Fast-track Surgery After Gynaecological Oncological Surgery
Phase: NA
Conditions: Length of Stay, Postoperative Complications, CRP
Sponsor: Ling Cui

Title：
Fast-track Surgery After Gynecological 
Oncology Surgery 
NCT number：NCT02687412 
Date of the document：January 18, 2017 

Fast-track surgery after gynecological oncology 
surgery: study protocol for a randomized 
controlled trial 
Ling. Cui , Yu. Shi, Guonan Zhang. Department of Gynecological Oncology, Second 
People’s Hospital of Sichuan, Sichuan Cancer Hospital, Chengdu 610041, Sichuan, 
People’s Republic of China. 
Ling. Cui e-mail:306127582@qq.com 
Yu. Shi e-mail: docshiyu@163.com 
Guonan Zhang e-mail: zhanggn@hotmail.com 
 
Abstract 
Background 
Fast-track surgery (FTS) pathway, also knownas enhanced recovery after surgery 
(ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce 
complications, minimise hospital stay without an increased readmissionrate and 
reduce healthcare costs, all without compromising patient safety. The FTS pathway 
have been a dopted by most surgical specialties worldwide, and it has been used 
successfully in non-malignant gynecological surgery, but it has been proven to be 
especially effective in elective colorectal surgery. 
 
The advantages of fast-track principles that have been documented in connection with 
abdominal surgery most likely extend to the field of gynecology, but this is only an 
assumption, since fast-track in elective gynecological surgery has not been studied 
carefully so far. 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. 
 
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. 
 
Discussion 
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. 
 
Background 
Fast-track surgery (FTS) pathway, also knownas enhanced recovery after surgery 
(ERAS), was initiated in1995 by Bardram et al[1]. FTS is a multidisciplinary 
approach aiming to accelerate recovery, reduce complications, minimisehospital stay 
without an increased readmissionrate and reduce healthcare costs, all without 
compromising patient safety[2].The FTS pathway have been a dopted by most 
surgical specialties worldwide, and it has been used successfully in non-malignant 
gynecological surgery[3, 4], but it has been proven to be especially effective in 
elective colorectal surgery[5-7]. 
 
The speed of postoperative recovery is influenced by multiple factors such as 
occurrence of pain, postoperative nausea and vomiting (PONV), paralytic ileus, 
fatigue and sleep disturbances. A multimodal approach to prevent and minimize 
these factors is considered to be essential in order to enhance recovery[2, 5, 6, 8]. 
Fast-track principles include a series of elements such as providing the patient with 
thorough preoperative information and education concerning pre-, per- and 
postoperative care, the use of safe and short-acting anesthetics and optimal dynamic 
pain relief with minimal use of opioids, management of PONV, enteral nutrition and 
early mobilization,and use of minimal invasive surgery [9]. 
 
The advantages of fast-track principles that have been documented in connection with 
abdominal surgery most likely extend to the field of gynecology, but this is only an 
assumption, since fast-track in elective gynecological surgery has not been studied 
carefully so far. There is a existing research showed FTS in gynecological oncology 
provide early hospital discharge after gynaecological surgery meanwhile with high 
levels of patient satisfaction[10]. 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[3, 11, 12]. 
 
In contemporary surgical care patients would often be admitted to hospital the day prior 
to planned surgery, undergo preoperative mechanical and antibiotic bowel preparation 
and have IV fluids running to keep them in fluid balance, prior to any surgical or 
anaesthetic insult. Intraoperatively patients were often volume loaded to maintain a 
filling pressure, as well as pelvic drains to prevent development of collections, then 
spent 2 - 3 days nil by mouth (NBM) until bowel sounds were heard before being 
commenced on a graduated diet of clear liquids, free fluids, light diet and finally 
commenced on a regular diet 5 - 7 days post surgery. Patients were then discharged, on 
average 5 - 7 days post surgery[13]. Fast Track Surgery (FTS) or Enhanced Surgical 
Recovery (ESR) programs have been developed and refined in many specialties with 
documented improved patient outcomes and as a consequence earlier discharge form 
hospital and reduced length of stay (LOS)[2, 14, 15].  
 
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.  
 
Methods/Design 
Objectives and hypothesis 
Comparison of Fast-Track (FT) and traditional management protocols. 
The following hypotheses will be tested: 
H0: The recoveryand postoperative complications is equal in both groups. 
H1: The recoverywas enhanced and postoperative complications is different in 
bothgroups. 
 
Study population and eligibility criteria 
The trial is designed as a randomized, controlled, nonblinded and single-centertrial. 
The centre: Department of gynecological oncologyof Si Chuan Cancer Hospital 
Chengdu, Sichuan, China 
Detailed inclusion and exclusion criteria are described below. 
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.  
 
 
 
Sample size calculation 
The sample size calculation is based on the Length of hospitalization post-operation. 
The standard deviation of length of hospitalization post-operation in the traditional 
group is1.5 based on previous studies[16, 17]. 
 
We estimated the number of patients needed in a superiority trial with an effect size of 
90 % and a margin of 10 (alpha 5 %, power 90 %). where uα =1.96 and uβ =1.28 
and using the equation n = [2(uα+uβ)σ /δ]2, a sample size of 47 patients per 
group is necessary to detect a difference between the groups. With an expected 
dropout rate of 20%, we plan to enrol 120 patients into the study. 
 
Postoperative data collection 
A daily visit of the study patients will be made by clinical investigators or a delegated 
physician. All protocol-required information collected during the trial will be entered 
into the patient’s record form. Data collected relate to 1) patient characteristics, 2) 
hospitalisation 3) post-operation and 4)complications. The patient characteristics 
collected were: age, weight, height, body mass index (BMI), medical insurance status 
and per-formance status. Hospitalization details included LOS(Length of 
hospitalization post-operation), the procedure performed, diagnosis, operating time, 
name of surgery, intraoperative estimated blood loss. Post-operation details included 
time to full tolerance of free fluids (days), time to full tolerance of solid food (days), 
time to drain removal (days). Complications details included infection(wound 
infection, lung infection, intraperitoneal infection, operation space infection) , 
postoperative nausea and vomiting (PONV), ileus, postoperative hemorrhage, 
postoperative thrombosis and APACHE II  score. (Table 1). 
 
Primary and secondary endpoints 
Primary endpoints 
Length of hospitalization post-operation (d, mean±SD). It was calculated by the 
difference between date of discharge and date of surgery. 
 
Secondary endpoints 
Complications: 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. 
(Table 1). 
 

Ethics, study registration and consent 
This trial was approved by independent ethics committees at Sichuan Cancer Hospital 
and Research Institute 
Board Affiliation: SichuanCHRI 
Phone: +86 02885420681   Email: scchgcp@163.com 
The study procedures, risks, benefits and data management will be clarified with the 
patients before they are asked to give their informed consent to participate. 
 
Study treatment 
The surgical technique is standardized in The treatment team and the patients’ 
families were not blinded to the study. In addition, the data collectors were 
not involved in the clinical management of patients to ensure statistical validity and 
reliability. All surgeries were performed by the same team of surgeons, and the 
patients were treated and nursed by the same treatment team during the peri-operative 
period. Post-operative complications were based on patient complaints and clinical 
symptoms. 
Given there was no Fast-track surgery guideline in the field of gynecological 
oncology surgery , we refer to the guideline of gastrectomy, colorectal surgery 
 and pancreaticoduodenectomy[18-20].(Table1) 
 
Safety aspects 
Gynecological oncology surgery is highly technically demanding procedure. In order 
to avoid bias based on the learning curve of the surgeons, every surgical procedure 
will be performed or supervised by a senior surgeon. And informed consent will be 
obtained from all participants, 
 
Data collected relate to 1) patient characteristics, 2) hospitalisation 3) post-operation 
and 4)complications. The patient characteristics collected were: age, weight, height, 
body mass index (BMI), medical insurance status and per-formance status. 
Hospitalization details included LOS(Length of hospitalization post-operation), the 
procedure performed, diagnosis, operating time, name of surgery, intraoperative 
estimated blood loss. Post-operation details included time to full tolerance of free 
fluids (days), time to full tolerance of solid food (days), time to drain removal (days). 
Complications details included infection(wound infection, lung infection, 
intraperitoneal infection, operation space infection),  ileus, postoperative 
hemorrhage, postoperative thrombosis and APACHE II  score. (Table 2). 
 
 
Methods for avoiding bias  
Minimizing systemic bias  
Patients will be randomized to one of the two groups after admitting diagnosis. 
Randomization will be accomplished using balanced permutation blocks by 
generation of random numbers in order to obtain homogeneity between groups. 
Opaque, sealed envelopes will be produced, labelled with the randomization number 

and containing a sheet that states the group allocation for the patient. Randomization 
envelopes will be used in consecutive order. Basic characteristics of the patient and 
the day of randomization will be documented on a data sheet so that compliance to the 
randomization scheme may be checked retrospectively. If patients are excluded from 
the study after randomization, their numbers will not be reused. Obviously, operating 
surgeons, attending physicians and nursing staff and the patients and families cannot 
be blinded, as the procedure is different. However, outcome assessors will be blinded. 
The randomization process will follow the CONSORT guidelines (Figure 1)[21]. 
 
 
Minimizing treatment bias  
gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, 
hysterectomy add lymphadenectomy and cytoreductive) are standardized in both group，
all surgeons participating in the study are familiar with them. common procedure 
performed on a routine basis, which eliminates a learning curve.  
 
Minimizing measurement bias  
Detection an length of hospitalization post-operation and postoperative complications, 
which are the primary and secondary endpoints, will be based on data in the patient’s 
record form. Blinding is not necessary, because the length of hospitalization post-
operation is an objective endpoint that cannot be influenced by the patient. Physician 
blinding is not possible, because they are involved during surgury. 
 
Statistical methods  
Each patient’s allocation to the analysed population will be defined prior to the 
analysis and will be documented. In the full-analysis set, patients will be analysed as 
randomized according to the intention-to-treat principle. The intention-to-treat 
principle implies that the analysis includes all randomized patients. The per-protocol 
analysis set will include all the patients without major protocol deviation. Deviations 
from the protocol will be assessed as major or minor. Patients with major deviations 
from the protocol will be excluded from the per-protocol analysis. The safety analysis 
set will analyse patients according to the treatment.  
The null hypothesis assumes that the length of hospitalization post-operation and 
postoperative complications is equal in both groups. A binary logistic regression will 
be applied in order to compare length of hospitalization post-operation in the groups 
adjusting for other factors.  
Data were analyzed by SPSS19.0 (SPSS Inc Chicago, Illinois) and expressed as mean
±SD. Length of hospitalization post-operation in the FTS and traditional groups were 
compared and analyzed by Mann-Whitney U-tests (non-normal distribution). 
NRS2002 scores between the two groups were analyzed with the Wilcoxon test 
(nonnormal distribution) or with Student's t-tests (normal distribution). The chi-square 
test or Fisher’s exact test will be used for analysis of categorical secondary 
endpoints (complications). A P-value <0.05 will be considered statistically 
significant. Statistical analyses will be performed using SPSS19.0 (SPSS Inc Chicago, 

Illinois).  
Discussion  
Fast-track surgery (FTS) pathway have been a dopted by most surgical specialties 
worldwide, but in gynecological malignant surgery is sparingly described[22] and 
there are currently no randomized controlled trials to support or refute employing this 
approach[11]. This needs to be explored right now. 
 
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[3, 11, 12]. 
 
Widespread education is needed to improve the rate of implementation of fast-track. 
There are several possible reasons for this, including lack of collaboration in the 
surgical team and lack of awareness of or failure to accept and adopt evidence-based 
findings[8, 9, 23]. Close cooperation between the surgical, anesthesiological and 
nursing staff is essential and the importance of cooperation cannot be overestimated 
as practice needed to achieve further development of surgical care and postoperative 
recovery[24, 25]. Fast-track regimens in general have been well evaluated regarding 
medical complications and they appear to be safe[26].  
 
 
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. 
 
 
Trial status 
At the time of writing, we are about to enroll patients and the anticipated study 
completion date is April 2017. 
 
Abbreviations 
Abbreviations 
Definition 
FTS 
Fast-track surgery 
LOS 
Length of hospitalization post-
operation 
PONY 
postoperative nauseaand vomiting  
APACHE II score 
Acute Physiology and Chronic 
Health Evaluation II 
 
Competing interests 
The authors declare that they have no competing interests. 

Author's contribution: Ling. Cui conceived of the study, design of the study and 
performed the statistical analysis and drafted the manuscript. Yu. Shi participated in 
the design of the study and performed the statistical analysis. Guonan Zhang 
participated in its design and coordination and helped to draft the manuscript. All 
authors read and approved the final manuscript.” 
 
Acknowledgements 
We would like to acknowledge Dr. Tan Chunlu, 
Department of Pancreatic Surgery, West China Hospital, Sichuan University, Chengd
u 610041, Sichuan Province, China,for consultation and inspiration. 
 
References 
[1] 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;345:763-4. 
[2] Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Annals 
of surgery. 2008;248:189-98. 
[3] Acheson N, Crawford R. The impact of mode of anaesthesia on postoperative recovery from fast-
track abdominal hysterectomy: a randomised clinical trial. BJOG : an international journal of obstetrics 
and gynaecology. 2011;118:271-3. 
[4] Yoong W, Sivashanmugarajan V, Relph S, Bell A, Fajemirokun E, Davies T, et al. Can enhanced 
recovery pathways improve outcomes of vaginal hysterectomy? Cohort control study. Journal of 
minimally invasive gynecology. 2014;21:83-9. 
[5] Carter J, Szabo R, Sim WW, Pather S, Philp S, Nattress K, et al. Fast track surgery: a clinical audit. 
The Australian & New Zealand journal of obstetrics & gynaecology. 2010;50:159-63. 
[6] Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. 
Langenbeck's archives of surgery / Deutsche Gesellschaft fur Chirurgie. 2011;396:585-90. 
[7] Verheijen PM, Vd Ven AW, Davids PH, Vd Wall BJ, Pronk A. Feasibility of enhanced recovery 
programme in various patient groups. International journal of colorectal disease. 2012;27:507-11. 
[8] Kehlet H. Multimodal approach to postoperative recovery. Current opinion in critical care. 
2009;15:355-8. 
[9] Kehlet H. Fast-track colorectal surgery. Lancet. 2008;371:791-3. 
[10] Philp S, Carter J, Pather S, Barnett C, D'Abrew N, White K. Patients' satisfaction with fast-track 
surgery in gynaecological oncology. European journal of cancer care. 2015;24:567-73. 
[11] Lu D, Wang X, Shi G. Perioperative enhanced recovery programmes for gynaecological cancer 
patients. The Cochrane database of systematic reviews. 2015;3:CD008239. 
[12] Lv D, Wang X, Shi G. Perioperative enhanced recovery programmes for gynaecological cancer 
patients. The Cochrane database of systematic reviews. 2010:CD008239. 
[13] Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. American journal of 
surgery. 2002;183:630-41. 
[14] Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, et al. Enhanced 
recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. 
Clinical nutrition. 2005;24:466-77. 
[15] 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. Journal of the American College of 
Surgeons. 2010;210:93-9. 
[16] Carter J. Fast-track surgery in gynaecology and gynaecologic oncology: a review of a rolling clinical 
audit. ISRN surgery. 2012;2012:368014. 
[17] Lin YS. Preliminary results of laparoscopic modified radical hysterectomy in early invasive cervical 
cancer. The Journal of the American Association of Gynecologic Laparoscopists. 2003;10:80-4. 
[18] Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, et al. Consensus guidelines for 
enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society 
recommendations. The British journal of surgery. 2014;101:1209-29. 
[19] Williamsson C, Karlsson N, Sturesson C, Lindell G, Andersson R, Tingstedt B. Impact of a fast-track 
surgery programme for pancreaticoduodenectomy. The British journal of surgery. 2015;102:1133-41. 
[20] Bona S, Molteni M, Rosati R, Elmore U, Bagnoli P, Monzani R, et al. Introducing an enhanced 
recovery after surgery program in colorectal surgery: a single center experience. World journal of 
gastroenterology : WJG. 2014;20:17578-87. 
[21] Moher D, Schulz KF, Altman DG, Consort G. The CONSORT statement: revised recommendations 
for improving the quality of reports of parallel-group randomized trials. Annals of internal medicine. 
2001;134:657-62. 
[22] Marx C, Rasmussen T, Jakobsen DH, Ottosen C, Lundvall L, Ottesen B, et al. The effect of 
accelerated rehabilitation on recovery after surgery for ovarian malignancy. Acta obstetricia et 
gynecologica Scandinavica. 2006;85:488-92. 
[23] Polle SW, Wind J, Fuhring JW, Hofland J, Gouma DJ, Bemelman WA. Implementation of a fast-track 
perioperative care program: what are the difficulties? Digestive surgery. 2007;24:441-9. 
[24] 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 opinion on 
pharmacotherapy. 2008;9:1541-64. 
[25] 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. Quality & 
safety in health care. 2009;18:236-40. 
[26] Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta 
obstetricia et gynecologica Scandinavica. 2013;92:17-27. 
 
Table 1 Procedure-specific management 
 
FTS management 
Traditional management 
Pre-operative 
pre-operative assessment, counseling 
and FT management education 
pre-operative fasting at 
least 8h 
 
Preoperative nutritional drink up to 4 h 
prior to surgery 
mechanical bowl preparation should not 
be used 
Oral bowel 
preparationor  
or mechanical bowl 
until liquid stool 
 
patients are not received mechanical 
bowel preparation, only oral intestinal 
cleaner 12 h pre-operation can be 
accepted, but no need of liquid stool 
Antimicrobial 
prophylaxis and 
skin preparation 
 
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 the 
intra-operative coretemperature at 36 
±0.5℃ 
34.7±0.6℃ 
 
Antiemetics at end of anaesthesia 
 
Post-
operative 
Postoperative glycaemic control 
 
 
postoperative nausea and vomiting 
(PONV) control 
 
 
Early postoperative diet(3-6 h after 
surgery, patients resumed a liquid diet, 
12 h after surgery patients began to take 
solid diet) 
6 h after surgery, 
patients resumed a 
liquid diet, 
patients began to take 
solid diet after anal 
exhaust 
audit  
 
Systematic audit improves compliance 
and clinical outcomes 
 
 
Table 2 Clinical parameters and postoperative complications for analysis 
Parameters 
Definitions 
patient characteristics 
age, weight, height, body mass index (BMI), 
medical insurance status and per-formance status. 
hospitalisation 
LOS(Length of hospitalization post-operation), the 
procedure performed, diagnosis, operating time, 
name of surgery, intraoperative estimated blood loss 
Post-operation 
time to full tolerance of free fluids (days), time to 
full tolerance of solid food (days), time to drain 
removal (days). 
Complications 
 
infection 
wound infection, lung infection, intraperitoneal 
infection, operation space infection 
postoperative nausea and 
vomiting (PONV) 
it was recognized that nausea and vomiting are 
common side effects of surgical recovery 
Ileus 
 is a disruption of the normal propulsive ability of 
the gastrointestinal tract 
Postoperative haemorrhage 
Evidence of blood loss from drains or based on 
ultrasonography 

Postoperative thrombosis 
 
Evidence of blood thrombosis based on 
ultrasonography 
APACHE II  score 
Acute Physiology and Chronic Health Evaluation II 
 
Figure1  Study flow diagram