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Completed

NCT Number: NCT03828981

A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy

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

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Key information

Conditions

Gynecologic Surgery

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Päivi Pakarinen

Helsinki, 00140, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fast-track recovery program

Procedure

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.

Primary outcomes

  1. length of hospitalisation

    Time frame: up to one week

    time from end of operation until discharge

Secondary outcomes

  1. postoperative pain score

    Time frame: 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.

  2. nausea

    Time frame: 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.

  3. vomiting

    Time frame: 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´.

  4. complications

    Time frame: Up to one week.

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

  5. The use of anelgesics for posoperative pain.

    Time frame: change in 24 hours after surgery

    Postoperative pain defined as total amount (mg) of analgesics used. Amount of use oxycodone (mg).

  6. Patient quality of life

    Time frame: 1 month before the surgery, in the morning of surgery day and one month after surgery

    Measurement quality of life by questionnaire 15D

  7. Patient subjective psychological stress level by general health questionnaire(GHQ12)

    Time frame: 1 month before the surgery, in the morning of surgery day and one month after surgery

    Measurement of psychological stress

  8. patient quality of life

    Time frame: 1 month before the surgery, in the morning of surgery day and one month after surgery

    Measurement quality of life by questionnaires WHOQO-BREF

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2019
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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