Fast-track Surgery After Gynecological Oncology Surgery

NCT02687412 | Completed Results

• 1 other identifier: SichuanCHRI
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Length of Stay; Postoperative Complications; CRP

Keywords

Fast-track surgery; Gynecological oncology; Hospitalization post-operation; Complication

Outcome Measures

Primary Outcomes (2)

• Length of Hospitalization Post-operation

  days from operation date to discharge date

  up to 12 months

• The Total Cost (RMB)

  The total cost from hospitalization

  12 month

Secondary Outcomes (9)

• CRP

  up to 12 months

• Number of Participants With Complications

  up to 12 months

• Number of Participants With Infection,

  up to 12 months

• Number of Participants With Postoperative Nausea and Vomiting (PONV)

  up to 12 months

• Number of Participants With Ileus

  up to 12 months

Study Arms (2)

Fast-track Surgery

EXPERIMENTAL

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).

Procedure: pre-operative assessment, counseling and education; Procedure: Preoperative nutritional drink up to 4 h prior to surgery; Procedure: bowel preparation; Procedure: preoperative treatment with carbohydrates; Procedure: fast solid; Procedure: avoiding hypothermia; Procedure: Postoperative glycaemic control; Procedure: postoperative nausea and vomiting (PONV) control;; Procedure: early postoperative diet

Traditional surgery

OTHER

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

Procedure: pre-operative fasting at least 8h; Procedure: bowel preparation for traditional surgery; Procedure: began to take solid diet after anal exhaust

Interventions

pre-operative assessment, counseling and education PROCEDURE

pre-operative assessment, counseling and FT management education

Fast-track Surgery

Preoperative nutritional drink up to 4 h prior to surgery PROCEDURE

Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used

Fast-track Surgery

bowel preparation PROCEDURE

patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool

Fast-track Surgery

preoperative treatment with carbohydrates PROCEDURE

preoperative treatment with carbohydrates (patients without diabetes).

Fast-track Surgery

fast solid PROCEDURE

fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;

Fast-track Surgery

avoiding hypothermia PROCEDURE

avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.

Fast-track Surgery

Postoperative glycaemic control PROCEDURE

Postoperative glycaemic control;

Fast-track Surgery

postoperative nausea and vomiting (PONV) control; PROCEDURE

Fast-track Surgery

early postoperative diet PROCEDURE

early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).

Fast-track Surgery

pre-operative fasting at least 8h PROCEDURE

Traditional surgery

bowel preparation for traditional surgery PROCEDURE

Oral bowel preparations or mechanical bowl until liquid stool

Traditional surgery

began to take solid diet after anal exhaust PROCEDURE

6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

Traditional surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
• Aged 18 years or older
• Signed informed consent provided

You may not qualify if:

• Patients with a documented infection at the time of operation
• Aged 71 years or older
• Patients with ileus at the time of operation
• Patients with hypocoagulability
• Patients with psychosis, Alcohol dependence or drug abuse history
• Patients with primary nephrotic or hepatic disease
• Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure\>90mmHg

Sponsors & Collaborators

• Ling Cui: lead

Study Sites (1)

LinShuangfeng

Leshan, Sichuan, 610000, China

Location

Related Publications (24)

• 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.

  PMID: 18328911 BACKGROUND

• 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.

  PMID: 12095591 BACKGROUND

• 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.

  PMID: 17851238 BACKGROUND

• 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.

  PMID: 21226823 RESULT

• 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.

  PMID: 7891489 RESULT

• 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.

  PMID: 20522073 RESULT

• 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.

  PMID: 25516673 RESULT

• 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.

  PMID: 23320193 RESULT

• 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.

  PMID: 15896435 RESULT

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

  PMID: 19617822 RESULT

• 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.

  PMID: 21468643 RESULT

• 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.

  PMID: 18650627 RESULT

• 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.

  PMID: 18518784 RESULT

• 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.

  PMID: 12554999 RESULT

• 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.

  PMID: 25789452 RESULT

• 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.

  PMID: 20556792 RESULT

• 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.

  PMID: 16612713 RESULT

• 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.

  PMID: 11304106 RESULT

• 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.

  PMID: 25047143 RESULT

• 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.

  PMID: 25335828 RESULT

• 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.

  PMID: 20123338 RESULT

• 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.

  PMID: 19468009 RESULT

• 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.

  PMID: 35289396 DERIVED

• 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.

  PMID: 27978842 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Counseling; Educational Status; Cathartics; Carbohydrates

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr Cui Ling
• Organization: SichuanCHRI

cuiling1985@qq.com

+8618181422637

Study Officials

• Ling Cui, MD

  Sichuan Cancer Hospital and Research Institute

  STUDY CHAIR

• Yu Shi

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

• Hong Liu

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

• Dengfeng Wang

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were randomly divided into two groups（ FTS group/traditional group）, after that doctors and patients were aware of the grouping situation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: prospective randomised controlled trial

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 22, 2016
• Study Start: November 21, 2016
• Primary Completion: September 2, 2017
• Study Completion: March 21, 2018
• Last Updated: September 26, 2019
• Results First Posted: September 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)