Clinical Follow up After Subtotal and Total Hysterectomy

Completed

• Conditions: Abdominal Hysterectomy (& Wertheim)
• Interventions: Procedure: Subtotal abdominal hysterectomy

• Registration Number: NCT02166749
• Lead Sponsor: Turku University Hospital

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.

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 Timeline

• Study Start: 1997-03
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Last Update Submitted: 2014-06-27
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

Inclusion Criteria

• benign indication for hysterectomy

Exclusion Criteria

• abnormal Pap smear

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subtotal abdominal hysterectomy	Subtotal abdominal hysterectomy	107 women
Total abdominal hysterectomy	Subtotal abdominal hysterectomy	105 women

Primary Outcome Measures

Name	Time	Method
Number of participants having subjective symptoms after hysterectomy	19 years and 33 years postoperatively	Urinary and bowel symptoms assessed with questionnaires and Visual Analog Scale.; Sexual symptoms assessed with questionnaire.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Turku University Hospital; 🇫🇮 Turku, Finland