SORD-BILL Vs Conventional Options During Sacral Colpopexy for POP
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 <III for posterior
           compartment.

        -  No uterine cervix dysplasia or endometrial disorders.

        -  No uterine size larger than conform 10 weeks gestation

      Study procedures Standard sacral colpopexy with subtotal hysterectomy With the patient in the
      Trendelenburg position (≥30°), after insertion of a 16F Foley urethral catheter, adequate
      pneumoperitoneum was induced. Uterine manipulator is used to move the uterus.A 10-mm
      laparoscope was introduced through the umbilicus and two 5-mm trocars were placed 2 cm
      medially and superiorly to the anterosuperior iliac spines. After thorough evaluation of the
      peritoneal cavity and, if necessary, completion of adhesiolysis, an additional 5- to 12-mm
      trocar was placed under visual control in the midline half way between the pubic symphysis
      and umbilicus. In the case of obesity or short umbilicopubic length, the 5-to 12-mm trocar
      was placed at the umbilicus and the 10-mm optical trocar was inserted in midline half way
      between the xiphoid process and umbilicus. The first step of LSC consisted of locating useful
      anatomic landmarks (outline of the promontory, iliac bifurcation, left common iliac vein,
      right ureter) and exposing the longitudinal vertebral ligament covering the sacral
      promontory. This was accomplished by opening the parietal peritoneum and gentle sharp and
      blunt dissection of retroperitonal tissue. Median sacral vessels were pushed back inward
      during dissection or coagulated if necessary. Then the peritoneal incision was prolonged
      along the right pelvic wall up to the uterine isthmus, paying careful attention to the ureter
      when mesh subperitonealization was scheduled.

      The subtotal hysterectomy started now. The round ligaments are coagulated and cut to enter
      the retroperitoneum. The broad ligaments/ovarian pedicles are sealed with bipolar diathermy
      and divided with monopolar scissors. Anterior and posteriors leaves of the broad ligaments
      peritoneum are divided with monopolar scissors. The incision is carried anteriorly. The
      bladder peritoneum is incised distal to the cervicouterine junction. Paravescical and
      pararectal spaces are developed. After both uterine arteries were coagulated using bipolar
      diathermy and monopolar forceps and the bladder dissection was completed, supracervical
      separation of the uterus wasperformed using a monopolar hook after removal of the uterine
      manipulator. The uterus was then morcellated by drawing the specimen into the morcellator
      (ROTOCUT G1 Morcellator, KARL STORZ GmbH & Co. KG, Tuttlingen, Germany).

      The pouch of Douglas was incised between the left and right uterosacral ligaments and the
      rectovaginal space was dissected along the posterior vaginal wall. Margins of dissection were
      the perineal body inferiorly and rectovaginal ligament laterally. To cover all the dissection
      space without tension, an adequately shaped Prolene mesh (Ethicon, Inc) was placed and fixed
      to the vaginal wall by five 3-0 nonabsorbable sutures. The first suture was applied in
      midline at the perineal apex of the mesh. Two sutures for each side were applied on the
      middle and upper portions of the posterolateral vaginal walls. The vesicouterine peritoneum
      was opened and vesicouterine and vesicovaginal spaces were dissected along the uterine and
      vaginal walls. Dissection limits were the trigonal region (emphasized by the Foley catheter)
      inferiorly and bladder pillars laterally. Also in this case an adequately shaped Prolene mesh
      covering all the dissection space without tension was inserted and fixed to the vaginal wall
      with five 3-0 nonabsorbable sutures. The first suture was applied at midline at the vesical
      apex of the mesh. Two sutures for each side were located on the middle and upper portions of
      anterolateral vaginal walls. The peritoneum of the right broad ligament between the round
      ligament-ovarian ligament superiorly and parametrial portion of uterine vessels inferiorly
      was incised so as to rejoin the previous right peritoneal incision, and the anterior mesh was
      passed through the incision. The two meshes were threaded up toward the promontory under
      visual control from the vagina so as to lift the prolapse vaginal walls without excessive
      tension. Meshes were fixed to the longitudinal vertebral ligament with one 0 non-absorbable
      suture on a noncutting needle . The operation was completed by re-peritonealization.

      PKS BiLL technology Using PKS bipolar laparoscopic loop can simplify cervical amputation and
      decreased the time required for the detachment of the uterine corpus, which many consider the
      more difficult part of laparoscopic subtotal hysterectomy. In addition, the loop system
      allows the supracervical separation of the uterus at or above the level of the coagulated
      uterine vessels, therefore minimising the risk of slippage or retraction of the vessels. The
      bipolar technology could add an ulterior advantage in terms of safety and operating procedure
      time reduction.

      In the same way the use of PKS plasmasord bipolar morcellator could reduce the risk of
      injuries. The lightness of this instrument could increase the procedure feasibility.
    

Intervention name(s): PKS BILL-PKS PlasmaSORD Versus Conventional surgical techniques
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment