Trials / Completed
CompletedNCT01127243
Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | day-case laparoscopic supracervical hysterectomy | patients discharged home the same day of the operation |
| PROCEDURE | inpatient LSH | patients discharged home the day after the operation |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2010-05-20
- Last updated
- 2010-05-20
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT01127243. Inclusion in this directory is not an endorsement.