NCT03858673

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1986

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1986

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2001

Completed
16 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
Last Updated

March 6, 2019

Status Verified

February 1, 2016

Enrollment Period

16 years

First QC Date

February 26, 2019

Last Update Submit

March 4, 2019

Conditions

Vault Prolapse, Vaginal

Keywords

Vault prolapseVaginal total hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Post-hysterectomy vault prolapse

    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.

    Between January 1986 and December 2001

Study Arms (2)

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

Without ligations group

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

Interventions

VTH via the Tsuzi method with residual uterine ligament ligationPROCEDURE

VTH via the Tsuzi method with residual uterine ligament ligation

Ligations group

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

    PMID: 19941278RESULT

  • Buca DIP, Liberati M, Falo E, Leombroni M, Di Giminiani M, Di Nicola M, Santarelli A, Frondaroli F, Fanfani F. Long-term outcome after surgical repair of pelvic organ prolapse with Elevate Prolapse Repair System. J Obstet Gynaecol. 2018 Aug;38(6):854-859. doi: 10.1080/01443615.2017.1419462. Epub 2018 Mar 14.

    PMID: 29537324RESULT

  • Ker CR, Lin KL, Loo ZX, Juan YS, Long CY. Comparison of UpholdTM Vaginal Mesh Procedure with Hysterectomy or Uterine Preservation for the Treatment of Pelvic Organ Prolapse. Sci Rep. 2018 Jun 21;8(1):9438. doi: 10.1038/s41598-018-27765-8.

    PMID: 29930249RESULT

  • Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.

    PMID: 26634203RESULT

  • Chen CH, Hsiao SM, Chang TC, Wu WY, Lin HH. Transvaginal cystocele repair using pursestring technique reinforced with custom-tailored two-armed mesh. Urology. 2011 Dec;78(6):1275-80. doi: 10.1016/j.urology.2011.07.1380. Epub 2011 Sep 9.

    PMID: 21908027RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ho-Hsiung Lin, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 1, 2019

Study Start

January 1, 1986

Primary Completion

December 31, 2001

Study Completion

December 31, 2017

Last Updated

March 6, 2019

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share