Laparoscopic Hysterectomy - Outpatient Versus Inpatient Regimen

NCT ID: NCT02933047

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-04-30

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.

Conditions

Outpatient Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Outpatient LH

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

Group Type: ACTIVE_COMPARATOR

Total laparoscopic hysterectomy

Intervention Type: PROCEDURE

Inpatient LH

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

Group Type: PLACEBO_COMPARATOR

Total laparoscopic hysterectomy

Intervention Type: PROCEDURE

Interventions

Total laparoscopic hysterectomy

Intervention Type: PROCEDURE

Total laparoscopic hysterectomy

Intervention Type: PROCEDURE

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulla J. Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Arhus University

References

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.

Reference Type: DERIVED

PMID: 31148146 (View on PubMed)

Other Identifiers

1-16-02-212-13

Identifier Type: OTHER

Identifier Source: secondary_id

5711674

Identifier Type: -

Identifier Source: org_study_id