A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy

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

Detailed Description
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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.

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

Conditions
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Gynecologic Surgery

Intervention / Treatment
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* Procedure: fast-track recovery program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized superiority trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fast-track recovery program<br>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<br>* 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.<br>|
| No Intervention: conventional recovery program<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | 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 | 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 | 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 | Frequency of complications.Values are given as n (%) and eventual complications are spesified. | Up to one week. | 
| The use of anelgesics for posoperative pain. | 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 | 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) | Measurement of psychological stress | 1 month before the surgery, in the morning of surgery day and one month after surgery | 
| patient quality of life | Measurement quality of life by questionnaires WHOQO-BREF | 1 month before the surgery, in the morning of surgery day and one month after surgery |