LH: Laparoscopic Hysterectomy - Outpatient Versus Inpatient Regimen

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT02933047

Collaborator

Aarhus University Hospital (Other)

204

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Outpatient Hysterectomy	Procedure: Total laparoscopic hysterectomy Procedure: Total laparoscopic hysterectomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Satisfaction with length of stay after total laparoscopic hysterectomy. [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.
Patient satisfaction and quality of life [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.

Secondary Outcome Measures

Incidence and pattern of complications and readmissions for in- and outpatient LH. [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.
Physical activity in the recovery period after in- and outpatient LH. [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.
Return to work after in- and outpatient LH. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 56 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.