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OpenTrials
Completed

NCT Number: NCT03858673

Comparison of PHVP of Different VTH Methods

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

Completed

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Key information

Conditions

Vault Prolapse, Vaginal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse

Age range

20 year–85 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Received VTH with or without other combined operations.

Exclusion criteria

  • Laparoscopic-assisted vaginal hysterectomy (LAVH)
  • Conversion to an abdominal approach
  • Unsatisfactory medical record

Treatment and study plan

VTH via the Tsuzi method with residual uterine ligament ligation

Procedure

VTH via the Tsuzi method with residual uterine ligament ligation

Primary outcomes

  1. Post-hysterectomy vault prolapse

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Comparison of the Vault Prolapse Rate After Vaginal Hysterectomy With or Without Residual Uterine Ligament Ligation

Important dates

Study start
1986
Primary completion
2001
Study completion
2017
First posted
Mar 1, 2019
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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