Clinical Follow up After Subtotal and Total Hysterectomy

Abdominal Hysterectomy (& Wertheim) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166749
• Other study ID #: ETMK:41/180/2010
• Status: Completed
• Phase: N/A
• First received: June 16, 2014
• Last updated: June 27, 2014
• Start date: March 1997
• Est. completion date: December 2011

Study information

• Verified date: June 2014
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• benign indication for hysterectomy

Exclusion Criteria:

• abnormal Pap smear

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abdominal Hysterectomy (& Wertheim)

Intervention

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.

Locations

Country	Name	City	State
Finland	Department of Obstetrics and Gynecology, Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Objective evaluation of pelvic organ prolapse after hysterectomy	Gynecological examination and measurements using pelvic organ prolapse quantification system (POP-Q) to find out the number of participants having prolapse.	33 years postoperatively	No