Clinical trial NCT05252637: Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse
Official title: Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Posterior Vaginal Wall Prolapse
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 64
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized Clinical Trial on Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement VS sacral colpopexy isolated for vaginal posterior prolapse

Detailed description: Laparoscopic sacral colpopexy is the gold standard procedure for pelvic organ prolapse. Anyway, vaginal fascial surgery is already considered the most appropriate for posterior vaginal prolapse. This prospective randomized pilot study is aimed to verify if the combination of laparoscopic duplication of vaginal fascia with absorbable sutures could increase benefits of sacral colpopexy on the posterior vagina in terms of prolapse (evaluating 1 year POP-Q).

Secondary endpoints 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 Pia Fondazione Panico of Tricase, Italy.

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 32 patients for Groups. Group 1: Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement Vs Group 2: Laparoscopic sacral colpopexy isolated for vaginal posterior prolapse.

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 classification.

Eligibility criteria: Age ≤ 80 years Patient's informed consent American Society of Anesthesiologists: \< class III or IV

No previous major abdominal surgical procedures POP-Q stage \> or =III for posterior compartment. No uterine cervix dysplasia or endometrial disorders. No uterine size larger than conform 10 weeks gestation

Primary outcomes:
measure: POP-Q
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: Pia Fondazione Panico
state: Lecce
Study officials:
affiliation: Pia Fondazione Panico
name: Andrea Morciano
role: PRINCIPAL_INVESTIGATOR
References: