Laparoscopic Hysterectomy - Outpatient Versus Inpatient Regimen (LH)

January 24, 2018 updated by: University of Aarhus

Laparoscopic Hysterectomy - A Randomized Controlled Trial on Outpatient Versus Inpatient Regimen

Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to hysterectomy. It is a safe procedure with low rates of complications and readmissions. Increasing evidence indicates that LH may be suitable for an outpatient setting but this may impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient care to day case surgery might influence readmission rates and postoperative physical activity. No data are available on the current length of sick leave in Danish patients after hysterectomy, and the effects of outpatient surgery on this parameter are difficult to predict. A randomized controlled trial of LH performed as an outpatient procedure compared with today's inpatient standard will provide a firm platform for future planning of routine treatment of patients with need of hysterectomy for benign indications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hysterectomy is the most frequent gynecological operation world wide and the indication is often benign. The women are healthy and young with a median age below 50 years. In Denmark, hysterectomy is performed as an inpatient procedure with a median hospitalization of 1 day. Hysterectomies in Denmark are distributed by 45% abdominal hysterectomies (AH), 35% vaginal hysterectomies (VH) and 20% laparoscopic hysterectomies (LH). There is no final consensus whether VH or LH should be recommended as first choice but LH is gaining more and more acceptance. Increasing evidence indicates that LH may be suitable for an outpatient setting. Data seem to assure that outpatient LH is feasible but patient's satisfaction in this setting remains an open question. A detailed analysis of data from a Norwegian study indicates that patients reporting dissatisfaction with the early discharge amounts to 25-38%. Such a decrease in patient's satisfaction would present a significant problem, and a randomized controlled study of sufficient size with focus on this aspect is therefore needed.

Recommendations on postoperative sick leave vary considerably, due to lack of evidence-based guidelines and no firm data are available on the relation between outpatient treatment and sick leave in gynecology.

This randomized controlled study attempt to examine outpatient LH and patient satisfaction and related subject as readmissions and complications, time to return to work, physical activity in the recuperation period and an overall socioeconomic calculation of the costs of LH in an in- and outpatient setting.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

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

18 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal women below 56 years who is in need of a hysterectomy for benign conditions.
  • Additional surgery is allowed in the gynecological area.
  • BMI and working status is NOT exclusion criteria's.

Exclusion Criteria:

  • Unable to read and write Danish to answer questionnaires.
  • Unable to walk to carry a pedometer.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Outpatient LH
Patients in the intervention group are discharged within 6 to 8 hours after total laparoscopic hysterectomy.
Procedure: Total laparoscopic hysterectomy
Placebo Comparator: Inpatient LH
Patients in the control group follow regular hospitalization and are discharged within 24 hours after total laparoscopic hysterectomy.
Procedure: Total laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with length of stay after total laparoscopic hysterectomy.
Time Frame: 2 weeks after surgery
Difference in satisfaction with length of stay between intervention group and placebo measured on a visual analogue scale from 0 to 10 with 10 being most satisfied and presented on an international unit scale.
2 weeks after surgery
Patient satisfaction and quality of life
Time Frame: 4 weeks from date of surgery
The difference in patient satisfaction between inpatient and outpatient laparoscopic hysterectomy 4 weeks from surgery measured by the European Quality of life questionnaire in 5 dimensions (EQ5D) and presented as an index number.
4 weeks from date of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and pattern of complications and readmissions for in- and outpatient LH.
Time Frame: 4 weeks from the date of surgery
Number and type of complications found in medical records. Outcome will be presented as odds ratios and compared using chi2 measurement.
4 weeks from the date of surgery
Physical activity in the recovery period after in- and outpatient LH.
Time Frame: 4 weeks from the date of surgery
Daily walking distance in steps per day. Data will be presented as repeated measurement and the groups are compared by pairwise comparison.
4 weeks from the date of surgery
Return to work after in- and outpatient LH.
Time Frame: 6 month from the date of surgery
Date of return to work after surgery. The sick-leave is 14 days. When the sick-leave is more than 14 days it will be part of a socioeconomic analysis of lost work capacity and time spend on consultations. The difference between the groups will be measured in QALY's (Quality adjusted life year) and monetary values.
6 month from the date of surgery

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Ulla J. Christiansen, MD, Arhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5711674
  • 1-16-02-212-13 (Other Identifier: Danish Dataprotection Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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