Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05252637
Study type	Interventional
Source	Azienda Ospedaliera Cardinale G. Panico
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2019
Completion date	January 20, 2022

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms