NCT04704817
Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
NCT06050447
Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery
NCT00451165
QoL of Colorectal Cancer Patients and Spouses
NCT04744792
Appendectomy and Colorectal Cancer
NCT06091137
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Surgery for Colorectal malignant diseases either LAR or APR
Patients following LAR or APR were observed for the Bowel, Bladder, and Sexual Dysfunction
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgery for Colorectal malignant diseases either LAR or APR
Patients following LAR or APR were observed for the Bowel, Bladder, and Sexual Dysfunction
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Lost to follow up,
3. Benign disease,
4. Patients who did not undergo neoadjuvant chemoradiotherapy, and
5. Patients who underwent trans-anal excision.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Academy of Medical Sciences, Nepal
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nabin Pokharel
Assistant Professor/ Senior Medical Officer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nabin Pokharel, MCh
Role: PRINCIPAL_INVESTIGATOR
Bir Hospital
Gaurav Katwal, MS
Role: PRINCIPAL_INVESTIGATOR
Bir Hospital
Subodh K Adhikari, MS
Role: STUDY_DIRECTOR
Bir Hospital
References
Explore related publications, articles, or registry entries linked to this study.
Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.
Hawkins AT, Albutt K, Wise PE, Alavi K, Sudan R, Kaiser AM, Bordeianou L; Continuing Education Committee of the SSAT. Abdominoperineal Resection for Rectal Cancer in the Twenty-First Century: Indications, Techniques, and Outcomes. J Gastrointest Surg. 2018 Aug;22(8):1477-1487. doi: 10.1007/s11605-018-3750-9. Epub 2018 Apr 16.
Yeom SS, Park IJ, Jung SW, Oh SH, Lee JL, Yoon YS, Kim CW, Lim SB, Kim N, Yu CS, Kim JC. Outcomes of patients with abdominoperineal resection (APR) and low anterior resection (LAR) who had very low rectal cancer. Medicine (Baltimore). 2017 Oct;96(43):e8249. doi: 10.1097/MD.0000000000008249.
Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2.
Juul T, Ahlberg M, Biondo S, Emmertsen KJ, Espin E, Jimenez LM, Matzel KE, Palmer G, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. International validation of the low anterior resection syndrome score. Ann Surg. 2014 Apr;259(4):728-34. doi: 10.1097/SLA.0b013e31828fac0b.
Adam JP, Denost Q, Capdepont M, van Geluwe B, Rullier E. Prospective and Longitudinal Study of Urogenital Dysfunction After Proctectomy for Rectal Cancer. Dis Colon Rectum. 2016 Sep;59(9):822-30. doi: 10.1097/DCR.0000000000000652.
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
Bregendahl S, Emmertsen KJ, Lous J, Laurberg S. Bowel dysfunction after low anterior resection with and without neoadjuvant therapy for rectal cancer: a population-based cross-sectional study. Colorectal Dis. 2013 Sep;15(9):1130-9. doi: 10.1111/codi.12244.
Keane C, Wells C, O'Grady G, Bissett IP. Defining low anterior resection syndrome: a systematic review of the literature. Colorectal Dis. 2017 Aug;19(8):713-722. doi: 10.1111/codi.13767.
Kupsch J, Jackisch T, Matzel KE, Zimmer J, Schreiber A, Sims A, Witzigmann H, Stelzner S. Outcome of bowel function following anterior resection for rectal cancer-an analysis using the low anterior resection syndrome (LARS) score. Int J Colorectal Dis. 2018 Jun;33(6):787-798. doi: 10.1007/s00384-018-3006-x. Epub 2018 Mar 15.
Lange MM, Maas CP, Marijnen CA, Wiggers T, Rutten HJ, Kranenbarg EK, van de Velde CJ; Cooperative Clinical Investigators of the Dutch Total Mesorectal Excision Trial. Urinary dysfunction after rectal cancer treatment is mainly caused by surgery. Br J Surg. 2008 Aug;95(8):1020-8. doi: 10.1002/bjs.6126.
Doeksen A, Gooszen JA, van Duijvendijk P, Tanis PJ, Bakx R, Slors JF, van Lanschot JJ. Sexual and urinary functioning after rectal surgery: a prospective comparative study with a median follow-up of 8.5 years. Int J Colorectal Dis. 2011 Dec;26(12):1549-57. doi: 10.1007/s00384-011-1288-3. Epub 2011 Sep 16.
Junginger T, Kneist W, Heintz A. Influence of identification and preservation of pelvic autonomic nerves in rectal cancer surgery on bladder dysfunction after total mesorectal excision. Dis Colon Rectum. 2003 May;46(5):621-8. doi: 10.1007/s10350-004-6621-2.
Hendren SK, O'Connor BI, Liu M, Asano T, Cohen Z, Swallow CJ, Macrae HM, Gryfe R, McLeod RS. Prevalence of male and female sexual dysfunction is high following surgery for rectal cancer. Ann Surg. 2005 Aug;242(2):212-23. doi: 10.1097/01.sla.0000171299.43954.ce.
Bruheim K, Guren MG, Dahl AA, Skovlund E, Balteskard L, Carlsen E, Fossa SD, Tveit KM. Sexual function in males after radiotherapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1012-7. doi: 10.1016/j.ijrobp.2009.03.075. Epub 2009 Oct 31.
Vironen JH, Kairaluoma M, Aalto AM, Kellokumpu IH. Impact of functional results on quality of life after rectal cancer surgery. Dis Colon Rectum. 2006 May;49(5):568-78. doi: 10.1007/s10350-006-0513-6.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1145
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.