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Lateral Vaginal Wall Site-specific Defect Reconstructions

NCT04635514 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2020-11-19

No results posted yet for this study

Summary

LATERAL COLPORRHAPHY: A NEW SURGICAL INTERVENTION:

CASE SERIES STUDY

Background The surgical anatomy of site-specific defects of lateral vaginal wall (LVW) prolapse into the canal and its treatment are described for the first time.

Materials and Methods Thirty-two women who presented with symptomatic LVW prolapse (deep dyspareunia, sensation of vaginal fulness, and heaviness) were study. Before surgery, gross anatomy and the lateral colporrhaphy rehearsals had been performed on ten-human fresh female cadavers. A case series study was designed and conducted. Objectives were to ascertain the surgical anatomy within lateral vaginal wall site-specific defects; to evaluate whether lateral colporrhaphy can cure or improve symptoms; to describe a new lateral colporrhaphy. The primary outcome measured occurrences of site-specific defects within the lateral vaginal wall. The secondary outcome measured objective and subjective cure rates of lateral colporrhaphy.

Results Twenty-eight women (87.5%) concluded the study. The mean age of women was 46 ± 12 years, BMI 26.7 ± 2 kg/m2, and vaginal parity 2 ± 1. In all subjects, LVW defects had bulged into the vaginal canal. Lateral colporrhaphy yielded objective and subjective cure rates of 93% and 97%, respectively. Symptomatic improvements were recorded in 7%. The LVW surgical anatomy consisted of the full thickness of the vaginal wall, pubovaginalis muscle with fascia, and the perineal membrane.

Conclusions Symptomatic site-specific defects occur within the lateral vaginal wall. Lateral colporrhaphy cures or improves symptoms in this study group. The new lateral colporrhaphy procedure is a simple surgical intervention and is easy to perform.

Conditions

  • Gynecological Disorder

Interventions

PROCEDURE

Lateral colporrhaphy

Sponsors & Collaborators

  • Institute of Gynecology, Inc.

    lead OTHER

Principal Investigators

  • Maria Ostrzenska · Institute of Gynecology, Inc.

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-15
Primary Completion
2019-05-14
Completion
2019-11-07

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635514 on ClinicalTrials.gov