Comparison of PHVP of Different VTH Methods

NCT ID: NCT03858673

Last Updated: 2019-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

1986-01-01

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vault Prolapse, Vaginal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ligations group

VTH via the Tsuzi method with residual uterine ligament ligation (ligations group)

VTH via the Tsuzi method with residual uterine ligament ligation

Intervention Type PROCEDURE

VTH via the Tsuzi method with residual uterine ligament ligation

Without ligations group

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

No interventions assigned to this group

Interventions

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VTH via the Tsuzi method with residual uterine ligament ligation

VTH via the Tsuzi method with residual uterine ligament ligation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Hsiung Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

References

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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.

Reference Type RESULT
PMID: 19941278 (View on PubMed)

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.

Reference Type RESULT
PMID: 29537324 (View on PubMed)

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.

Reference Type RESULT
PMID: 29930249 (View on PubMed)

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.

Reference Type RESULT
PMID: 26634203 (View on PubMed)

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.

Reference Type RESULT
PMID: 21908027 (View on PubMed)

Other Identifiers

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201601062RINA

Identifier Type: -

Identifier Source: org_study_id

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