Clinical Follow up After Subtotal and Total Hysterectomy

NCT ID: NCT02166749

Last Updated: 2014-06-30

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

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominal Hysterectomy (& Wertheim)

Keywords

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Hysterectomy, long term follow up, subjective outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subtotal abdominal hysterectomy

107 women

Subtotal abdominal hysterectomy

Intervention Type PROCEDURE

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

Total abdominal hysterectomy

105 women

Subtotal abdominal hysterectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Total abdominal hysterectomy

Eligibility Criteria

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Inclusion Criteria

* benign indication for hysterectomy

Exclusion Criteria

* abnormal Pap smear
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Seija Ala-Nissilä

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juha Mäkinen, Professor

Role: STUDY_DIRECTOR

Turku University Hospital

Locations

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Department of Obstetrics and Gynecology, Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 27640066 (View on PubMed)

Other Identifiers

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ETMK:41/180/2010

Identifier Type: -

Identifier Source: org_study_id