Rectal Cancer, Surgery
Conditions
Keywords
Suprapubic Catheterization, Transurethral Catheterization, Rectal Cancer, Laparoscopic Surgery
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.
Interventions
DEVICESuprapubic 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.
DEVICETransurethral 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.
Sponsors
Fujian Cancer Hospital
Fujian Provincial Hospital
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Catherization time | 6 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter-Associated Urinary Tract Infection | 30 days | — |
| Pain score | 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. |
| International Prostatic Symptom Score | 30 days | The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery. |
| Time to first ambulation | 7 days | — |
| Number of catheterization | 30 days | — |
| Urinary extravasation | 30 days | — |
| Hematuria | 30 days | — |
| Catheter obstruction | 30 days | — |
| Duration of hospital stay | 30 days | — |
Countries
China
Contacts
Primary ContactGuoxin Li, M.D., Ph.D.
Backup Contactjun Yan, M.D., Ph.D.
Outcome results
None listed