HysterectomyNCT01127243
Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
A study testing day-case laparoscopic supracervical hysterectomy and inpatient LSH in people with Hysterectomy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine if women subjected to laparoscopic supracervical hysterectomy in a day-case setting would be less satisfied with the length of hospital stay when compared with women who had an overnight stay following their surgical procedure. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- day-case laparoscopic supracervical hysterectomy and inpatient LSH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2008to Jun 2009
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women requiring a hysterectomy for benign conditions
Who cannot join
- previous history of cervical dysplasia, an abnormal smear test within the last two to three years,
- abnormal histology or cytology at endometrial sampling,
- a history of endometriosis,
- advanced endometriosis diagnosed intra-operatively,
- previous major abdominal or pelvic surgery (patients with previous caesarean section were considered as eligible),
- a mental disorder or somatic disease that would interfere with a normal recovery pattern such as substance dependence disorder,
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- psychosis, or American Society of Anaesthesiologists (ASA) rating 3 and 4 patients, and
- inability to understand and execute oral and written Norwegian language.
- women were also excluded from the study if they did not have an adult carer (a relative or a friend) staying with them during the first night after discharge; or they were living or staying at a hotel more than an hour's drive from the hospital; and if they did not have access to a telephone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
The purpose of this study is to determine if women subjected to laparoscopic supracervical hysterectomy in a day-case setting would be less satisfied with the length of hospital stay when compared with women who had an overnight stay following their surgical procedure. The null hypothesis was that there was no difference in satisfaction with length of hospital stay.
Read the detailed description
Objective: To determine whether women having day-case laparoscopic supracervical hysterectomy (LSH) are as satisfied with the length of stay in hospital as women who stay overnight following the procedure.
Design: randomised controlled trial (RCT).
Setting: Ulleval university hospital, Oslo, Norway.
Population: 49 women scheduled for LSH were enrolled and 45 patients completed the study (22 in the inpatient group and 23 in the day-case group).
Methods: Women were randomised to either day-case care or overnight hospital stay following a routine supracervical hysterectomy. The primary outcome measure was satisfaction with the length of stay in the hospital (measured on a 10-point visual analogue scale) and secondary measures were health-related quality of life (measured using the EuroQol EQ5D), anxiety (measured using the State-Trait Anxiety Inventory for Adults (STAI) and general questions about their experiences of having the operation. Readmissions, prolonged hospitalisations, complications and any contact with a health professional after discharge were also recorded. Measures were taken on the day of surgery (postoperatively), and on days 1, 2, 4 and 7 following surgery. The data were analysed based on an intention to treat.
- Conditions
- Hysterectomy
- Being tested
- day-case laparoscopic supracervical hysterectomy, inpatient LSH
- Keywords
- Hysterectomy, laparoscopy, day-case surgery, quality of life, Ambulatory Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
day-case laparoscopic supracervical hysterectomyProcedure or surgery
Also called day surgery, day-case, outpatient surgery
patients discharged home the same day of the operation
inpatient LSHProcedure or surgery
Also called inpatient, overnight stay
patients discharged home the day after the operation
| Study group | Role | What they receive |
|---|---|---|
| inpatient LSH | Active comparator | LSH means laparoscopic supracervical hysterectomy Receives: Procedure: inpatient LSH |
| Day-case LSH | Experimental | LSH means laparoscopic supracervical hysterectomy Receives: Procedure: day-case laparoscopic supracervical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction with the length of stay in the hospital
satisfaction was measured on a 10-point visual analogue scale
Measured: on the 7th postoperative day
Secondary outcomes (1)
health-related quality of life
health-related quality of life (measured using the EuroQol EQ5D), anxiety (measured using the State-Trait Anxiety Inventory for Adults (STAI) and general questions about their experiences of having the operation. Readmissions, prolonged hospitalisations, complications and any contact with a health professional after discharge were also recorded
Measured: measured on days 1, 2, 4 and 7 following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jelena Kisic-Trope, MD, Msc, Principal investigator, Oslo University Hospital, Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127243
- Sponsor's protocol ID
- S-08447a
- Status last verified
- Jun 2009
- First submitted
- 19 May 2010
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
- ClinicalTrials.gov ID
- NCT01127243
- Acronym / sponsor ID
- S-08447a
- Conditions
- Hysterectomy
- Keywords
- Hysterectomy, laparoscopy, day-case surgery, quality of life, Ambulatory Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 May 2010 (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 determine if women subjected to laparoscopic supracervical hysterectomy in a day-case setting would be less satisfied with the length of hospital stay when compared with women who had an overnight stay following their surgical procedure. The null hypothesis was that there was no difference in satisfaction with length of hospital stay.
Detailed description
Objective: To determine whether women having day-case laparoscopic supracervical hysterectomy (LSH) are as satisfied with the length of stay in hospital as women who stay overnight following the procedure.
Design: randomised controlled trial (RCT).
Setting: Ulleval university hospital, Oslo, Norway.
Population: 49 women scheduled for LSH were enrolled and 45 patients completed the study (22 in the inpatient group and 23 in the day-case group).
Methods: Women were randomised to either day-case care or overnight hospital stay following a routine supracervical hysterectomy. The primary outcome measure was satisfaction with the length of stay in the hospital (measured on a 10-point visual analogue scale) and secondary measures were health-related quality of life (measured using the EuroQol EQ5D), anxiety (measured using the State-Trait Anxiety Inventory for Adults (STAI) and general questions about their experiences of having the operation. Readmissions, prolonged hospitalisations, complications and any contact with a health professional after discharge were also recorded. Measures were taken on the day of surgery (postoperatively), and on days 1, 2, 4 and 7 following surgery. The data were analysed based on an intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inpatient LSH | Active comparator | Procedure: inpatient LSHLSH means laparoscopic supracervical hysterectomy |
| Day-case LSH | Experimental | Procedure: day-case laparoscopic supracervical hysterectomyLSH means laparoscopic supracervical hysterectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women requiring a hysterectomy for benign conditions
Key exclusion criteria (9 listed)
- previous history of cervical dysplasia, an abnormal smear test within the last two to three years,
- abnormal histology or cytology at endometrial sampling,
- a history of endometriosis,
- advanced endometriosis diagnosed intra-operatively,
- previous major abdominal or pelvic surgery (patients with previous caesarean section were considered as eligible),
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 |
|---|---|---|
| day-case laparoscopic supracervical hysterectomyAlso: day surgery, day-case, outpatient surgerypatients discharged home the same day of the operation | Procedure or surgery | Day-case LSH |
| inpatient LSHAlso: inpatient, overnight staypatients discharged home the day after the operation | Procedure or surgery | inpatient LSH |
Primary outcome
satisfaction with the length of stay in the hospital
Time frame: on the 7th postoperative day
satisfaction was measured on a 10-point visual analogue scale
1 secondary outcome
health-related quality of life
Time frame: measured on days 1, 2, 4 and 7 following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2010.
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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.
Jelena Kisic-Trope, MD, Msc principal investigator
Oslo University Hospital, Ullevål
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing day-case laparoscopic supracervical hysterectomy and inpatient LSH in people with Hysterectomy, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 20 May 2010. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction with the length of stay in the hospital (time frame: on the 7th postoperative day). 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 20 May 2010.