NCT00181311

Brief Summary

The purpose of this study is to evaluate the short and long term complications after an abdominal or vaginal hysterectomy and to detect the prevalence of occult/subclinical haematomas and vaginal cuff abscesses and the postoperative course of these. The investigators will also evaluate the physical and mental well being after a hysterectomy with a questionnaire and correlate these results with the occurrence of complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

October 26, 2006

Status Verified

August 1, 2005

First QC Date

September 10, 2005

Last Update Submit

October 25, 2006

Conditions

Hysterectomy

Keywords

vaginal hysterectomyabdominal hysterectomycomplicationsphysical well beingmental well being

Interventions

hysterectomyPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Benign indication for undergoing of a hysterectomy
  • Written informed consent of the patient

You may not qualify if:

  • Inability to undergo an operation due to high surgical or anaesthetic risk
  • Malignancy as indication for the hysterectomy
  • Patients with an enterocele or rectocele and who need prolapse surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maasland Hospital

Sittard, Limburg, 6130 MB, Netherlands

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Erik Jan Sollie, MD

    Maasland Hospital

    STUDY CHAIR

Central Study Contacts

Erik Jan Sollie, MD

CONTACT

+31(0)464597787e.sollie@orbisconcern.nl

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

August 1, 2005

Study Completion

October 1, 2006

Last Updated

October 26, 2006

Record last verified: 2005-08

Locations

NL(1)