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Comparison of PHVP of Different VTH Methods

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ClinicalTrials.gov Identifier: NCT03858673
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease Intervention/treatment
Vault Prolapse, Vaginal Procedure: VTH via the Tsuzi method with residual uterine ligament ligation

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.

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Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of the Vault Prolapse Rate After Vaginal Hysterectomy With or Without Residual Uterine Ligament Ligation
Actual Study Start Date : January 1, 1986
Actual Primary Completion Date : December 31, 2001
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Group/Cohort Intervention/treatment
Ligations group
VTH via the Tsuzi method with residual uterine ligament ligation (ligations group)
Procedure: VTH via the Tsuzi method with residual uterine ligament ligation
VTH via the Tsuzi method with residual uterine ligament ligation

Without ligations group
Traditional VTH without residual uterine ligament ligation (without ligations group)



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Between January 1986 and December 2001, all women who received VTH with or without other combined operations at National Taiwan University Hospital were recruited. In September 2016, a retrospective chart review was performed.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858673


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ho-Hsiung Lin, PhD National Taiwan University Hospital
Publications of Results:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03858673    
Other Study ID Numbers: 201601062RINA
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Vault prolapse
Vaginal total hysterectomy
Additional relevant MeSH terms:
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Uterine Prolapse
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases