Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05420831 |
Other study ID # |
Vaginal_or_laparoscopic |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 9, 2022 |
Est. completion date |
May 9, 2025 |
Study information
Verified date |
December 2023 |
Source |
Saint Petersburg State University, Russia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a prospective randomized controlled study, designed to compare efficacy and safety of
two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous
hysteropexy (SSHP) with synthetic mesh and laparoscopic sacrohysteropexy (LSHP), and the
impact of the surgery on quality of life.
Description:
BACKGROUND POP remains a widespread condition, that significantly affects patients' quality
of life. The estimated incidence of POP in women varies from 10% in young age to 40% after
menopause. Apical defect is the least frequent of all types of POP and occurs in 5-15% of
patients, however apical support is crucial to maintaining normal anatomy of the pelvic
floor.
Although the uterus itself is not the cause of POP, hysterectomy is the most common surgery
for POP. However there is a growing interest in uterine-sparing surgical techniques because a
lot of women express a desire to preserve uterus.
There are various techniques for uterine-sparing apical repair, including abdominal
(laparoscopic or robotic) and vaginal apical fixation. SSHP is the most studied method of
apical fixation and was originally performed with sutures. The use of transvaginal mesh for
SSHP is discussable in conjunction with numerous reports of complications and wariness
towards synthetic materials use. Some authors though reported of comparable effectiveness and
high safety of SSHP using mesh. Due to the lack of the reliable evidence, to date there are
no consensus about optimal method of hysteropexy, as LSHP is not without its drawbacks and
complications.
PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a
preoperative assessment: medical history, physical and vaginal examination, assessing pelvic
organ prolapse according to Pelvic Organ Prolapse Quantification System (POP-Q). All patients
will complete questionnaires validated in Russia: Pelvic Floor Disability Index (PFDI-20),
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, short form (PISQ-SF),
Patient Global Impression of Improvement (PGI-I).
MATERIALS AND METHODS The investigators hypothesis is that SSHP is non-inferior to LSHP in
terms of recurrence rate and complications. The sample size was calculated assuming an
objective cure rate of 92% as described in literature. With a power of 80%, a level of 0,05
and the non-inferiority margin at 15%, the sample size is 92 patients. The investigators
assume a drop-out rate of 10%, thus a total of 102 participants will be included in the
study.
All enrolled patients will be randomly assigned to SSHP or LSHP treatment groups in equal
ratio the day before the surgery, using computer randomization.
All data will be collected by medical staff not involved in treatment. Collected pre- and
postoperative data will be anonymized using unique codes, that patients will receive
immediately after randomization.
All surgical interventions will be performed by 3 qualified surgeons. Postoperative follow-up
will be performed 6, 12 and 24 months after surgery by 2 researchers, who will be blinded
about the type of intervention.