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Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00181311
Enrollment
200
Registered
2005-09-16
Start date
2005-08-31
Completion date
2006-10-31
Last updated
2006-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

Keywords

vaginal hysterectomy, abdominal hysterectomy, complications, physical well being, mental well being

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.

Interventions

PROCEDUREhysterectomy

Sponsors

Maasland Hospital
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Countries

Netherlands

Contacts

Primary ContactErik Jan Sollie, MD
e.sollie@orbisconcern.nl+31(0)464597787

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026