Fast-track Surgery After Gynecological Oncology Surgery
NCT ID: NCT02687412
Last Updated: 2019-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2016-11-21
2018-03-21
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fast-track Surgery
Pre-operative: Assessment, counseling and education; preoperative nutritional drink up to 4 h prior to surgery, bowel preparation, only oral intestinal cleaner，antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia keeping temperature at 36 ±0.5℃, antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery).
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).
Traditional surgery
pre-operative assessment：pre-operative fasting at least 8h, bowel preparation for traditional surgery, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.
Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 years or older
3. Signed informed consent provided
Exclusion Criteria
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
18 Years
70 Years
FEMALE
No
Sponsors
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Ling Cui
OTHER
Responsible Party
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Ling Cui
MD
Principal Investigators
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Ling Cui, MD
Role: STUDY_CHAIR
Sichuan Cancer Hospital and Research Institute
Yu Shi
Role: PRINCIPAL_INVESTIGATOR
Sichuan Cancer Hospital and Research Institute
Hong Liu
Role: PRINCIPAL_INVESTIGATOR
Sichuan Cancer Hospital and Research Institute
Dengfeng Wang
Role: PRINCIPAL_INVESTIGATOR
Sichuan Cancer Hospital and Research Institute
Locations
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LinShuangfeng
Leshan, Sichuan, China
Countries
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References
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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. No abstract available.
Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.
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. doi: 10.1159/000108327. Epub 2007 Sep 13.
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. No abstract available.
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. doi: 10.1016/s0140-6736(95)90643-6.
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.
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/wjg.v20.i46.17578.
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.
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 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
Kehlet H. Multimodal approach to postoperative recovery. Curr Opin Crit Care. 2009 Aug;15(4):355-8. doi: 10.1097/MCC.0b013e32832fbbe7.
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.
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.
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.
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. doi: 10.1016/s1074-3804(05)60239-3.
Lu D, Wang X, Shi G. Perioperative enhanced recovery programmes for gynaecological cancer patients. Cochrane Database Syst Rev. 2015 Mar 19;2015(3):CD008239. doi: 10.1002/14651858.CD008239.pub4.
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.
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. doi: 10.1080/00016340500408325.
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. doi: 10.7326/0003-4819-134-8-200104170-00011.
Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.
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.
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.
Sjetne IS, Krogstad U, Odegard 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.
Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
Cui L, Shi Y, Zhang GN. Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial. Trials. 2016 Dec 15;17(1):597. doi: 10.1186/s13063-016-1688-3.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SichuanCHRI
Identifier Type: -
Identifier Source: org_study_id
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