Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01127243
First received: May 19, 2010
Last updated: NA
Last verified: June 2009
History: No changes posted

May 19, 2010
May 19, 2010
June 2008
June 2009   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hysterectomy
  • Procedure: day-case laparoscopic supracervical hysterectomy
    patients discharged home the same day of the operation
    Other Name: day surgery, day-case, outpatient surgery
  • Procedure: inpatient LSH
    patients discharged home the day after the operation
    Other Name: inpatient, overnight stay
  • Active Comparator: inpatient LSH
    LSH means laparoscopic supracervical hysterectomy
    Intervention: Procedure: inpatient LSH
  • Experimental: Day-case LSH
    LSH means laparoscopic supracervical hysterectomy
    Intervention: Procedure: day-case laparoscopic supracervical hysterectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:.

  • women requiring a hysterectomy for benign conditions

Exclusion Criteria:

  • 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,
  • 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
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01127243
S-08447a
No
Jelena Kisic-Trope, Oslo university Hospital, Ullevål
Oslo University Hospital
Not Provided
Principal Investigator: Jelena Kisic-Trope, MD, Msc Oslo University Hospital, Ullevål
Oslo University Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP