Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

NCT ID: NCT00181311

Last Updated: 2006-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Hysterectomy

Keywords

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vaginal hysterectomy abdominal hysterectomy complications physical well being mental well being

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maasland Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Erik Jan Sollie, MD

Role: STUDY_CHAIR

Maasland Hospital

Locations

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Maasland Hospital

Sittard, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Erik Jan Sollie, MD

Role: CONTACT

Phone: +31(0)464597787

Email: [email protected]

Facility Contacts

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Erik Jan Sollie, MD

Role: primary

Other Identifiers

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05-P-26

Identifier Type: -

Identifier Source: org_study_id