Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

Hysterectomy Clinical Trial

Official title:

Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00181311
• Other study ID #: 05-P-26
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2005
• Last updated: October 25, 2006
• Start date: August 2005
• Est. completion date: October 2006

Study information

• Verified date: August 2005
• Source: Maasland Hospital
• Contact: Erik Jan Sollie, MD
• Phone: +31(0)464597787
• Email: e.sollie[@]orbisconcern.nl
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• hysterectomy

Locations

Country	Name	City	State
Netherlands	Maasland Hospital	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maasland Hospital

Country where clinical trial is conducted

Netherlands,