Psychological Well-being, Recovery and Sexuality After Total and Subtotal Hysterectomy

June 8, 2012 updated by: Preben Kjolhede, University Hospital, Linkoeping

Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.

The purpose of this study is to determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy.

Se also Detailed Description for additional study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An additional study study based on the material in original study started in april 2011. The purpose of this study is to investigate the development of pelvis organ prolapse in the long term (median eleven years after hysterectomy and by questionnaires, Pelvic-floor Distress Inventory SF-20 analyze if patient reported symptoms regarding urinary-and bowels functions differs regarding the method of hysterectomy.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Eksjö, Sweden, 57581
        • Höglandssjukhuset i Eksjö
      • Jönköping, Sweden, 55185
        • Ryhov Central Hospital
      • Kalmar, Sweden, 39185
        • County Hospital in Kalmar
      • Motala, Sweden, 59185
        • Motala Counbty Hospital
      • Norrköping, Sweden, 601 82
        • Vrinnevi Hospital
      • Värnamo, Sweden, 33185
        • Värnamo County Hospital
      • Örebro, Sweden, 70146
        • Capio Läkargruppen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primarily uterine fibroids with bleeding disturbance or mechanical symptoms but other benign disorders were hysterectomy was recommended were also eligible
  • After surgery at least one ovary preserved.
  • Informed verbal and written consent
  • Proficiency in Swedish

Exclusion Criteria:

  • Malignancy in the genital organs.
  • Previous or present cervical dysplasia.
  • Rapidly growing fibroids where malignancy could not be ruled out
  • Preoperative treatment with GnRH analogues.
  • Postmenopausal women without hormone therapy
  • Severe psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TH
Total hysterectomy
Procedure: Total abdominal hysterectomy
Total abdominal hysterectomy
Active Comparator: SH
Subtotal hysterectomy
Procedure: Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychological well-being
Time Frame: One year after surgery
One year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of general well-being
Time Frame: Five weeks after surgery
Five weeks after surgery
Sexuality
Time Frame: One year
One year
Pelvic organ prolapse (anatomical)
Time Frame: 7-14 years
Follow-up median eleven years after the initial hysterectomy. Clinical investigation including POP-Q.
7-14 years
Patient reported symptoms of pelvic organ dysfunction
Time Frame: 7-14 years
Follow-up median eleven years after the initial hysterectomy. Questionnaire (Pelvic Floor Dysfuntion Inventoy).
7-14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Study Chair: Preben Kjölhede, MD, PhD, University Hospital, Linköping
  • Study Director: Pär Persson, MD, University Hospital, Linköping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 8, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009-0102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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