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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03065855
Enrollment
220
Registered
2017-02-28
Start date
2017-02-28
Completion date
2017-08-31
Last updated
2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectum Cancer

Keywords

laparoscopic mesorectal excision, rectal cancer, urinary distention

Brief 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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief,but there is no clear data on the incidence of urine retention.Longer retaining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

Detailed 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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.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 .

Interventions

PROCEDUREEarly 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.

PROCEDURENormal 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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Post-operative urinary retention requiring re-catheterisation1 day following urethral catheter removalDevelopment 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

Secondary

MeasureTime frameDescription
UrethrorrhagiaWithin 7 days of urethral catheter removaltake a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia.
Urinary tract infectionWithin 7 days of urethral catheter removalBefore 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.

Countries

China

Contacts

Primary ContactXU Lai
drxulai@pumch.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026