Clinical Trials Directory

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

TypeNameDescription
PROCEDUREday-case laparoscopic supracervical hysterectomypatients discharged home the same day of the operation
PROCEDUREinpatient LSHpatients 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.