Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Maasland Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maasland Hospital
ClinicalTrials.gov Identifier:
NCT00181311
First received: September 10, 2005
Last updated: October 25, 2006
Last verified: August 2005
  Purpose

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.


Condition Intervention
Hysterectomy
Procedure: hysterectomy

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Maasland Hospital:

Estimated Enrollment: 200
Study Start Date: August 2005
Estimated Study Completion Date: October 2006
Detailed Description:

Hysterectomy is the most common major gynaecological operation performed worldwide.

The overall average rate of hysterectomy in the United States is 5.6 per 1000 women. There are three different procedures to perform a hysterectomy. The surgery can be approached abdominally, vaginally or as a laparoscopically assisted hysterectomy.

This study will contribute to the improvement of knowledge in short and long term complications and especially the prevalence of occult and subclinical haematomas and vaginal abscesses after abdominal or vaginal hysterectomy. The occurrence of short and long term complications will have an influence on the general well being of the patient. We will also evaluate the physical and mental well being of the patient after a hysterectomy.

After statistical analysis of the study outcome parameters, some conclusions can be drawn for the treatment policy after an abdominal or vaginal hysterectomy to reduce the complication rate and improve the general well being of our patients.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181311

Contacts
Contact: Erik Jan Sollie, MD +31(0)464597787 e.sollie@orbisconcern.nl

Locations
Netherlands
Maasland Hospital Recruiting
Sittard, Limburg, Netherlands, 6130 MB
Contact: Erik Jan Sollie, MD    +31(0)464597787      
Principal Investigator: Martine Wassen         
Sponsors and Collaborators
Maasland Hospital
Investigators
Study Chair: Erik Jan Sollie, MD Maasland Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181311     History of Changes
Other Study ID Numbers: 05-P-26
Study First Received: September 10, 2005
Last Updated: October 25, 2006
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Maasland Hospital:
vaginal hysterectomy
abdominal hysterectomy
complications
physical well being
mental well being

ClinicalTrials.gov processed this record on August 26, 2014