A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy
A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Helsinki, Finlande, 00140
- Päivi Pakarinen
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: fast-track recovery program
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 |
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. |
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Aucune intervention: conventional recovery program
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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length of hospitalisation
Délai: up to one week
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time from end of operation until discharge
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up to one week
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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postoperative pain score
Délai: change in 24 hours after surgery
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Visual analog score (VAS) for pain.
The scale is from 0 to 10. 0 is no pain and 10 is worst imaginable pain.
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change in 24 hours after surgery
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nausea
Délai: change in 24 hours after surgery
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Visual analog score (VAS) for nausea.
the scale is from 0 to 10. 0 is no nausea and 10 is worst imaginable nausea.
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change in 24 hours after surgery
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vomiting
Délai: change in 24 hours after surgery
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Visual analog score (VAS) for vomiting.
The scale is from 0 to 10. 0 is no vomiting and 10 is worst imaginable vomiting´.
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change in 24 hours after surgery
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complications
Délai: Up to one week.
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Frequency of complications.Values are given as n (%) and eventual complications are spesified.
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Up to one week.
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The use of anelgesics for posoperative pain.
Délai: change in 24 hours after surgery
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Postoperative pain defined as total amount (mg) of analgesics used.
Amount of use oxycodone (mg).
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change in 24 hours after surgery
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Patient quality of life
Délai: 1 month before the surgery, in the morning of surgery day and one month after surgery
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Measurement quality of life by questionnaire 15D
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1 month before the surgery, in the morning of surgery day and one month after surgery
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Patient subjective psychological stress level by general health questionnaire(GHQ12)
Délai: 1 month before the surgery, in the morning of surgery day and one month after surgery
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Measurement of psychological stress
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1 month before the surgery, in the morning of surgery day and one month after surgery
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patient quality of life
Délai: 1 month before the surgery, in the morning of surgery day and one month after surgery
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Measurement quality of life by questionnaires WHOQO-BREF
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1 month before the surgery, in the morning of surgery day and one month after surgery
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Olga Kilpiö, MD, Helsinki University Central Hospital
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
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Termes liés à cette étude
Autres numéros d'identification d'étude
- Unique Protocol ID: 98/13/03/0
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