None listed
Conditions
Brief summary
The colpotomiser is a key instrument utilised at laparoscopic hysterectomy. In the Western Sydney Local Health District (WSLHD), the Rumi II® [Cooper Surgical] and the Biswas [Storz] are two commonly used uterine manipulators during laparoscopic hysterectomy. Both of these devices are FDA approved and already in general use. Currently, there are multiple published articles evaluating the effectiveness of individual colpotomisers at hysterectomy, however there are few randomised controlled trials comparing devices, and none comparing Rumi II and Biswas. The study aims to recruit 96 patients over a 12 month period. The primary outcome is operative time. Secondary outcomes include standard peri-operative measures including blood loss, blood transfusion, complications, readmission, return to theatre, and conversion to an alternative colpotomiser device. A subjective surgeon assessment using a Likert scale will assess the ease of insertion, manipulation, surgical access and maintenance of pneumoperitoneum.
Interventions
Laparoscopic hysterectomy requires the use of a colpotomiser device. This allows the uterus to be manipulated to provide adequate surgical access, gaining separation from adjacent structures (such as the bladder and ureters) which are to be protected and conserved. There are many different types of colpotomiser device. One such device is the Biswas uterovaginal elevator (Karl Storz, Germany)- reusable rigid rod which screws into the uterocervical canal and over which a silicone cone delineates t
Laparoscopic hysterectomy requires the use of a colpotomiser device. This allows the uterus to be manipulated to provide adequate surgical access, gaining separation from adjacent structures (such as the bladder and ureters) which are to be protected and conserved. There are many different types of colpotomiser device. One such device is the Biswas uterovaginal elevator (Karl Storz, Germany)- reusable rigid rod which screws into the uterocervical canal and over which a silicone cone delineates the vaginal fornices. Another commonly used device is the Rumi II (Cooper Surgical, USA). The reusable handle is combined with disposable elements of varying size, including the articulating tips and the Koh-Efficient colpotomy cup with pneumo-occlusion balloon. There is minimal evidence to guide surgeons as to whether any particular colpotomiser performs better than another. The intervention in this trial does not change usual surgical care including insertion of one of these devices by the surgeon at the beginning of the procedure. The device is removed from the patient upon complete surgical separation of the uterus.
Sponsors
Australasian Gynaecological Endoscopy & Surgery Society (AGES)
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 No maximum
Healthy volunteers
No
Inclusion criteria
Women over the age of 18 years who are undergoing laparoscopic hysterectomy for any benign gynaecological indication
Exclusion criteria
Pregnancy. Known or suspected malignancy. Uterine size exceeding equivalence of 14 weeks gestation.
Outcome results
None listed