Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

• Conditions: Hysterectomy

• Registration Number: NCT00181311
• Lead Sponsor: Maasland Hospital

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.

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.

Study Timeline

• Status Verified: 2005-08
• Study Start: 2005-08
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Study Completion: 2006-10
• Last Update Submitted: 2006-10-25
• Last Update Posted: 2006-10-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Maasland Hospital; 🇳🇱 Sittard, Limburg, Netherlands