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

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ClinicalTrials.gov Identifier: NCT02728427
Recruitment Status : Unknown
Verified April 2018 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : April 5, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
Fujian Cancer Hospital
Fujian Provincial Hospital
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Surgery Device: Suprapubic catheterization using central venous catheter(CVC-2 7F) Device: Transurethral catheterization using Foley catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
Study Start Date : April 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Suprapubic Catheterization
Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group.
 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.
Other Name: SPCCVC
Active Comparator: Transurethral Catheterization
Transurethral catheterization using Foley catheter will be performed for patients in this group.
 Device: 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.
Other Name: TUC


Outcome Measures
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Primary Outcome Measures :
  1. Catherization time [ Time Frame: 6 days ]

Secondary Outcome Measures :
  1. Number of catheterization [ Time Frame: 30 days ]
  2. Catheter-Associated Urinary Tract Infection [ Time Frame: 30 days ]
  3. Pain score [ Time Frame: 5 days ]
    Postoperative pain is recorded using the visual analog scale (VAS) pain score tool from the surgery day to the fifth day after surgery.

  4. International Prostatic Symptom Score [ Time Frame: 30 days ]
    The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery.

  5. Time to first ambulation [ Time Frame: 7 days ]
  6. Duration of hospital stay [ Time Frame: 30 days ]
  7. Urinary extravasation [ Time Frame: 30 days ]
  8. Hematuria [ Time Frame: 30 days ]
  9. Catheter obstruction [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02728427


Contacts
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Contact: Guoxin Li, M.D., Ph.D. +86-138-0277-1450 gzliguoxin@163.com
Contact: jun Yan, M.D., Ph.D. +86-138-2506-6546 yanjunfudan@163.com

Locations
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China, Fujian
Fujian Provincial Hospital Recruiting
Fuzhou, Fujian, China, 350-001
Contact: Fangqin Xue, M.D.    +86-137-9995-9360    xuefangqingsl@sina.com   
Principal Investigator: fangqin xue, M.D.         
Fujian Provincial cancer Hospital Recruiting
Fuzhou, Fujian, China, 350-014
Contact: Weidong Zang, M.D.    +86-13805066578    894434459@qq.com   
Contact: Chunkang Yang, M.D.    +86-13509333116      
China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510-515
Contact: Guoxin Li, M.D., Ph.D.    +86-138-0277-1450    gzliguoxin@163.com   
Contact: Jun Yan, M.D., Ph.D.    +86-138-2506-6546    yanjunfudan@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Fujian Cancer Hospital
Fujian Provincial Hospital
Investigators
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Principal Investigator: Guoxin Li, M.D., Ph.D. Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
More Information
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Additional Information:

Publications:

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02728427    
Other Study ID Numbers: SPCCVC-TUC
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nanfang Hospital of Southern Medical University:
Suprapubic Catheterization
Transurethral Catheterization
Rectal Cancer
Laparoscopic Surgery
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases