A Prospective Randomized Control Trial Comparing Immediate and 24-hours Delayed Catheter Removal Following Hysterectomy

NCT01182714 | Completed DMC

• 1 other identifier: Foley-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In Hong Kong, it was the most common gynaecological open procedure done and the number of hysterectomies performed increased by almost 50% in 2004 when compared to 1999. In-dwelling catheter use after uncomplicated abdominal hysterectomy has been the standard method for bladder treatment after the operation. It is traditionally advocated to assess urinary output and to prevent post-operative urinary retention as patients with abdominal wound are unable to increase the intra-abdominal pressure to aid voiding. However, in-dwelling catheters have been associated with increased white cell counts and higher rates of positive urine cultures, and subsequently urinary tract infection can lead to increased morbidity, duration of hospital stay, and overall healthcare cost. Duration of catheter use post-operatively is generally based on custom rather than evidence-based knowledge and therefore varies considerably. The current practice of the investigators hospital is to leave an in-dwelling catheter in-situ for 24 hours after an uncomplicated open gynaecological surgery. Schiotz et al showed that twenty-four-hour catheterization after common gynaecological procedures was associated with a low rate of voiding problems after catheter removal. Post-operative urinary retention leading to bladder atony may increase the long-term morbidity through increased risk of infection, detrusor instability and voiding difficulties. In-dwelling catheter in the immediate post-operative period will help to combat this problem. However, this has to be balanced against the potential risk of catheter-associated urinary tract infection which varies from 5% to 43% in the published trials. A prospective randomized study comparing immediate versus delayed catheter removal following hysterectomy showed that delayed removal after operation was not associated with an increased rate of febrile events or urinary tract infections, but a significantly higher subjective pain assessment. The size of the catheter used was 16F which was not the standard 12F that the investigators used in the investigators hospital setting. It is postulated that if a smaller caliber in-dwelling catheter is used, it will not result in an increased subjective pain assessment, and the catheter can be left in-situ for 24 hours without causing increased adverse outcomes but possibly reducing recatheterisation rate post-operatively.

Conditions

Hysterectomy

Keywords

Hysterectomy; Catheterisation

Outcome Measures

Primary Outcomes (1)

• the subjective pain assessment provided by the patient post-operatively

  pain assessment using visual analogue scale

  post operatively day 1

Secondary Outcomes (2)

• the rate of recatheterisation

  at 6 hours post-operatively

• incidence of symptomatic urinary tract infection

  up to 7 days after operation

Study Arms (1)

removal of catheter

OTHER

Procedure: immediate removal of in-dwelling catheter; Procedure: 24 hours delayed removal of catheter

Interventions

immediate removal of in-dwelling catheter PROCEDURE

removal of catheter

24 hours delayed removal of catheter PROCEDURE

removal of catheter

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All women required total abdominal hysterectomy +/- bilateral salpingo-oophorectomy for various benign gynaecological diseases in Queen Mary Hospital

You may not qualify if:

• a known history of neurological disorder
• a known history of urinary incontinence
• women who had recurrent urinary tract infections or positive urine culture (\>105 colony-forming units of an identified single uro-pathogen per milliliter of urine) pre-operatively
• women for whom a complicated procedure was encountered during the hysterectomy in which case in-dwelling catheter had to be kept post-operatively at the surgeon's decision
• women who had spinal anaesthesia as the choice of anaesthesia or received patient-controlled analgesia as post-operative pain relief.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

  PMID: 34184246 DERIVED

Study Officials

• Joyce Chai, MBChB

  Queen Mary Hospital, University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 17, 2010
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 20, 2010

Record last verified: 2010-08

Locations

HK (1)