Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hysterectomy

Intervention / Treatment
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* Procedure: day-case laparoscopic supracervical hysterectomy
* Procedure: inpatient LSH


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: inpatient LSH<br>LSH means laparoscopic supracervical hysterectomy | Procedure: inpatient LSH<br>* patients discharged home the day after the operation<br>* Other names: inpatient, overnight stay;|
| Experimental: Day-case LSH<br>LSH means laparoscopic supracervical hysterectomy | Procedure: day-case laparoscopic supracervical hysterectomy<br>* patients discharged home the same day of the operation<br>* Other names: day surgery, day-case, outpatient surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction with the length of stay in the hospital | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysterectomy, laparoscopy, day-case surgery, quality of life, Ambulatory Surgical Procedures