Comparison of PHVP of Different VTH Methods

Vault Prolapse, Vaginal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858673
• Other study ID #: 201601062RINA
• Status: Completed
• Start date: January 1, 1986
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse
• Vault Prolapse, Vaginal

Intervention

Procedure:
• VTH via the Tsuzi method with residual uterine ligament ligation
VTH via the Tsuzi method with residual uterine ligament ligation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

References & Publications (5)

Buca DIP, Liberati M, Falò 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. — View Citation

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. — View Citation

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. — View Citation

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)/Internation — View Citation

Ker CR, Lin KL, Loo ZX, Juan YS, Long CY. Comparison of Uphold(TM) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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