Skip to main content
OpenTrials
Completed

NCT Number: NCT01127243

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Ullevål

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

day-case laparoscopic supracervical hysterectomy

Procedure

patients discharged home the same day of the operation

Other names: day surgery, day-case, outpatient surgery

inpatient LSH

Procedure

patients discharged home the day after the operation

Other names: inpatient, overnight stay

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 20, 2010
Registry last updated
May 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.