Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.NCT02150200
Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.
A study testing shorter hospitalization stay and questionnaires in people with Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease., run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000 hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The percentage of hysterectomies performed laparoscopically is increasing. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.
- What is being tested?
- shorter hospitalization stay and questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Feb 2015
- Phase
- Interventional
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 35 and 70.
- affiliation to a social security system
- signed informed consent form
- disponibility of an responsible and valid accompanying person during 48 hours
- home situation, less than one hour to go to an adapted structure of care
- access to a phone
Who cannot join
- comorbidity which will automatically increase the period of hospital stay
- contraindication in laparoscopy
- difficulty to understand the protocol
- no social security cover
Trial locations and contacts
1 site in 1 country.
Chérif YOUSSEF AZER AKLADIOS, Doctor contact
France1 site
Hôptaux Universitaires de Strasbourg, Département de Gynécologie-Obstétrique
Strasbourg, 67098
Chérif YOUSSEF AZER AKLADIOS, Doctor, 3 88 12 74 83 ext. 0033, Cherif.YOUSSEF.AZER@chru-strasbourg.fr
About this study
Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000 hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The percentage of hysterectomies performed laparoscopically is increasing. The advantage of laparoscopy include fewer infections, less operative pain, faster recovery time and shorter hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy reduced to 3-4 days.
The study hypothesis is that a shorter postoperative stay does not decrease the quality of life of the patients.
This study will compare the evolution of quality of life (with a questionnaire concerning measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3 days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.
- Being tested
- shorter hospitalization stay, questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shorter hospitalization stayOther
questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| A group : Conventional hospitalization | Other | Patients discharged after 3 days hospital stay after laparoscopic hysterectomy Receives: Other: questionnaires |
| B group : shorter stay | Experimental | Patients going home within 24 hours discharged the first day after laparoscopic hysterectomy. Receives: Other: shorter hospitalization stay; Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessed by the Euroqol EQ-5D
Measure of quality of life with a questionnaire concerning health related quality of life (the Euroqol EQ-5D).The patients will complete the questionnaire at up to 30th days after the laparoscopic hysterectomy.
Measured: up to 30th days after the laparoscopic hysterectomy.
Secondary outcomes (8)
Quality of life with assessed by the short SF-36 score (the 36 items Short Form Health Survey). in pre-operative time and 30 days after the hysterectomy.
Measured: In pre-operative time and 30 days after the hysterectomy.
Patient satisfaction
Measured: Patient satisfaction assessed one month after intervention
Evaluation of pain by Visual Analog Scale for Pain and by analgesic drugs consumption
Measured: the day of intervention, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days and 30 days after intervention
Anxiety assessment by the State trait anxiety inventory forme Y-A
Measured: before intervention, the firt day, the second day, the third day after intervention, one week after intervention and one month after intervention.
Patient recovery and discharge after intervention assessed by Post-Anaesthetic Discharge Scoring System (PADSS score).
Measured: 8 hours after laparoscopic surgery
Comparison between a hospital stay of 3-4 days after laparoscopic hysterectomy costs and hospital stay of 1day after laparoscopic hysterectomy costs from the day of intervention until one month after intervention.
The assessment will take into account any case of rehospitalization
Measured: each day from the date of intervention untill one month after intervention.
Perioperative morbidity
Measured: from intervention untill one month after intervention
Number of rehospitalization
Measured: one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.Studies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150200
- Sponsor's protocol ID
- 5717
- Status last verified
- Jul 2014
- First submitted
- 26 May 2014
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.
- ClinicalTrials.gov ID
- NCT02150200
- Acronym / sponsor ID
- 5717
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (estimated)
- First posted
- 29 May 2014 (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.
Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000 hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The percentage of hysterectomies performed laparoscopically is increasing. The advantage of laparoscopy include fewer infections, less operative pain, faster recovery time and shorter hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy reduced to 3-4 days.
The study hypothesis is that a shorter postoperative stay does not decrease the quality of life of the patients.
This study will compare the evolution of quality of life (with a questionnaire concerning measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3 days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group : Conventional hospitalization | Other | Other: questionnairesPatients discharged after 3 days hospital stay after laparoscopic hysterectomy |
| B group : shorter stay | Experimental | Other: shorter hospitalization stay, Other: questionnairesPatients going home within 24 hours discharged the first day after laparoscopic hysterectomy. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age between 35 and 70.
- affiliation to a social security system
- signed informed consent form
- disponibility of an responsible and valid accompanying person during 48 hours
- home situation, less than one hour to go to an adapted structure of care
Key exclusion criteria (4 listed)
- comorbidity which will automatically increase the period of hospital stay
- contraindication in laparoscopy
- difficulty to understand the protocol
- no social security cover
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 |
|---|---|---|
| shorter hospitalization stay | Other | B group : shorter stay |
| questionnaires | Other | A group : Conventional hospitalization, B group : shorter stay |
Primary outcome
Quality of life assessed by the Euroqol EQ-5D
Time frame: up to 30th days after the laparoscopic hysterectomy.
Measure of quality of life with a questionnaire concerning health related quality of life (the Euroqol EQ-5D).The patients will complete the questionnaire at up to 30th days after the laparoscopic hysterectomy.
8 secondary outcomes
Quality of life with assessed by the short SF-36 score (the 36 items Short Form Health Survey). in pre-operative time and 30 days after the hysterectomy.
Time frame: In pre-operative time and 30 days after the hysterectomy.
Patient satisfaction
Time frame: Patient satisfaction assessed one month after intervention
Evaluation of pain by Visual Analog Scale for Pain and by analgesic drugs consumption
Time frame: the day of intervention, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days and 30 days after intervention
Anxiety assessment by the State trait anxiety inventory forme Y-A
Time frame: before intervention, the firt day, the second day, the third day after intervention, one week after intervention and one month after intervention.
Patient recovery and discharge after intervention assessed by Post-Anaesthetic Discharge Scoring System (PADSS score).
Time frame: 8 hours after laparoscopic surgery
Comparison between a hospital stay of 3-4 days after laparoscopic hysterectomy costs and hospital stay of 1day after laparoscopic hysterectomy costs from the day of intervention until one month after intervention.
Time frame: each day from the date of intervention untill one month after intervention.
Perioperative morbidity
Time frame: from intervention untill one month after intervention
Number of rehospitalization
Time frame: one month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
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.
Chérif YOUSSEF AZER AKLADIOS, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shorter hospitalization stay and questionnaires in people with Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease., run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 4 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 4 Jul 2014. 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 France. 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 Chérif YOUSSEF AZER AKLADIOS, Doctor (3 88 12 74 83 ext. 0033, Cherif.YOUSSEF.AZER@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessed by the Euroqol EQ-5D (time frame: up to 30th days after the laparoscopic hysterectomy.). It is what the study was designed to measure, not a finding.
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 4 Jul 2014.