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

University Hospital, Linkoeping

Status and phase: Completed; Phase 4

Conditions: Hysterectomy

Treatments: Procedure: Total abdominal hysterectomy; Procedure: Subtotal abdominal hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00876057

2009-0102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

TH

Active Comparator group

Description:

Total hysterectomy

Treatment:

Procedure: Total abdominal hysterectomy

SH

Active Comparator group

Description:

Subtotal hysterectomy

Treatment:

Procedure: Subtotal abdominal hysterectomy