Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
NCT ID: NCT01127243
Last Updated: 2010-05-20
Study Results
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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COMPLETED
NA
49 participants
INTERVENTIONAL
2008-06-30
2009-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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inpatient LSH
LSH means laparoscopic supracervical hysterectomy
inpatient LSH
patients discharged home the day after the operation
Day-case LSH
LSH means laparoscopic supracervical hysterectomy
day-case laparoscopic supracervical hysterectomy
patients discharged home the same day of the operation
Interventions
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day-case laparoscopic supracervical hysterectomy
patients discharged home the same day of the operation
inpatient LSH
patients discharged home the day after the operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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,
* 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.
FEMALE
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Oslo university Hospital, Ullevål
Principal Investigators
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Jelena Kisic-Trope, MD, Msc
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital, Ullevål
Locations
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Oslo University Hospital, Ullevål
Oslo, Oslo County, Norway
Countries
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Other Identifiers
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S-08447a
Identifier Type: -
Identifier Source: org_study_id
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