Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02479685 |
| Other study ID # |
SORD-BILL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 5, 2015 |
| Last updated |
June 19, 2015 |
| Start date |
June 2014 |
| Est. completion date |
June 2015 |
Study information
| Verified date |
June 2015 |
| Source |
Catholic University of the Sacred Heart |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Italy: National Institute of Health |
| Study type |
Interventional
|
Clinical Trial 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.
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
- 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.
