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Completed

NCT Number: NCT02933047

Laparoscopic Hysterectomy - 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.

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Key information

Conditions

Outpatient Hysterectomy Behavior Health Behavior Motor Activity Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year–56 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total laparoscopic hysterectomy

Procedure

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: LH

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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