A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy

Not Applicable

Completed

• Conditions: Gynecologic Surgery
• Interventions: Procedure: fast-track recovery program

• Registration Number: NCT03828981
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-05-31
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Study First Submitted: 2019-01-21
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fast-track recovery program	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

Primary Outcome Measures

Name	Time	Method
length of hospitalisation	up to one week	time from end of operation until discharge

Secondary Outcome Measures

Name	Time	Method
postoperative pain score	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.
nausea	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.
vomiting	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´.
Patient subjective psychological stress level by general health questionnaire(GHQ12)	1 month before the surgery, in the morning of surgery day and one month after surgery	Measurement of psychological stress
patient quality of life	1 month before the surgery, in the morning of surgery day and one month after surgery	Measurement quality of life by questionnaires WHOQO-BREF
complications	Up to one week.	Frequency of complications.Values are given as n (%) and eventual complications are spesified.
The use of anelgesics for posoperative pain.	change in 24 hours after surgery	Postoperative pain defined as total amount (mg) of analgesics used. Amount of use oxycodone (mg).
Patient quality of life	1 month before the surgery, in the morning of surgery day and one month after surgery	Measurement quality of life by questionnaire 15D

Trial Locations

Locations (1)

Päivi Pakarinen; 🇫🇮 Helsinki, Finland