Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy
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|ClinicalTrials.gov Identifier: NCT00181311|
Recruitment Status : Unknown
Verified August 2005 by Maasland Hospital.
Recruitment status was: Recruiting
First Posted : September 16, 2005
Last Update Posted : October 26, 2006
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 or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Defined Population|
|Official Title:||Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy|
|Study Start Date :||August 2005|
|Estimated Study Completion Date :||October 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181311
|Contact: Erik Jan Sollie, MD||+31(0)firstname.lastname@example.org|
|Sittard, Limburg, Netherlands, 6130 MB|
|Contact: Erik Jan Sollie, MD +31(0)464597787|
|Principal Investigator: Martine Wassen|
|Study Chair:||Erik Jan Sollie, MD||Maasland Hospital|