NCT00876057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

6.1 years

First QC Date

April 3, 2009

Last Update Submit

June 8, 2012

Conditions

Hysterectomy

Keywords

psychological well-beingrecoverytime in hospitalsick-leavecomplicationsSexual well-being

Outcome Measures

Primary Outcomes (1)

  • Psychological well-being

    One year after surgery

Secondary Outcomes (4)

  • Recovery of general well-being

    Five weeks after surgery

  • Sexuality

    One year

  • Pelvic organ prolapse (anatomical)

    7-14 years

  • Patient reported symptoms of pelvic organ dysfunction

    7-14 years

Study Arms (2)

TH

ACTIVE COMPARATOR

Total hysterectomy

Procedure: Total abdominal hysterectomy

SH

ACTIVE COMPARATOR

Subtotal hysterectomy

Procedure: Subtotal abdominal hysterectomy

Interventions

Total abdominal hysterectomyPROCEDURE

Total abdominal hysterectomy

TH
Subtotal abdominal hysterectomyPROCEDURE

Subtotal abdominal hysterectomy

SH

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Höglandssjukhuset i Eksjö

Eksjö, 57581, Sweden

Location

Ryhov Central Hospital

Jönköping, 55185, Sweden

Location

County Hospital in Kalmar

Kalmar, 39185, Sweden

Location

Motala Counbty Hospital

Motala, 59185, Sweden

Location

Vrinnevi Hospital

Norrköping, 601 82, Sweden

Location

Capio Läkargruppen

Örebro, 70146, Sweden

Location

Värnamo County Hospital

Värnamo, 33185, Sweden

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Preben Kjölhede, MD, PhD

    University Hospital, Linköping

    STUDY CHAIR

  • Pär Persson, MD

    University Hospital, Linköping

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

March 1, 1998

Primary Completion

April 1, 2004

Study Completion

April 1, 2005

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

SE(7)