Clinical trial NCT01127243: Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
Official title: Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Keywords: Hysterectomy
laparoscopy
day-case surgery
quality of life
Ambulatory Surgical Procedures
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 49
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: satisfaction with the length of stay in the hospital
timeFrame: on the 7th postoperative day
Secondary outcomes:
measure: health-related quality of life
timeFrame: measured on days 1, 2, 4 and 7 following surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
Study officials:
affiliation: Oslo University Hospital, Ullevål
name: Jelena Kisic-Trope, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References: