Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02166749
Other study ID # ETMK:41/180/2010
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02296619 - The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy Phase 4
Completed NCT02362022 - The Effects of Morphine on Desflurane Consumption and Recovery Time Phase 4
Not yet recruiting NCT02259374 - Use of Tap Block in Patients After Hysterectomy N/A
Withdrawn NCT01622335 - Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy N/A
Completed NCT02086747 - Acetaminophen for Chronic Pain in Hysterectomy Phase 4
Completed NCT03064308 - The Assessment of the Feasibility of a Home Based Exercise Programme in the Older Patient Following Major Surgery N/A
Completed NCT02281487 - Hysterectomy for Benign Gynaecological Conditions With or Without Tubectomy N/A