None listed
Conditions
Brief summary
This project aims to determine the best surgical method of suspending the vagina after hysterectomy for pelvic organ prolapse. This will be measured by checking for symptomatic and objective recurrence of prolapse at multiple time points after the surgery. Participants will include all those with symptomatic POP requesting hysterectomy as part of the surgical management for their symptoms. Patients will be recruited from public and private clinics and surgeries will be performed by gynaecologists or accredited trainees. Participants will be randomised in equal probablity to a vaginal or laparoscopic approach for hysterectomy and the subsequent suspension of the vaginal vault (apex). There is a strict surgical protocol for surgeons to adhere to and patient will undergo subjective and objective assessment prior to surgery and then at several timepoints post surgery. We expect to identify that both methods of vaginal suspension are equivalent based on the primary outcome
Interventions
Laparoscopic uterosacral ligament suspension (L-USLS). This is an operation already performed by the unit but we are comparing it to another routine suspension of the uterosacral ligament but perfromed vaginally (V-USLS)
Surgical approach in the laparoscopic group will conform to the following approach:
• Abdominal entry as per surgeon preference
• Laparoscopic hysterectomy with use of bipolar and monopolar instruments or vessel sealant device (eg. Ligasure, Harmonic etc)
• Use of McCartney tub
Laparoscopic uterosacral ligament suspension (L-USLS). This is an operation already performed by the unit but we are comparing it to another routine suspension of the uterosacral ligament but perfromed vaginally (V-USLS) Surgical approach in the laparoscopic group will conform to the following approach: • Abdominal entry as per surgeon preference • Laparoscopic hysterectomy with use of bipolar and monopolar instruments or vessel sealant device (eg. Ligasure, Harmonic etc) • Use of McCartney tube or other device for colpotomy • Vault suspension using 0 PDS or V-loc bilaterally with at least two bites of uterosacral ligament with attachment to vaginal vault • Closure of vault • Anterior vaginal repair with 2/0 PDS and 2/0 vicryl if residual defect after suspension • Posterior repair if required with 2/0 PDS, 1 vicryl and 2/0 vicryl using site specific repair or midline plication • Cystoscopy Approximate duration 2.5 hours. Will be performed by gynaecologist or urogynaecologist. Practitioners performing this operation have agreed to perform operation in this manner and feedback from the group has been sought to determine the most appropriate techniques.
Sponsors
Anna Rosamilia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All participants between the ages of 18-80 with symptomatic stage II-III POP requesting surgery including hysterectomy Capable of providing informed consent and able to return for follow up.
Exclusion criteria
Any previous prolapse surgery Previous surgery in the treatment area in the last year. Systemic steroids use within the last 3 months Pelvic organ prolapse (POP) > stage 3 according to pelvic organ prolapse quantification system Transvaginal mesh Serious systemic disease or any chronic condition that could interfere with study compliance Co-morbidities that would make a laparoscopic approach inappropriate A surgical history that would make a vaginal or laparoscopic approach innapropriate Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
Outcome results
None listed