Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse

Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse: a Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Posterior Vaginal Wall Prolapse
• Intervention / Treatment: Procedure: Laparoscopic Fascial Posterior Vagina Duplication

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lecce
    • Tricase, Lecce, Italy, 73039
      • Pia Fondazione Panico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duplication plus LSC; Laparoscopic duplication of posterior vagina plus mesh placement	Procedure: Laparoscopic Fascial Posterior Vagina Duplication; Laparoscopic Fascial Posterior Vagina Duplication with absorbable sutures for posterior prolapse (plus standard Sacral Colpopexy)
No Intervention: LSC; Laparoscopic Sacral Colpopexy with mesh placement on posterior vagina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POP-Q	POP-Q evaluation	1 year

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Cardinale G. Panico
• Investigators: Principal Investigator: Andrea Morciano, Pia Fondazione Panico

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 13, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Uterine Prolapse
• Other Study ID Numbers: 1202TricaseLSC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No