HysterectomyNCT00181311
Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy
An observational study of Hysterectomy, run by Maasland Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to Oct 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Benign indication for undergoing of a hysterectomy
- Written informed consent of the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maasland Hospital
Sittard, Limburg, 6130 MB
Erik Jan Sollie, MD, +31(0)464597787
Martine Wassen
About this study
Official title: Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy
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.
Read the 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.
- Conditions
- Hysterectomy
- Being tested
- hysterectomy
- Keywords
- vaginal hysterectomy, abdominal hysterectomy, complications, physical well being, mental well being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Maasland Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Erik Jan Sollie, MD, Study chair, Maasland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181311
- Sponsor's protocol ID
- 05-P-26
- Status last verified
- Aug 2005
- First submitted
- 10 Sep 2005
- Last updated
- 26 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT00181311
- Acronym / sponsor ID
- 05-P-26
- Conditions
- Hysterectomy
- Keywords
- vaginal hysterectomy, abdominal hysterectomy, complications, physical well being, mental well being
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Maasland HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Oct 2006
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Benign indication for undergoing of a hysterectomy
- Written informed consent of the patient
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysterectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Jan Sollie, MD study chair
Maasland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by Maasland Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Jan Sollie, MD (+31(0)464597787, e.sollie@orbisconcern.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2006.