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OpenTrials
Completed

NCT Number: NCT02166749

Clinical Follow up After Subtotal and Total 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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Turku University Hospital

Turku, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • benign indication for hysterectomy

Exclusion criteria

  • abnormal Pap smear

Treatment and study plan

Subtotal abdominal hysterectomy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2011
Study completion
2011
First posted
Jun 18, 2014
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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