NCT02933047

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Last Updated

January 26, 2018

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

October 21, 2013

Last Update Submit

January 24, 2018

Conditions

Outpatient Hysterectomy

Keywords

HysterectomyPatient satisfactionRehabilitationLaparoscopyReturn to workExercise

Outcome Measures

Primary Outcomes (2)

  • Satisfaction with length of stay after total laparoscopic hysterectomy.

    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

    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 Outcomes (3)

  • Incidence and pattern of complications and readmissions for in- and outpatient LH.

    4 weeks from the date of surgery

  • Physical activity in the recovery period after in- and outpatient LH.

    4 weeks from the date of surgery

  • Return to work after in- and outpatient LH.

    6 month from the date of surgery

Study Arms (2)

Outpatient LH

ACTIVE COMPARATOR

Patients in the intervention group are discharged within 6 to 8 hours after total laparoscopic hysterectomy.

Procedure: Total laparoscopic hysterectomy

Inpatient LH

PLACEBO COMPARATOR

Patients in the control group follow regular hospitalization and are discharged within 24 hours after total laparoscopic hysterectomy.

Procedure: Total laparoscopic hysterectomy

Interventions

Total laparoscopic hysterectomyPROCEDURE
Outpatient LH

Eligibility Criteria

Age18 Years - 56 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women below 56 years who is in need of a hysterectomy for benign conditions.
  • Additional surgery is allowed in the gynecological area.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31148146DERIVED

MeSH Terms

Conditions

Patient SatisfactionMotor Activity

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ulla J. Christiansen, MD

    Arhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2013

First Posted

October 14, 2016

Study Start

October 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 26, 2018

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share