Clinical trial NCT03828981: A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy
Official title: A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Surgery
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized superiority trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: length of hospitalisation
timeFrame: up to one week
Secondary outcomes:
measure: postoperative pain score
timeFrame: change in 24 hours after surgery
measure: nausea
timeFrame: change in 24 hours after surgery
measure: vomiting
timeFrame: change in 24 hours after surgery
measure: complications
timeFrame: Up to one week.
measure: The use of anelgesics for posoperative pain.
timeFrame: change in 24 hours after surgery
measure: Patient quality of life
timeFrame: 1 month before the surgery, in the morning of surgery day and one month after surgery
measure: Patient subjective psychological stress level by general health questionnaire(GHQ12)
timeFrame: 1 month before the surgery, in the morning of surgery day and one month after surgery
measure: patient quality of life
timeFrame: 1 month before the surgery, in the morning of surgery day and one month after surgery
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Päivi Pakarinen
Study officials:
affiliation: Helsinki University Central Hospital
name: Olga Kilpiö, MD
role: STUDY_DIRECTOR
References:
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citation: Kilpio O, Harkki PSM, Mentula MJ, Pakarinen PI. Health-related Quality of Life after Laparoscopic Hysterectomy following Enhanced Recovery after Surgery Protocol or a Conventional Recovery Protocol. J Minim Invasive Gynecol. 2021 Sep;28(9):1650-1655. doi: 10.1016/j.jmig.2021.02.008. Epub 2021 Feb 11.
citation: Kilpio O, Harkki PSM, Mentula MJ, Vaananen A, Pakarinen PI. Recovery after enhanced versus conventional care laparoscopic hysterectomy performed in the afternoon: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Dec;151(3):392-398. doi: 10.1002/ijgo.13382. Epub 2020 Oct 19.