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

Phase 4

Completed

• Conditions: Hysterectomy
• Interventions: Procedure: Total abdominal hysterectomy; Procedure: Subtotal abdominal hysterectomy

• Registration Number: NCT00876057
• Lead Sponsor: University Hospital, Linkoeping

Brief 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.

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 Timeline

• Study Start: 1998-03
• Primary Completion: 2004-04
• Study Completion: 2005-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-08
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TH	Total abdominal hysterectomy	Total hysterectomy
SH	Subtotal abdominal hysterectomy	Subtotal hysterectomy

Primary Outcome Measures

Name	Time	Method
Psychological well-being	One year after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Höglandssjukhuset i Eksjö; 🇸🇪 Eksjö, Sweden

Ryhov Central Hospital; 🇸🇪 Jönköping, Sweden

County Hospital in Kalmar; 🇸🇪 Kalmar, Sweden

Vrinnevi Hospital; 🇸🇪 Norrköping, Sweden

Capio Läkargruppen; 🇸🇪 Örebro, Sweden

Värnamo County Hospital; 🇸🇪 Värnamo, Sweden

Motala Counbty Hospital; 🇸🇪 Motala, Sweden