NCT02166749

Brief Summary

The purpose of this study was to find out subjective and objective outcomes of patients undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years after the operation. The hypothesis is that there are similar outcomes after both types of operations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 1997

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

14.6 years

First QC Date

June 16, 2014

Last Update Submit

June 27, 2014

Conditions

Abdominal Hysterectomy (& Wertheim)

Keywords

Hysterectomy, long term follow up, subjective outcome

Outcome Measures

Primary Outcomes (1)

  • Number of participants having subjective symptoms after hysterectomy

    Urinary and bowel symptoms assessed with questionnaires and Visual Analog Scale. Sexual symptoms assessed with questionnaire.

    19 years and 33 years postoperatively

Secondary Outcomes (1)

  • Objective evaluation of pelvic organ prolapse after hysterectomy

    33 years postoperatively

Study Arms (2)

Subtotal abdominal hysterectomy

107 women

Procedure: Subtotal abdominal hysterectomy

Total abdominal hysterectomy

105 women

Procedure: Subtotal abdominal hysterectomy

Interventions

Subtotal abdominal hysterectomyPROCEDURE

Comparison of women undergoing subtotal abdominal hysterectomy (n=107) and women with total abdominal hysterectomy (n=105) a mean of 33 years ago.

Also known as: Total abdominal hysterectomy
Subtotal abdominal hysterectomyTotal abdominal hysterectomy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population included 212 patients operated on during February 1978 and May 1979 in Turku University Hospital. 107 women underwent subtotal and 105 women total abdominal hysterectomy.

You may qualify if:

  • benign indication for hysterectomy

You may not qualify if:

  • abnormal Pap smear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (1)

  • Ala-Nissila S, Haarala M, Jarvenpaa T, Makinen J. Long-term follow-up of the outcome of supracervical versus total abdominal hysterectomy. Int Urogynecol J. 2017 Feb;28(2):299-306. doi: 10.1007/s00192-016-3143-0. Epub 2016 Sep 17.

    PMID: 27640066DERIVED

Study Officials

  • Juha Mäkinen, Professor

    Turku University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

March 1, 1997

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

FI(1)