Clinical Follow up After Subtotal and Total Hysterectomy

June 27, 2014 updated by: Seija Ala-Nissilä, Turku University Hospital

Ultra Long-term Follow-up of the Outcome After Subtotal Versus Total Abdominal Hysterectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To evaluate ultra long-term follow-up after subtotal and total hysterectomy in patients operated on during 1978-1979 in Turku University Hospital, Finland.

Methods: From the original cohort of 212 patients 193 were sent a postal questionnaire in 1997 to find out possible symptoms related to hysterectomy. Again in 2011 a questionnaire based evaluation with a possibility of a clinical visit to study hospital was done for 153 patients. In the first evaluation a self-made questionnaire and in the second evaluation validated questionnaires were used. During a follow-up visit a clinical examination using also POP-Q-system was done. Additionally, hospital records of the patients were reviewed to find out subsequent operations after hysterectomy.

Study Type

Observational

Enrollment (Actual)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Department of Obstetrics and Gynecology, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • benign indication for hysterectomy

Exclusion Criteria:

  • abnormal Pap smear

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subtotal abdominal hysterectomy
107 women
Procedure: Subtotal abdominal hysterectomy
Comparison of women undergoing subtotal abdominal hysterectomy (n=107) and women with total abdominal hysterectomy (n=105) a mean of 33 years ago.
Other Names:
  • Total abdominal hysterectomy
Total abdominal hysterectomy
105 women
Procedure: Subtotal abdominal hysterectomy
Comparison of women undergoing subtotal abdominal hysterectomy (n=107) and women with total abdominal hysterectomy (n=105) a mean of 33 years ago.
Other Names:
  • Total abdominal hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants having subjective symptoms after hysterectomy
Time Frame: 19 years and 33 years postoperatively

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

Sexual symptoms assessed with questionnaire.
19 years and 33 years postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective evaluation of pelvic organ prolapse after hysterectomy
Time Frame: 33 years postoperatively
Gynecological examination and measurements using pelvic organ prolapse quantification system (POP-Q) to find out the number of participants having prolapse.
33 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Study Director: Juha Mäkinen, Professor, Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ETMK:41/180/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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