Clinical trial NCT02933047: Laparoscopic Hysterectomy - Outpatient Versus Inpatient Regimen
Official title: Laparoscopic Hysterectomy - A Randomized Controlled Trial on Outpatient Versus Inpatient Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outpatient Hysterectomy
Keywords: Hysterectomy
Patient satisfaction
Rehabilitation
Laparoscopy
Return to work
Exercise
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2016-10-14
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Satisfaction with length of stay after total laparoscopic hysterectomy.
timeFrame: 2 weeks after surgery
measure: Patient satisfaction and quality of life
timeFrame: 4 weeks from date of surgery
Secondary outcomes:
measure: Incidence and pattern of complications and readmissions for in- and outpatient LH.
timeFrame: 4 weeks from the date of surgery
measure: Physical activity in the recovery period after in- and outpatient LH.
timeFrame: 4 weeks from the date of surgery
measure: Return to work after in- and outpatient LH.
timeFrame: 6 month from the date of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Arhus University
name: Ulla J. Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christiansen UJ, Kruse AR, Olesen PG, Lauszus FF, Kesmodel US, Forman A. Outpatient vs inpatient total laparoscopic hysterectomy: A randomized controlled trial. Acta Obstet Gynecol Scand. 2019 Nov;98(11):1420-1428. doi: 10.1111/aogs.13670. Epub 2019 Jul 15.