Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer

Surgery Clinical Trial

— MSSPC  

Official title:

Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02728427
• Other study ID #: SPCCVC-TUC
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: April 25, 2018
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Guoxin Li, M.D., Ph.D.
• Phone: +86-138-0277-1450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compared with traditional open proctectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some studies show that the rates of urinary tract infection, second catheterization, and urinary symptom are lower with suprapubic catheterization (SPC) than with transurethral catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.

Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC. Therefore, investigators perform this prospective randomized trial to compare SPC using CVC with TUC in laparoscopic surgery for rectal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years

• Pathological rectal carcinoma

• Male patients

• Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale

• ASA (American Society of Anesthesiology) score class I, II, or III

• Laparoscopic surgery for rectal cancer

• Written informed consent

Exclusion Criteria:

• Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer

• Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual

• Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function

• History of previous pelvic surgery

• Severe mental disease

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Surgery

Intervention

Device:
• Suprapubic catheterization using central venous catheter(CVC-2 7F)
Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients after laparoscopic surgery for rectal cancer.Suprapubic catheterization is inserted at the end of the procedure. It will be clamped depending on surgeon's specific instruction and removed if the urinary residual is less than 50 cc.
• Transurethral catheterization using Foley catheter
Traditional transurethral catheterization using Foley catheter will be performed for patients.The catheterization is removed on day 5 in patients without complication.

Locations

Country	Name	City	State
China	Fujian Provincial cancer Hospital	Fuzhou	Fujian
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Fujian Cancer Hospital, Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882. — View Citation

Bouchet-Doumenq C, Lefevre JH, Bennis M, Chafai N, Tiret E, Parc Y. Management of postoperative bladder emptying after proctectomy in men for rectal cancer. A retrospective study of 190 consecutive patients. Int J Colorectal Dis. 2016 Mar;31(3):511-8. doi: 10.1007/s00384-015-2471-8. Epub 2015 Dec 22. — View Citation

Jayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ. Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg. 2005 Sep;92(9):1124-32. — View Citation

Maurer CA, Z'Graggen K, Renzulli P, Schilling MK, Netzer P, Büchler MW. Total mesorectal excision preserves male genital function compared with conventional rectal cancer surgery. Br J Surg. 2001 Nov;88(11):1501-5. — View Citation

Perrin LC, Penfold C, McLeish A. A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery. Aust N Z J Surg. 1997 Aug;67(8):554-6. — View Citation

Ratnaval CD, Renwick P, Farouk R, Monson JR, Lee PW. Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery. Int J Colorectal Dis. 1996;11(4):177-9. — View Citation

Sethia KK, Selkon JB, Berry AR, Turner CM, Kettlewell MG, Gough MH. Prospective randomized controlled trial of urethral versus suprapubic catheterization. Br J Surg. 1987 Jul;74(7):624-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catherization time		6 days
Secondary	Number of catheterization		30 days
Secondary	Catheter-Associated Urinary Tract Infection		30 days
Secondary	Pain score	Postoperative pain is recorded using the visual analog scale (VAS) pain score tool from the surgery day to the fifth day after surgery.	5 days
Secondary	International Prostatic Symptom Score	The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery.	30 days
Secondary	Time to first ambulation		7 days
Secondary	Duration of hospital stay		30 days
Secondary	Urinary extravasation		30 days
Secondary	Hematuria		30 days
Secondary	Catheter obstruction		30 days

External Links

•   Chinese Anti-Cancer Association
•   Nanfang Hospital, China
•   Southern Medical University, China