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. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

ACTRN12611000414910.

Study name Bladder care following laparoscopy for benign non‐hysterectomy gynaecological conditions – a randomised controlled trial (ACTRN12611000414910)
Methods Study design: RCT
Participants Patients undergoing laparoscopic surgery for benign non‐hysterectomy gynaecological conditions
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); pre‐operative PVR ≥ 150 mL
Interventions Group A: immediate removal of the IUC post‐laparoscopic surgery for benign non‐hysterectomy gynaecological conditions
Group B: removal of the IUC at 6 am on the 1st post‐op day following laparoscopic surgery for benign non‐hysterectomy gynaecological conditions
Outcomes Incidence of post‐op UTI
Incidence and pattern of post‐op voiding dysfunction
PVR urine volume in patients before surgery
Duration of hospital stay
Re‐admission to hospital (incidence and indication)
Unscheduled presentation to general practitioner
Emergency department or outpatient service (clinic/rooms)
Economic analyses of the 2 modalities for care
Starting date 1 March 2012
Contact information Associate Professor Jason Abbott
Royal Hospital for Women
Barker Street
Randwick NSW 2031
Country: Australia
Phone: +61 2 93826111
Email: j.abbott@unsw.edu.au
Notes Recruitment status: not yet recruiting