Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

Hysterectomy Clinical Trial

Official title:

Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127243
• Other study ID #: S-08447a
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: May 19, 2010
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• day-case laparoscopic supracervical hysterectomy
patients discharged home the same day of the operation
• inpatient LSH
patients discharged home the day after the operation

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction with the length of stay in the hospital	satisfaction was measured on a 10-point visual analogue scale	on the 7th postoperative day	No
Secondary	health-related quality of life	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	measured on days 1, 2, 4 and 7 following surgery	No