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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Preben Kjolhede, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00876057
First received: April 3, 2009
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Hysterectomy
Procedure: Total abdominal hysterectomy
Procedure: Subtotal abdominal hysterectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Psychological well-being [ Time Frame: One year after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recovery of general well-being [ Time Frame: Five weeks after surgery ] [ Designated as safety issue: No ]
  • Sexuality [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Pelvic organ prolapse (anatomical) [ Time Frame: 7-14 years ] [ Designated as safety issue: No ]
    Follow-up median eleven years after the initial hysterectomy. Clinical investigation including POP-Q.

  • Patient reported symptoms of pelvic organ dysfunction [ Time Frame: 7-14 years ] [ Designated as safety issue: No ]
    Follow-up median eleven years after the initial hysterectomy. Questionnaire (Pelvic Floor Dysfuntion Inventoy).


Enrollment: 200
Study Start Date: March 1998
Study Completion Date: April 2005
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TH
Total hysterectomy
Procedure: Total abdominal hysterectomy
Total abdominal hysterectomy
Active Comparator: SH
Subtotal hysterectomy
Procedure: Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876057

Locations
Sweden
Höglandssjukhuset i Eksjö
Eksjö, Sweden, 57581
Ryhov Central Hospital
Jönköping, Sweden, 55185
County Hospital in Kalmar
Kalmar, Sweden, 39185
Motala Counbty Hospital
Motala, Sweden, 59185
Vrinnevi Hospital
Norrköping, Sweden, 601 82
Värnamo County Hospital
Värnamo, Sweden, 33185
Capio Läkargruppen
Örebro, Sweden, 70146
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Study Chair: Preben Kjölhede, MD, PhD University Hospital, Linköping
Study Director: Pär Persson, MD University Hospital, Linköping
  More Information

No publications provided

Responsible Party: Preben Kjolhede, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00876057     History of Changes
Other Study ID Numbers: 2009-0102
Study First Received: April 3, 2009
Last Updated: June 8, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
psychological well-being
recovery
time in hospital
sick-leave
complications
Sexual well-being

ClinicalTrials.gov processed this record on September 16, 2014