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
  Purpose

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.


Condition Intervention
Hysterectomy
Procedure: day-case laparoscopic supracervical hysterectomy
Procedure: inpatient LSH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 49
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: inpatient LSH
LSH means laparoscopic supracervical hysterectomy
Procedure: inpatient LSH
patients discharged home the day after the operation
Other Name: 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 Name: day surgery, day-case, outpatient surgery

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127243

Locations
Norway
Oslo University Hospital, Ullevål
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Jelena Kisic-Trope, MD, Msc Oslo University Hospital, Ullevål
  More Information

No publications provided

Responsible Party: Jelena Kisic-Trope, Oslo university Hospital, Ullevål
ClinicalTrials.gov Identifier: NCT01127243     History of Changes
Other Study ID Numbers: S-08447a
Study First Received: May 19, 2010
Last Updated: May 19, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Hysterectomy
laparoscopy
day-case surgery
quality of life
Ambulatory Surgical Procedures

ClinicalTrials.gov processed this record on August 18, 2014