This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.

Introduction Pelvic-organ prolapse, in which the pelvic organs (uterus, bladder, and bowel) protrude into or past the vaginal introitus, is a condition often treated with surgery1,2. Women have an 11 percent risk of surgery for prolapse or urinary incontinence by 80 years of age, and of this 11 percent, almost one third of the women have a second surgery3. This fact points to the need for improved treatment of pelvic-floor disorders. Numerous surgical procedures have been described for the management of POP. Vaginal surgery may be associated with less postoperative pain and a more rapid return to daily living than abdominal repair4,5. However, in a randomised study, sacrocolpopexy was twice as likely to result in optimal anatomical outcome as vaginal surgery6. Laparoscopic sacrocolpopexy provides the potential to combine the success rates of an abdominal approach with the faster recovery associated with a minimally invasive technique. Tissue dissection and mesh placement may also be facilitated by the magnification and field of view permitted by the laparoscopic approach7-10. These benefits must be balanced against a longer operating time from 150 to 250 minutes according to surgeons' experience. In addition, this procedure is often associated to subtotal hysterectomy (LSH) for the reasons of prevention (post-menopause age) or uterine diseases, which improve still more the operating time. Literature studies reports that the use of electrosurgical loop decreased the time required for resection of the uterine cervix during LSH for benign uterine conditions. Moreover LSH can be performed more easily with a powered morcellator for removal of the uterus. These devices facilitate and increase the safety of this procedure11,12.

However, the available laparoscopic morcellators may be difficult to use (weight, ergonomics, etc.) and there are potentially serious complications unreported in the medical literature13.

This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.

Secondary endopoints of this comparison are incidence of intra- or postoperative complications estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.

Statistical Analysis and Study Design This is a single Institution prospective randomized clinical trial conducted at the Catholic University of the Sacred Heart, Rome.

To have an imbalanced results and to reduce any bias, a randomization list has been checked.

Probability (p) values will be considered to be statistically significant at the <0.05 level.

There will be recruited 50 patients to treat using PK BiLL/PKS plasmasord and 50 patients to treat with standard monopolar hook/standard morcellator comparing these two techniques in terms of operative time, estimated blood loss and other intra- or post operative complications, postoperative pain, days of hospitalization, costs. All patients will be adequately informed and inserted in the study only after having read and signed an informed consent. Diagnostic, clinical and surgical data of each patient will be prospectively recorded. At the end of the procedure, a schedule will be compiled with intraoperative data. All clinical and histologic data will be recorded prospectively using a database. Pain associated with the procedure will be evaluated by a subjective assessment (analysis of VAS scale values reported by patients at 8 and 24 hours after surgery). Post-operative complications will be evaluated during the first 30 days after surgery according to Dindo's classification14.

Consort diagram of the study

Study Objectives

Primary endpoint To compare operative time for laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP using PKS BILL and PKS plasmasord technology (bipolar laparoscopic loop and bipolar morcellator) vs. conventional monopolar hook and conventional mechanic morcellator in order to reduce this operative time.

Secondary endpoints To compare

• Intra- or post operative complications (Urinary, Intestinal, Nervous)
• Estimated blood loss
• Postoperative pain
• Days of hospitalization
• Costs for the health care system.

Inclusion/exclusion criteria

For patients

• Age ≤ 80 years
• Patient's informed consent
• American Society of Anesthesiologists: < class III or IV
• Physiologic, surgical or iatrogenic menopause.
• No previous major abdominal surgical procedures

For diseases

• POP-Q stage III/IV for anterior and/or apical compartment; stage \

Inclusion Criteria:

For patients

• Age ≤ 80 years
• Patient's informed consent
• American Society of Anesthesiologists: < class III or IV
• Physiologic, surgical or iatrogenic menopause.
• No previous major abdominal surgical procedures

For diseases

• POP-Q stage III/IV for anterior and/or apical compartment; stage \