Postoperative Complications Clinical Trial
Official title:
Fast-track Surgery After Gynaecological Oncological Surgery
Verified date | August 2019 |
Source | Sichuan Cancer Hospital and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | LinShuangfeng | Leshan | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Ling Cui |
China,
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
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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
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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
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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
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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
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* Note: There are 22 references in all — Click here to view all references
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 |
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