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

U

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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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