A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy

Helsinki University Central Hospital120 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Gynecologic Surgery

Interventions

fast-track recovery programPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Päivi Pakarinen

Helsinki, Finland

Outcomes

Primary Outcomes

length of hospitalisation

time from end of operation until discharge

Time frame: up to one week

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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´.

Time frame: change in 24 hours after surgery

complications

Frequency of complications.Values are given as n (%) and eventual complications are spesified.

Time frame: 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).

Time frame: change in 24 hours after surgery

Patient quality of life

Measurement quality of life by questionnaire 15D

Time frame: 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)

Data from ClinicalTrials.gov

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