A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy

February 1, 2019 updated by: Päivi Päkarinen, Helsinki University Central Hospital

A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy.

Factors affecting to length of hospital stay after fast-track recovery program in laparoscopic hysterectomy compared to conventional recovery program

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Factors affecting to length of hospital stay after laparoscopic hysterectomy in fast-track recovery program group compared to conventional recovery group.

The pimary outcome is time to discharge from the end of operation to discharge.

The second outcomes are amount of opioid used and NSAID, postoperative paine, nousea and vomiting, patients satisfaction, anxiety and stress-coping test, operative bleeding, operative time, postoperative complications, the cost of the laparoscopic hysterectomy.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00140
        • Päivi Pakarinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • uterine size less than uterine size at 14 weeks of pregnancy
  • at list one friend or family available to care to care after discharge.

Exclusion criteria:

  • endometriosis
  • contraindications to any of medications used in the study (oxycodone, ketoprofen, or paracetamol)
  • language difficulties (inability to understand and speak Finnish or Swedish)
  • age older that 70 years
  • mental health disability that limit autonomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fast-track recovery program

Pre-operative Verbal and video information Tobacco cessation Daily physical activity Light meal 6 hours and clear liquids up to 2 hours before surgery No bowel preparation A warm blanket Premedication paracetamol 1g and tematsepam 20mg

Intraoperatively For nausea and voimiting dexamethasone 10mg, dehydrobensperidol 1mg and ondancetron 4mg before emergence Analgesia: ropivacain at port sites before incision and at vaginal vault Opioids intravenously at discretion of anesthesiologist supplemented with Dexketoprofen 50mg Urinary catheter early removal Postoperative Pain: tramadol 50mg and ketoprofen100mg i.v., oral opioid if needed; patients with normal pain control receive oral pregabalin 25mg every 8 hours, paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours until discharge Out of bed after 2 hours from the end of surgery A liquid diet, if tolerated regular normal diet. For emesis ondansetron 4mg
Procedure: fast-track recovery program

Pre-operative: fast-track management counseling, fast-track educational video,tobacco cessation, daily physical activity, light meal 6 hours and clear liquids up to 2 hours before surgery, no bowel preparation, a warm blanket, medication.

Intra-operative: vaginal wound infiltrative anesthesia, early remove of urine catheter.

Post-operative: early oral intake liquids and food, early mobilization, avoiding opioids by use of pregabaline for postoperative pain.
No Intervention: conventional recovery program

Preoperative preparation Verbal and written information Cessation of oral intake after previous midnight. Premedication paracetamol 1g+ diatsepam 5mg.

Intraoperative A warm blanket at the start of procedure. Prophylaxis for nausea and vomiting: Dexamethasone 5mg at induction, and Dehydrobenzperidol 1mg, ondancetron 4mg before emergence. Analgesia: injection of ropivacain 5% 20ml at port sites at the end of surgery, Opioids i.v. (oxycodone)

Postoperative Pain medication:Opioids i.v. (oxycodone), paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours Urinary catheter removal on next morning. Prolonged bowel and bed rest and gradual reintroduction of feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospitalisation
Time Frame: up to one week
time from end of operation until discharge
up to one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain score
Time Frame: change in 24 hours after surgery
Visual analog score (VAS) for pain. The scale is from 0 to 10. 0 is no pain and 10 is worst imaginable pain.
change in 24 hours after surgery
nausea
Time Frame: change in 24 hours after surgery
Visual analog score (VAS) for nausea. the scale is from 0 to 10. 0 is no nausea and 10 is worst imaginable nausea.
change in 24 hours after surgery
vomiting
Time Frame: change in 24 hours after surgery
Visual analog score (VAS) for vomiting. The scale is from 0 to 10. 0 is no vomiting and 10 is worst imaginable vomiting´.
change in 24 hours after surgery
complications
Time Frame: Up to one week.
Frequency of complications.Values are given as n (%) and eventual complications are spesified.
Up to one week.
The use of anelgesics for posoperative pain.
Time Frame: change in 24 hours after surgery
Postoperative pain defined as total amount (mg) of analgesics used. Amount of use oxycodone (mg).
change in 24 hours after surgery
Patient quality of life
Time Frame: 1 month before the surgery, in the morning of surgery day and one month after surgery
Measurement quality of life by questionnaire 15D
1 month before the surgery, in the morning of surgery day and one month after surgery
Patient subjective psychological stress level by general health questionnaire(GHQ12)
Time Frame: 1 month before the surgery, in the morning of surgery day and one month after surgery
Measurement of psychological stress
1 month before the surgery, in the morning of surgery day and one month after surgery
patient quality of life
Time Frame: 1 month before the surgery, in the morning of surgery day and one month after surgery
Measurement quality of life by questionnaires WHOQO-BREF
1 month before the surgery, in the morning of surgery day and one month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Olga Kilpiö, MD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2016

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Unique Protocol ID: 98/13/03/0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share a data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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