<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03828981</url>
  </required_header>
  <id_info>
    <org_study_id>Unique Protocol ID: 98/13/03/0</org_study_id>
    <nct_id>NCT03828981</nct_id>
  </id_info>
  <brief_title>A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy</brief_title>
  <official_title>A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Factors affecting to length of hospital stay after fast-track recovery program in&#xD;
      laparoscopic hysterectomy compared to conventional recovery program&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Factors affecting to length of hospital stay after laparoscopic hysterectomy in fast-track&#xD;
      recovery program group compared to conventional recovery group.&#xD;
&#xD;
      The pimary outcome is time to discharge from the end of operation to discharge.&#xD;
&#xD;
      The second outcomes are amount of opioid used and NSAID, postoperative paine, nousea and&#xD;
      vomiting, patients satisfaction, anxiety and stress-coping test, operative bleeding,&#xD;
      operative time, postoperative complications, the cost of the laparoscopic hysterectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2016</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized superiority trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of hospitalisation</measure>
    <time_frame>up to one week</time_frame>
    <description>time from end of operation until discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain score</measure>
    <time_frame>change in 24 hours after surgery</time_frame>
    <description>Visual analog score (VAS) for pain. The scale is from 0 to 10. 0 is no pain and 10 is worst imaginable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nausea</measure>
    <time_frame>change in 24 hours after surgery</time_frame>
    <description>Visual analog score (VAS) for nausea. the scale is from 0 to 10. 0 is no nausea and 10 is worst imaginable nausea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vomiting</measure>
    <time_frame>change in 24 hours after surgery</time_frame>
    <description>Visual analog score (VAS) for vomiting. The scale is from 0 to 10. 0 is no vomiting and 10 is worst imaginable vomiting´.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>Up to one week.</time_frame>
    <description>Frequency of complications.Values are given as n (%) and eventual complications are spesified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The use of anelgesics for posoperative pain.</measure>
    <time_frame>change in 24 hours after surgery</time_frame>
    <description>Postoperative pain defined as total amount (mg) of analgesics used. Amount of use oxycodone (mg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient quality of life</measure>
    <time_frame>1 month before the surgery, in the morning of surgery day and one month after surgery</time_frame>
    <description>Measurement quality of life by questionnaire 15D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient subjective psychological stress level by general health questionnaire(GHQ12)</measure>
    <time_frame>1 month before the surgery, in the morning of surgery day and one month after surgery</time_frame>
    <description>Measurement of psychological stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient quality of life</measure>
    <time_frame>1 month before the surgery, in the morning of surgery day and one month after surgery</time_frame>
    <description>Measurement quality of life by questionnaires WHOQO-BREF</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Gynecologic Surgery</condition>
  <arm_group>
    <arm_group_label>fast-track recovery program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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&#xD;
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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional recovery program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Preoperative preparation Verbal and written information Cessation of oral intake after previous midnight. Premedication paracetamol 1g+ diatsepam 5mg.&#xD;
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)&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fast-track recovery program</intervention_name>
    <description>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.&#xD;
Intra-operative: vaginal wound infiltrative anesthesia, early remove of urine catheter.&#xD;
Post-operative: early oral intake liquids and food, early mobilization, avoiding opioids by use of pregabaline for postoperative pain.</description>
    <arm_group_label>fast-track recovery program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  uterine size less than uterine size at 14 weeks of pregnancy&#xD;
&#xD;
          -  at list one friend or family available to care to care after discharge.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  endometriosis&#xD;
&#xD;
          -  contraindications to any of medications used in the study (oxycodone, ketoprofen, or&#xD;
             paracetamol)&#xD;
&#xD;
          -  language difficulties (inability to understand and speak Finnish or Swedish)&#xD;
&#xD;
          -  age older that 70 years&#xD;
&#xD;
          -  mental health disability that limit autonomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Kilpiö, MD</last_name>
    <role>Study Director</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Päivi Pakarinen</name>
      <address>
        <city>Helsinki</city>
        <zip>00140</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <reference>
    <citation>Borendal Wodlin N, Nilsson L, Carlsson P, Kjolhede P. Cost-effectiveness of general anesthesia vs spinal anesthesia in fast-track abdominal benign hysterectomy. Am J Obstet Gynecol. 2011 Oct;205(4):326.e1-7. doi: 10.1016/j.ajog.2011.05.043. Epub 2011 Jun 7.</citation>
    <PMID>22083055</PMID>
  </reference>
  <reference>
    <citation>Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9. Erratum In: BJOG. 2012 Sep;119(10):1291.</citation>
    <PMID>22568450</PMID>
  </reference>
  <reference>
    <citation>Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.</citation>
    <PMID>22893770</PMID>
  </reference>
  <reference>
    <citation>Nilsson L, Wodlin NB, Kjolhede P. Risk factors for postoperative complications after fast-track abdominal hysterectomy. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):113-20. doi: 10.1111/j.1479-828X.2011.01395.x. Epub 2012 Jan 8.</citation>
    <PMID>22224504</PMID>
  </reference>
  <reference>
    <citation>Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta Obstet Gynecol Scand. 2013 Jan;92(1):17-27. doi: 10.1111/j.1600-0412.2012.01525.x. Epub 2012 Nov 1.</citation>
    <PMID>22880948</PMID>
  </reference>
  <reference>
    <citation>Wodlin NB, Nilsson L, Kjolhede P. [Fast track has its advantages in elective gynecological surgery]. Lakartidningen. 2014 Jun 17-Jul 1;111(25-26):1120-3. No abstract available. Swedish.</citation>
    <PMID>25072075</PMID>
  </reference>
  <reference>
    <citation>Wodlin NB, Nilsson L, Kjolhede P. Health-related quality of life and postoperative recovery in fast-track hysterectomy. Acta Obstet Gynecol Scand. 2011 Apr;90(4):362-8. doi: 10.1111/j.1600-0412.2010.01058.x. Epub 2011 Feb 18.</citation>
    <PMID>21306322</PMID>
  </reference>
  <reference>
    <citation>Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.</citation>
    <PMID>22241289</PMID>
  </reference>
  <reference>
    <citation>Wijk L, Franzen K, Ljungqvist O, Nilsson K. Implementing a structured Enhanced Recovery After Surgery (ERAS) protocol reduces length of stay after abdominal hysterectomy. Acta Obstet Gynecol Scand. 2014 Aug;93(8):749-56. doi: 10.1111/aogs.12423. Epub 2014 Jun 13.</citation>
    <PMID>24828471</PMID>
  </reference>
  <reference>
    <citation>van Bree SH, Vlug MS, Bemelman WA, Hollmann MW, Ubbink DT, Zwinderman AH, de Jonge WJ, Snoek SA, Bolhuis K, van der Zanden E, The FO, Bennink RJ, Boeckxstaens GE. Faster recovery of gastrointestinal transit after laparoscopy and fast-track care in patients undergoing colonic surgery. Gastroenterology. 2011 Sep;141(3):872-880.e1-4. doi: 10.1053/j.gastro.2011.05.034. Epub 2011 May 26. Erratum In: Gastroenterology. 2012 Mar;142(3):676. multiple author names corrected.</citation>
    <PMID>21699777</PMID>
  </reference>
  <reference>
    <citation>Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.</citation>
    <PMID>21597360</PMID>
  </reference>
  <reference>
    <citation>Relph S, Bell A, Sivashanmugarajan V, Munro K, Chigwidden K, Lloyd S, Fakokunde A, Yoong W. Cost effectiveness of enhanced recovery after surgery programme for vaginal hysterectomy: a comparison of pre and post-implementation expenditures. Int J Health Plann Manage. 2014 Oct-Dec;29(4):399-406. doi: 10.1002/hpm.2182. Epub 2013 May 10.</citation>
    <PMID>23661616</PMID>
  </reference>
  <reference>
    <citation>Rhou YJ, Pather S, Loadsman JA, Campbell N, Philp S, Carter J. Direct hospital costs of total laparoscopic hysterectomy compared with fast-track open hysterectomy at a tertiary hospital: a retrospective case-controlled study. Aust N Z J Obstet Gynaecol. 2015 Dec;55(6):584-7. doi: 10.1111/ajo.12093. Epub 2013 May 2.</citation>
    <PMID>23634987</PMID>
  </reference>
  <reference>
    <citation>Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cardenas-Rebollo JM, Biffi R. Clinical outcomes after fast-track care in women undergoing laparoscopic hysterectomy. Int J Gynaecol Obstet. 2015 Dec;131(3):301-4. doi: 10.1016/j.ijgo.2015.06.034. Epub 2015 Sep 8.</citation>
    <PMID>26386495</PMID>
  </reference>
  <reference>
    <citation>Feroci F, Lenzi E, Baraghini M, Garzi A, Vannucchi A, Cantafio S, Scatizzi M. Fast-track surgery in real life: how patient factors influence outcomes and compliance with an enhanced recovery clinical pathway after colorectal surgery. Surg Laparosc Endosc Percutan Tech. 2013 Jun;23(3):259-65. doi: 10.1097/SLE.0b013e31828ba16f.</citation>
    <PMID>23751989</PMID>
  </reference>
  <reference>
    <citation>Gouvas N, Tan E, Windsor A, Xynos E, Tekkis PP. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009 Oct;24(10):1119-31. doi: 10.1007/s00384-009-0703-5. Epub 2009 May 5.</citation>
    <PMID>19415308</PMID>
  </reference>
  <reference>
    <citation>Hansen CT, Sorensen M, Moller C, Ottesen B, Kehlet H. Effect of laxatives on gastrointestinal functional recovery in fast-track hysterectomy: a double-blind, placebo-controlled randomized study. Am J Obstet Gynecol. 2007 Apr;196(4):311.e1-7. doi: 10.1016/j.ajog.2006.10.902.</citation>
    <PMID>17403400</PMID>
  </reference>
  <reference>
    <citation>Moller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):18-22. doi: 10.1016/s0301-2115(01)00342-6.</citation>
    <PMID>11516794</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Päivi Päkarinen</investigator_full_name>
    <investigator_title>MD PhD Specialist on gynecologic oncology,senior consultant, gynecologic onkology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan to share a data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828981
org study id: Unique Protocol ID: 98/13/03/0
nct id: NCT03828981
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized superiority trial
primary purpose: Treatment
masking: None (Open Label)
measure: length of hospitalisation
time frame: up to one week
description: time from end of operation until discharge
measure: postoperative pain score
time frame: change in 24 hours after surgery
description: Visual analog score (VAS) for pain. The scale is from 0 to 10. 0 is no pain and 10 is worst imaginable pain.
measure: nausea
time frame: change in 24 hours after surgery
description: Visual analog score (VAS) for nausea. the scale is from 0 to 10. 0 is no nausea and 10 is worst imaginable nausea.
measure: vomiting
time frame: change in 24 hours after surgery
description: Visual analog score (VAS) for vomiting. The scale is from 0 to 10. 0 is no vomiting and 10 is worst imaginable vomiting´.
measure: complications
time frame: Up to one week.
description: Frequency of complications.Values are given as n (%) and eventual complications are spesified.
measure: The use of anelgesics for posoperative pain.
time frame: change in 24 hours after surgery
description: Postoperative pain defined as total amount (mg) of analgesics used. Amount of use oxycodone (mg).
measure: Patient quality of life
time frame: 1 month before the surgery, in the morning of surgery day and one month after surgery
description: Measurement quality of life by questionnaire 15D
measure: 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
description: Measurement of psychological stress
measure: patient quality of life
time frame: 1 month before the surgery, in the morning of surgery day and one month after surgery
description: Measurement quality of life by questionnaires WHOQO-BREF
arm group label: fast-track recovery program
arm group type: Active Comparator
description: 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
arm group label: conventional recovery program
arm group type: No Intervention
description: 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.
intervention type: Procedure
intervention name: fast-track recovery program
description: 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.
arm group label: fast-track recovery program
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olga Kilpiö, MD
role: Study Director
affiliation: Helsinki University Central Hospital
facility: 
country: Finland
citation: Borendal Wodlin N, Nilsson L, Carlsson P, Kjolhede P. Cost-effectiveness of general anesthesia vs spinal anesthesia in fast-track abdominal benign hysterectomy. Am J Obstet Gynecol. 2011 Oct;205(4):326.e1-7. doi: 10.1016/j.ajog.2011.05.043. Epub 2011 Jun 7.
PMID: 22083055
citation: Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9. Erratum In: BJOG. 2012 Sep;119(10):1291.
PMID: 22568450
citation: Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
PMID: 22893770
citation: Nilsson L, Wodlin NB, Kjolhede P. Risk factors for postoperative complications after fast-track abdominal hysterectomy. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):113-20. doi: 10.1111/j.1479-828X.2011.01395.x. Epub 2012 Jan 8.
PMID: 22224504
citation: Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta Obstet Gynecol Scand. 2013 Jan;92(1):17-27. doi: 10.1111/j.1600-0412.2012.01525.x. Epub 2012 Nov 1.
PMID: 22880948
citation: Wodlin NB, Nilsson L, Kjolhede P. [Fast track has its advantages in elective gynecological surgery]. Lakartidningen. 2014 Jun 17-Jul 1;111(25-26):1120-3. No abstract available. Swedish.
PMID: 25072075
citation: Wodlin NB, Nilsson L, Kjolhede P. Health-related quality of life and postoperative recovery in fast-track hysterectomy. Acta Obstet Gynecol Scand. 2011 Apr;90(4):362-8. doi: 10.1111/j.1600-0412.2010.01058.x. Epub 2011 Feb 18.
PMID: 21306322
citation: Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.
PMID: 22241289
citation: Wijk L, Franzen K, Ljungqvist O, Nilsson K. Implementing a structured Enhanced Recovery After Surgery (ERAS) protocol reduces length of stay after abdominal hysterectomy. Acta Obstet Gynecol Scand. 2014 Aug;93(8):749-56. doi: 10.1111/aogs.12423. Epub 2014 Jun 13.
PMID: 24828471
citation: van Bree SH, Vlug MS, Bemelman WA, Hollmann MW, Ubbink DT, Zwinderman AH, de Jonge WJ, Snoek SA, Bolhuis K, van der Zanden E, The FO, Bennink RJ, Boeckxstaens GE. Faster recovery of gastrointestinal transit after laparoscopy and fast-track care in patients undergoing colonic surgery. Gastroenterology. 2011 Sep;141(3):872-880.e1-4. doi: 10.1053/j.gastro.2011.05.034. Epub 2011 May 26. Erratum In: Gastroenterology. 2012 Mar;142(3):676. multiple author names corrected.
PMID: 21699777
citation: Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.
PMID: 21597360
citation: Relph S, Bell A, Sivashanmugarajan V, Munro K, Chigwidden K, Lloyd S, Fakokunde A, Yoong W. Cost effectiveness of enhanced recovery after surgery programme for vaginal hysterectomy: a comparison of pre and post-implementation expenditures. Int J Health Plann Manage. 2014 Oct-Dec;29(4):399-406. doi: 10.1002/hpm.2182. Epub 2013 May 10.
PMID: 23661616
citation: Rhou YJ, Pather S, Loadsman JA, Campbell N, Philp S, Carter J. Direct hospital costs of total laparoscopic hysterectomy compared with fast-track open hysterectomy at a tertiary hospital: a retrospective case-controlled study. Aust N Z J Obstet Gynaecol. 2015 Dec;55(6):584-7. doi: 10.1111/ajo.12093. Epub 2013 May 2.
PMID: 23634987
citation: Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cardenas-Rebollo JM, Biffi R. Clinical outcomes after fast-track care in women undergoing laparoscopic hysterectomy. Int J Gynaecol Obstet. 2015 Dec;131(3):301-4. doi: 10.1016/j.ijgo.2015.06.034. Epub 2015 Sep 8.
PMID: 26386495
citation: Feroci F, Lenzi E, Baraghini M, Garzi A, Vannucchi A, Cantafio S, Scatizzi M. Fast-track surgery in real life: how patient factors influence outcomes and compliance with an enhanced recovery clinical pathway after colorectal surgery. Surg Laparosc Endosc Percutan Tech. 2013 Jun;23(3):259-65. doi: 10.1097/SLE.0b013e31828ba16f.
PMID: 23751989
citation: Gouvas N, Tan E, Windsor A, Xynos E, Tekkis PP. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009 Oct;24(10):1119-31. doi: 10.1007/s00384-009-0703-5. Epub 2009 May 5.
PMID: 19415308
citation: Hansen CT, Sorensen M, Moller C, Ottesen B, Kehlet H. Effect of laxatives on gastrointestinal functional recovery in fast-track hysterectomy: a double-blind, placebo-controlled randomized study. Am J Obstet Gynecol. 2007 Apr;196(4):311.e1-7. doi: 10.1016/j.ajog.2006.10.902.
PMID: 17403400
citation: Moller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):18-22. doi: 10.1016/s0301-2115(01)00342-6.
PMID: 11516794
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Päivi Päkarinen
investigator title: MD PhD Specialist on gynecologic oncology,senior consultant, gynecologic onkology
sharing ipd: No
ipd description: no plan to share a data