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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Cancer, Surgery

Intervention / Treatment
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* Device: Suprapubic catheterization using central venous catheter(CVC-2 7F)
* Device: Transurethral catheterization using Foley catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprapubic Catheterization<br>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)<br>* 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.<br>* Other names: SPCCVC;|
| Active Comparator: Transurethral Catheterization<br>Transurethral catheterization using Foley catheter will be performed for patients in this group. | Device: Transurethral catheterization using Foley catheter<br>* Traditional transurethral catheterization using Foley catheter will be performed for patients.The catheterization is removed on day 5 in patients without complication.<br>* Other names: TUC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catherization time |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of catheterization |  | 30 days | 
| Catheter-Associated Urinary Tract Infection |  | 30 days | 
| 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 | 
| International Prostatic Symptom Score | The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery. | 30 days | 
| Time to first ambulation |  | 7 days | 
| Duration of hospital stay |  | 30 days | 
| Urinary extravasation |  | 30 days | 
| Hematuria |  | 30 days | 
| Catheter obstruction |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suprapubic Catheterization, Transurethral Catheterization, Rectal Cancer, Laparoscopic Surgery