None listed
Conditions
Brief summary
It is a standard part of performing keyhole surgery (laparoscopy) in gynaecology to insert a urinary catheter at the time of surgery. The optimal time to remove this urinary catheter is unknown. Some surgeons remove it immediately, whilst others keep the urinary catheter for some time (usually until the next day). The duration for which the urinary catheter is left in may have an effect on post-operative lower urinary tract symptoms and complications, such urinary tract infections and difficulty emptying the bladder. Up to 2 in 10 women may have difficulty passing urine or emptying the bladder properly after surgery. It is hypothesised that earlier removal of the urinary catheter after surgery may potentially increase the risk of this happening. Around 1 in 10 women may get a urinary tract infection after surgery. It is hypothesised that the risk of this occurring may be increased if the urinary catheter is left in for longer durations, or if a woman has difficulty emptying her bladder properly after surgery. Moreover, it is unknown as to what is the best means to assess whether a woman is emptying her bladder properly before being discharged from hospital after keyhole surgery. In the Department of Endo-Gynaecology at the Royal Hospital for Women and for patients of Dr Stephen Lyons at the Mater Hospital, there is a standard protocol where, after removal of the urinary catheter, women undergo serial bladder scans to measure the volume of urine left inside the bladder after voiding (post void residual urine volume, PVR). Women are not discharged from hospital until they are able to void at least 150 ml of urine on 2 consecutive occasions, and have a PVR of <100 ml after each of these voids. In contrast at many other institutions, no such protocol exists, and women are eligible for discharge from hospital without undergoing any bladder scans. It is hypothesised that women who are discharged from hospital with undiagnosed difficulty in emptying their bladder properly after their keyhole surgery may potentially have a higher risk of developing urinary tract infection and lower urinary tract symptoms. The objective of the study is to test these hypotheses, and thus allow more evidence-based practice in bladder care after gynaecological laparoscopy. This study is a prospective, randomised, multi-centre, clinical study, enrolling 690 women undergoing gynaecological laparoscopic surgery for benign indications, who would usually be expected to stay overnight due to their surgery. Women randomised to the study will have their scheduled surgery according to their treating team’s recommendations. Before surgery, subjects will complete a validated questionnaire regarding urinary symptoms and have a urine test to look for urinary tract infection. They will also be asked to void into a special device which will measure the rate and volume of urine flow (uroflowmetry), and a PVR will be measured. At the time of surgery, women will be randomised to one of two equally sized groups. One group of women will have the urinary catheter removed at 0600 hours on the morning after their surgery. This group of women will be managed according to the current standard protocol of the Department of Endo-Gynaecology at the Royal Hospital for Women. The other group of women will have the urinary catheter removed immediately at the end of surgery. This group of women will be eligible for discharge from hospital when they are able to void at least 150 ml on 2 consecutive occasions. These women will also undergo bladder scans after voiding, but the results of the bladder scan will be blinded from the staff and patient, and will not influence the decision for hospital discharge. After surgery, all women will be followed for 6 weeks post-operatively with health care visits and have their urinary function monitored. Permission will be sought from subjects for follow-up at 1 year after surgery.
Interventions
It is standard surgical practice to place an indwelling catheter during laparoscopy for gynaecological surgery to increase visualisation of the pelvic organs and to minimise the risk of intraoperative bladder injuries, in particular at the placement of the suprapubic laparoscopic port. It is the practice of some surgeons to leave the urinary catheter in situ post-operatively, whilst others remove the catheter immediately post-operatively.
The primary objective of this clinical investigation i
It is standard surgical practice to place an indwelling catheter during laparoscopy for gynaecological surgery to increase visualisation of the pelvic organs and to minimise the risk of intraoperative bladder injuries, in particular at the placement of the suprapubic laparoscopic port. It is the practice of some surgeons to leave the urinary catheter in situ post-operatively, whilst others remove the catheter immediately post-operatively. The primary objective of this clinical investigation is to determine whether immediate removal of the urinary catheter after laparoscopic surgery for benign non-hysterectomy gynaecological conditions (excluding surgery for prolapse and urinary incontinence) will affect the rate of post-operative complications involving the urinary tract. Patients in the immediate catheter removal group will have the urinary catheter removed in the operating theatre at the completion of surgery. With regards to bladder function, the patient is considered fit for discharge when she is able to void >=150 ml on two successive occasions. Other factors may prevent discharge and these will be documented. This reflects the current standard practice at many institutions after laparoscopy for benign gynaecological conditions (except prolapse and incontinence). In addition to the above standard practice, study subjects allocated to this group will also have their PVR measured by bladder scan (in accordance to the parameters outlined above). Medical staff and the study subjects will be blinded from the results of the bladder scan. Accordingly, the decision for timing of hospital discharge is not influenced by the results of the bladder scan. This reflects the current standard practice at many institutions where bladder scans are not routinely performed after laparoscopy for benign gynaecological conditions. Bladder scans may be performed when there is a clinical indication to measure the PVR (for example, when the subject is unable to void >=150 ml on two successive occasions). The results of these bladder scans, and how they influence the management and timing of hospital discharge, will be documented.
Sponsors
Associate Professor Jason Abbott
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Elective laparoscopy for a benign gynaecological condition - Patients to be aged >=18 years at time of surgery - Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up - Patients who are capable of, and have given written informed consent to their participation in the study. - Patients presenting with benign gynaecological conditions that require surgical intervention as agreed to by the patient and her attending medical team.
Exclusion criteria
- Concurrent involvement in other research studies - Past history of incontinence surgery - Surgery for urinary incontinence or prolapse - Suspected or confirmed gynaecological malignancy - Patients scheduled for hysterectomy as part of their surgical procedure - Patients with long-term bladder catheterisation (intermittent or permanent) - Suspected or confirmed pregnancy at the time of surgery - Intermittent flow pattern on uroflowmetry (indicative of pre-existing voiding dysfunction) - Preoperative PVR >=150 ml
Outcome results
None listed