Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum

Rectum Cancer Clinical Trial

Official title:

Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03065855
• Other study ID #: ARCTIC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: February 23, 2017
• Start date: February 2017
• Est. completion date: August 2017

Study information

• Verified date: January 2017
• Source: Peking Union Medical College Hospital
• Contact: XU Lai
• Email: drxulai[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum

Description:

For a better view to avoid accidental trauma and monitoring kidney function during surgery and in the post-surgery period, patients undergoing abdominal operations will usually have a urinary catheter placed in the bladder before the surgery. Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.

Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Competent to consent to participate in trial

2. Patients with rectal cancer who underwent total or tumor-specific-mesorectal excision with colorectal or colonanal anastomosis

3. Elective surgery

4. ASA classification of 1~3

5. If male, international prostate symptom score <20.

Exclusion Criteria:

1. Combined pelvic surgery(pelvic lymph node dissection, hysterectomy, salpingo-oophorectomy, posterior vaginectomy, cystectomy, ureteral double-J stenting, ureterectomy, ureteroureterostomy, prostatectomy)

2. Postoperative complications with a Dindo grade III or more

3. Known urinary disease(end-stage renal disease, benign prostatic hyperplasia, neurogenic bladder, malignancy)

Related Conditions & MeSH terms

• Rectal Neoplasms
• Rectum Cancer

Intervention

Procedure:
• Early removal group
Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.
• Normal removal group
Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative urinary retention requiring re-catheterisation	Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period	1 day following urethral catheter removal
Secondary	Urinary tract infection	Before catheter removal, take a mid-stream urine sample for microscopy and culture. Leucocyte in urine =5/HP for man and =10/HP for woman is defined as bacteruria with urinary irritation or not.A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture.	Within 7 days of urethral catheter removal
Secondary	Urethrorrhagia	take a mid-stream urine sample for Clinical urine tests and RBC=3/HP is defined as urethrorrhagia.	Within 7 days of urethral catheter removal