An interventional study of Early removal group and Normal removal group in Rectum Cancer, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining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
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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.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
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1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 220 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
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Exclusion Criteria:
All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 2 days following surgery.
Procedure: Early removal group
All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.
Procedure: Normal 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.
Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.
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
Time frame: 1 day following urethral catheter removal
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.
Time frame: Within 7 days of urethral catheter removal
Urethrorrhagia
take a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia.
Time frame: Within 7 days of urethral catheter removal
Plan to share: Yes — Other researchers have access to data in the form of published papers
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital