Clinical trial NCT03553511: Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse.
Official title: Short and Long-term Outcomes After Total Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments Versus Vaginal Hysterectomy With McCall Culdoplasty for the Treatment of Stage II-III Pelvic Organ Prolapse.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Laparoscopy
Hysterectomy
Uterosacral ligaments suspension
McCall culdoplasty
Post-hysterectomy vault prolapse
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Clinical trial
Primary purpose: PREVENTION

Brief summary: The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons.

Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication.

Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.


Eligibility criteria: Inclusion Criteria:

* Stage II-III pelvic organ prolapse
* Bilateral preservation of the ovaries
* Sexually active women

Exclusion Criteria:

* Smoking
* Body Mass Index \> 30
* Strenuous activity (frequent heavy lifting)
* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities
* Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period

Primary outcomes:
measure: Recurrence
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Urinary impact questionnaire score (total score minimum: 0, maximum: 100)
timeFrame: 12 months after surgery
measure: Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100)
timeFrame: 12 months after surgery
measure: Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100)
timeFrame: 12 months after surgery
measure: Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48)
timeFrame: 12 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Jvan Casarin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Antonella Cromi, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Università degli Studi dell'Insubria
name: Fabio Ghezzi, M.D.
role: STUDY_DIRECTOR
References: