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

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876057
• Other study ID #: 2009-0102
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2009
• Last updated: June 8, 2012
• Start date: March 1998
• Est. completion date: April 2005

Study information

• Verified date: June 2012
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2005
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• Total abdominal hysterectomy
Total abdominal hysterectomy
• Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomy

Locations

Country	Name	City	State
Sweden	Höglandssjukhuset i Eksjö	Eksjö
Sweden	Ryhov Central Hospital	Jönköping
Sweden	County Hospital in Kalmar	Kalmar
Sweden	Motala Counbty Hospital	Motala
Sweden	Vrinnevi Hospital	Norrköping
Sweden	Capio Läkargruppen	Örebro
Sweden	Värnamo County Hospital	Värnamo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological well-being		One year after surgery	No
Secondary	Recovery of general well-being		Five weeks after surgery	No
Secondary	Sexuality		One year	No
Secondary	Pelvic organ prolapse (anatomical)	Follow-up median eleven years after the initial hysterectomy. Clinical investigation including POP-Q.	7-14 years	No
Secondary	Patient reported symptoms of pelvic organ dysfunction	Follow-up median eleven years after the initial hysterectomy. Questionnaire (Pelvic Floor Dysfuntion Inventoy).	7-14 years	No