Gynecologic Surgery
Conditions
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.
Interventions
PROCEDUREfast-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.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized superiority trial
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of hospitalisation | up to one week | time from end of operation until discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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´. |
| complications | Up to one week. | Frequency of complications.Values are given as n (%) and eventual complications are spesified. |
| 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. |
| 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 |
| 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 |
| 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). |
Countries
Finland
Outcome results
None listed