None listed
Conditions
Brief summary
Pelvic organ prolapse (POP) is a common condition affecting women, with vaginal childbirth. Sacral colpopexy is considered the gold standard operation for prolapse of the vaginal apex and can be performed via open, laparoscopic, or robot-assisted approaches, with comparable efficacy across access methods. A graft is used to suspend the vaginal apex from the sacral promontory. Graft options for the treatment of Pelvic Organ Prolapse have been Synthetic mesh - no longer approved for use by the TGA and Autologous fascia lata. Autologous Fascia Lata harvest requires an additional operative site, which may be associated with donor site morbidity such as pain, scarring, and delayed wound healing. Posterior rectus sheath (PRS) represents a novel alternative autologous graft that may mitigate these limitations. As a local abdominal fascial tissue, PRS can be harvested from the same operative field used for sacrocolpopexy, This study will describe the surgical techniques of robotic autologous posterior rectus sheath sacral colpopexy (PRS-AC) for bothersome apical prolapse and report 1-year anatomic and functional outcome
Interventions
Robot-assisted sacrocolpopexy using posterior rectus sheath (PRS) a novel alternative autologous graft for the treatment of pelvic organ prolapse. Harvested from local abdominal fascial tissue, PRS can be harvested from the same operative field used for sacrocolpopexy, eliminating the need for a separate thigh incision. The procedure will be completed in a single surgical session lasting approximately 90 minutes. All participating surgeons are suitably trained and proficient in performing POP-Q
Robot-assisted sacrocolpopexy using posterior rectus sheath (PRS) a novel alternative autologous graft for the treatment of pelvic organ prolapse. Harvested from local abdominal fascial tissue, PRS can be harvested from the same operative field used for sacrocolpopexy, eliminating the need for a separate thigh incision. The procedure will be completed in a single surgical session lasting approximately 90 minutes. All participating surgeons are suitably trained and proficient in performing POP-Q examination, robotic sacral colpopexy and posterior rectus sheath harvesting. The participating surgeons will receive standardised training in harvesting and PRS and placement of the graft onto the vagina. This training will involve direct observation of one case performed by the principal investigator. Following the observed case, the participating surgeon will perform three cases under the direct supervision of the principal investigator.
Sponsors
Epworth HealthCare
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Women 18 years old or older. • Consecutive women with greater than or stage 2 vaginal vault or uterine prolapse • Women that are able to comprehend and complete the study material
Exclusion criteria
• Women undergoing prolapse surgery who are unwilling or unable to participate in the study • Women who are unwilling or unable to give competent informed consent or unable to complete study questionnaires • Uterine abnormalities that exclude participation for subjects undergoing a sub-total hysterectomy are: o Abnormal endometrial thickness or sampling o Current or recent cervical dysplasia o Abnormal menstrual bleeding o Post-menopausal bleeding • High risk for endometrial cancer o Hereditary Non-Polyposis Colorectal Cancer (Lynch Syndrome), BRCA 1&2 o Tamoxifen therapy • High risk for general anaesthesia and/or laparoscopic surgery
Outcome results
None listed