Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

May 19, 2010 updated by: Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital, Ullevål

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: inpatient LSH
LSH means laparoscopic supracervical hysterectomy
Procedure: inpatient LSH
patients discharged home the day after the operation
Other Names:
  • inpatient, overnight stay
EXPERIMENTAL: Day-case LSH
LSH means laparoscopic supracervical hysterectomy
Procedure: day-case laparoscopic supracervical hysterectomy
patients discharged home the same day of the operation
Other Names:
  • day surgery, day-case, outpatient surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction with the length of stay in the hospital
Time Frame: on the 7th postoperative day
satisfaction was measured on a 10-point visual analogue scale
on the 7th postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health-related quality of life
Time Frame: measured on days 1, 2, 4 and 7 following surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Jelena Kisic-Trope, MD, Msc, Oslo University Hospital, Ullevål

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (ESTIMATE)

May 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2010

Last Update Submitted That Met QC Criteria

May 19, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-08447a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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