A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy

Gynecologic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828981
• Other study ID #: Unique Protocol ID: 98/13/03/0
• Status: Completed
• Phase: N/A
• Start date: May 31, 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: February 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Surgery

Intervention

Procedure:
• fast-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.

Locations

Country	Name	City	State
Finland	Päivi Pakarinen	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (18)

Borendal Wodlin N, Nilsson L, Carlsson P, Kjølhede 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. — View 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. — View 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. — View Citation

Hansen CT, Sørensen M, Møller 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. — View Citation

Kjølhede 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. — View Citation

Kjølhede P, Langström 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. — View Citation

Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cárdenas-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. — View Citation

Møller 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. — View Citation

Nilsson L, Wodlin NB, Kjølhede 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wodlin NB, Nilsson L, Kjølhede P. [Fast track has its advantages in elective gynecological surgery]. Lakartidningen. 2014 Jun 17-Jul 1;111(25-26):1120-3. Review. Swedish. — View Citation

Wodlin NB, Nilsson L, Kjølhede 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. — View 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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospitalisation	time from end of operation until discharge	up to one week
Secondary	postoperative pain score	Visual analog score (VAS) for pain. The scale is from 0 to 10. 0 is no pain and 10 is worst imaginable pain.	change in 24 hours after surgery
Secondary	nausea	Visual analog score (VAS) for nausea. the scale is from 0 to 10. 0 is no nausea and 10 is worst imaginable nausea.	change in 24 hours after surgery
Secondary	vomiting	Visual analog score (VAS) for vomiting. The scale is from 0 to 10. 0 is no vomiting and 10 is worst imaginable vomiting´.	change in 24 hours after surgery
Secondary	complications	Frequency of complications.Values are given as n (%) and eventual complications are spesified.	Up to one week.
Secondary	The use of anelgesics for posoperative pain.	Postoperative pain defined as total amount (mg) of analgesics used. Amount of use oxycodone (mg).	change in 24 hours after surgery
Secondary	Patient quality of life	Measurement quality of life by questionnaire 15D	1 month before the surgery, in the morning of surgery day and one month after surgery
Secondary	Patient subjective psychological stress level by general health questionnaire(GHQ12)	Measurement of psychological stress	1 month before the surgery, in the morning of surgery day and one month after surgery
Secondary	patient quality of life	Measurement quality of life by questionnaires WHOQO-BREF	1 month before the surgery, in the morning of surgery day and one month after surgery