Comparison of PHVP of Different VTH Methods

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

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

Study Overview

• Status: Completed
• Conditions: Vault Prolapse, Vaginal
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 213

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1986
• Primary Completion (Actual): December 31, 2001
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Vault prolapse; Vaginal total hysterectomy
• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Uterine Prolapse
• Other Study ID Numbers: 201601062RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No