Fast-track Surgery After Gynecological Oncology Surgery

Postoperative Complications Clinical Trial

Official title:

Fast-track Surgery After Gynaecological Oncological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687412
• Other study ID #: SichuanCHRI
• Status: Completed
• Phase: N/A
• Start date: November 21, 2016
• Est. completion date: March 21, 2018

Study information

• Verified date: August 2019
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.

The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.

Description:

Methods/Design

Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis and APACHE II score.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 21, 2018
• Est. primary completion date: September 2, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)

2. Aged 18 years or older

3. Signed informed consent provided

Exclusion Criteria:

1. Patients with a documented infection at the time of operation

2. Aged 71 years or older

3. Patients with ileus at the time of operation

4. Patients with hypocoagulability

5. Patients with psychosis, Alcohol dependence or drug abuse history

6. Patients with primary nephrotic or hepatic disease

7. Patients with severe hypertension systolic pressure=160mmHg, diastolic pressure>90mmHg

Related Conditions & MeSH terms

• CRP
• Length of Stay
• Postoperative Complications

Intervention

Procedure:
• pre-operative assessment, counseling and education
pre-operative assessment, counseling and FT management education
• Preoperative nutritional drink up to 4 h prior to surgery
Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used
• bowel preparation
patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool
• preoperative treatment with carbohydrates
preoperative treatment with carbohydrates (patients without diabetes).
• fast solid
fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;
• avoiding hypothermia
avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.
• Postoperative glycaemic control
Postoperative glycaemic control;
• postoperative nausea and vomiting (PONV) control;

• early postoperative diet
early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).
• pre-operative fasting at least 8h

• bowel preparation for traditional surgery
Oral bowel preparations or mechanical bowl until liquid stool
• began to take solid diet after anal exhaust
6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

Locations

Country	Name	City	State
China	LinShuangfeng	Leshan	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Ling Cui

Country where clinical trial is conducted

China, 

References & Publications (22)

Acheson N, Crawford R. The impact of mode of anaesthesia on postoperative recovery from fast-track abdominal hysterectomy: a randomised clinical trial. BJOG. 2011 Feb;118(3):271-3. doi: 10.1111/j.1471-0528.2010.02811.x. — View Citation

Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. — View Citation

Bona S, Molteni M, Rosati R, Elmore U, Bagnoli P, Monzani R, Caravaca M, Montorsi M. Introducing an enhanced recovery after surgery program in colorectal surgery: a single center experience. World J Gastroenterol. 2014 Dec 14;20(46):17578-87. doi: 10.3748 — View Citation

Carter J, Szabo R, Sim WW, Pather S, Philp S, Nattress K, Cotterell S, Patel P, Dalrymple C. Fast track surgery: a clinical audit. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):159-63. doi: 10.1111/j.1479-828X.2009.01134.x. — View Citation

Carter J. Fast-track surgery in gynaecology and gynaecologic oncology: a review of a rolling clinical audit. ISRN Surg. 2012;2012:368014. doi: 10.5402/2012/368014. Epub 2012 Dec 24. — View Citation

Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Ju — View Citation

Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a. Review. — View Citation

Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. Review. — View Citation

Kehlet H. Fast-track colorectal surgery. Lancet. 2008 Mar 8;371(9615):791-3. doi: 10.1016/S0140-6736(08)60357-8. Review. — View Citation

Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6. Review. — View Citation

Kehlet H. Multimodal approach to postoperative recovery. Curr Opin Crit Care. 2009 Aug;15(4):355-8. doi: 10.1097/MCC.0b013e32832fbbe7. Review. — View Citation

Kranke P, Redel A, Schuster F, Muellenbach R, Eberhart LH. Pharmacological interventions and concepts of fast-track perioperative medical care for enhanced recovery programs. Expert Opin Pharmacother. 2008 Jun;9(9):1541-64. doi: 10.1517/14656566.9.9.1541 — View Citation

Lin YS. Preliminary results of laparoscopic modified radical hysterectomy in early invasive cervical cancer. J Am Assoc Gynecol Laparosc. 2003 Feb;10(1):80-4. — View Citation

Lu D, Wang X, Shi G. Perioperative enhanced recovery programmes for gynaecological cancer patients. Cochrane Database Syst Rev. 2015 Mar 19;(3):CD008239. doi: 10.1002/14651858.CD008239.pub4. Review. — View Citation

Lv D, Wang X, Shi G. Perioperative enhanced recovery programmes for gynaecological cancer patients. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD008239. doi: 10.1002/14651858.CD008239.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;12:CD008239. — View Citation

Marx C, Rasmussen T, Jakobsen DH, Ottosen C, Lundvall L, Ottesen B, Callesen T, Kehlet H. The effect of accelerated rehabilitation on recovery after surgery for ovarian malignancy. Acta Obstet Gynecol Scand. 2006;85(4):488-92. — View Citation

Moher D, Schulz KF, Altman DG; CONSORT GROUP (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001 Apr 17;134(8):657-62. — View Citation

Mortensen K, Nilsson M, Slim K, Schäfer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS®) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS — View Citation

Philp S, Carter J, Pather S, Barnett C, D'Abrew N, White K. Patients' satisfaction with fast-track surgery in gynaecological oncology. Eur J Cancer Care (Engl). 2015 Jul;24(4):567-73. doi: 10.1111/ecc.12254. Epub 2014 Oct 21. — View Citation

Polle SW, Wind J, Fuhring JW, Hofland J, Gouma DJ, Bemelman WA. Implementation of a fast-track perioperative care program: what are the difficulties? Dig Surg. 2007;24(6):441-9. Epub 2007 Sep 13. — View Citation

Pruthi RS, Nielsen M, Smith A, Nix J, Schultz H, Wallen EM. Fast track program in patients undergoing radical cystectomy: results in 362 consecutive patients. J Am Coll Surg. 2010 Jan;210(1):93-9. doi: 10.1016/j.jamcollsurg.2009.09.026. Epub 2009 Oct 28. — View Citation

Sjetne IS, Krogstad U, Ødegård S, Engh ME. Improving quality by introducing enhanced recovery after surgery in a gynaecological department: consequences for ward nursing practice. Qual Saf Health Care. 2009 Jun;18(3):236-40. doi: 10.1136/qshc.2007.023382. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospitalization Post-operation	days from operation date to discharge date	up to 12 months
Primary	The Total Cost (RMB)	The total cost from hospitalization	12 month
Secondary	CRP	C-Reactive protein mg/L	up to 12 months
Secondary	Number of Participants With Complications	Count of patients with complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis.	up to 12 months
Secondary	Number of Participants With Infection,	infection(wound infection, lung infection, intraperitoneal infection, operation space infection)	up to 12 months
Secondary	Number of Participants With Postoperative Nausea and Vomiting (PONV)	it was recognized that nausea and vomiting are common side effects of surgical recovery	up to 12 months
Secondary	Number of Participants With Ileus	is a disruption of the normal propulsive ability of the gastrointestinal tract	up to 12 months
Secondary	Number of Participants With Postoperative Haemorrhage	Evidence of blood loss from drains or based on ultrasonography	up to 12 months
Secondary	Number of Participants With Postoperative Thrombosis	Evidence of blood thrombosis of participants after surgery	up to 12 months
Secondary	PCT Calcitonin Postoperative	value of calcitonin postoperative	12 month
Secondary	Cost of Surgical Therapy	Cost of surgical therapy (RMB)	12 month