Comparison of PHVP of Different VTH Methods

Completed

• Conditions: Vault Prolapse, Vaginal
• Interventions: Procedure: VTH via the Tsuzi method with residual uterine ligament ligation

• Registration Number: NCT03858673
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To evaluate the post-hysterectomy vault prolapse (PHVP) rates performed using different methods of vaginal total hysterectomy (VTH).

Detailed Description

Objective: To evaluate the post-hysterectomy vault prolapse (PHVP) rates performed using different methods of vaginal total hysterectomy (VTH).

Methods: A computer search identified a total of 251 women who underwent VTH with/without concomitant surgeries between January 1986 and December 2001 in a single center. Thirty-eight women were excluded due to not only a vaginal approach. Of the remaining 213 women, 129 and 84 underwent VTH via the Tsuzi method with residual uterine ligament ligation (ligations group) and traditional VTH (without ligations group), respectively. The χ2 and Mann-Whitney U tests were applied to compare the data. The cumulative percentages of women without PHVP were calculated over time and compared using Kaplan-Meier curves and log-rank tests. A p value of less than 0.05 was considered statistically significant.

Study Timeline

• Study Start: 1986-01-01
• Primary Completion: 2001-12-31
• Status Verified: 2016-02
• Study Completion: 2017-12-31
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-03-01
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 213

Inclusion Criteria

1. Female
2. Received VTH with or without other combined operations.

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Exclusion Criteria

1. Laparoscopic-assisted vaginal hysterectomy (LAVH)
2. Conversion to an abdominal approach
3. Unsatisfactory medical record

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ligations group	VTH via the Tsuzi method with residual uterine ligament ligation	VTH via the Tsuzi method with residual uterine ligament ligation (ligations group)

Primary Outcome Measures

Name	Time	Method
Post-hysterectomy vault prolapse	Between January 1986 and December 2001	PHVP was defined as more than or equal to the second stage of descent of the vaginal vault was noted during the follow-up visits.