Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
| Tracking Information | |||||
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| First Received Date ICMJE | May 19, 2010 | ||||
| Last Updated Date | May 19, 2010 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
satisfaction with the length of stay in the hospital [ Time Frame: on the 7th postoperative day ] [ Designated as safety issue: No ] satisfaction was measured on a 10-point visual analogue scale |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
health-related quality of life [ Time Frame: measured on days 1, 2, 4 and 7 following surgery ] [ Designated as safety issue: No ] 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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy | ||||
| Official Title ICMJE | Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy | ||||
| Brief 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. The null hypothesis was that there was no difference in satisfaction with length of hospital stay. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hysterectomy | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 49 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:.
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01127243 | ||||
| Other Study ID Numbers ICMJE | S-08447a | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jelena Kisic-Trope, Oslo university Hospital, Ullevål | ||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Oslo University Hospital | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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