Safety and Efficacy of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Emergency Laparotomy: A Single Center Randomized Controlled Trial
Phase: NA
Conditions: Acute Abdomen, Abdominal Trauma, Emergency Surgery
Sponsor: Tianjin Medical University

Safety and efficacy of enhanced recovery after surgery 
(ERAS) in patients undergoing emergency laparotomy: 
A single center randomized controlled trial 
 
 
 
 
 
 
 
 
 
 
Brief title: Enhanced Recovery After Surgery (ERAS) in patients 
undergoing emergency laparotomy 
Organization’s Unique Protocol ID:   023-YLS-010   
Study Type:  Clinical trial    
Central Contact Person:    Jianing Lu    
Study Locations:    China, Tianjin    
Document Date:    October 20,2023    
 
 
 
 
 
 
 
 
Tianjin Medical University Surgery Student Research 
Network 
 

Research proposals 
1.Affirmation of 
Integrity 
All the researchers involved in this study solemnly declare their 
commitment to strict adherence to the experimental protocols and 
the authenticity of the data records throughout the entire phase of 
the study. They also promise not to have any conflict of interest. 
2. Research Title 
Safety and efficacy of enhanced recovery after surgery (ERAS) in 
patients undergoing emergency laparotomy: A single center 
randomized controlled trial 
3. Research plan 
1. August 2023-October 2023  Refine ERAS-related measures and 
coordinate the work of relevant sections of the agency； 
2. November 2023-April 2024  In accordance with the study plan 
and randomization process, the study subjects were included and 
the study was completed 
3. May 2024-June 2024  Collect experimental data and complete 
statistical analysis of the experiment 
4. July 2024-April 2024 Completion of thesis writing and publication 
4. Background 
  Since Kehlet first proposed enhanced recovery after surgery 
(ERAS) protocols in the 1990s, they have been widely adopted. 
Preoperative counseling, standardized anesthesia management 
protocols, more optimal postoperative analgesic regimens, restriction 
of intubation and catheterization, early postoperative mobilization, 
and early oral intake of food are all part of ERAS programs. These 
programs began in colorectal surgery and have now been expanded 
to other surgical specialties. Several studies have shown that 
patients benefit from ERAS programs, including reduced pain, faster 
return to bowel function, shorter hospital stays, and lower health 
care costs. However, we found that ERAS programs are rarely used 
for emergency surgery. 
 Emergency surgery is the treatment of choice for acute abdominal 
conditions such as traumatic liver rupture, traumatic splenic rupture, 
and complete bowel obstruction. Nevertheless, we found that most 
clinical studies of ERAS excluded patients who underwent 
emergency surgery. This is because most researchers probably 
believe that emergency surgery does not allow enough time for 
ERAS-related preoperative preparation. In fact, some ERAS 
programs can be used for emergency surgery, such as the 
anesthetic modality of combined anesthesia, postoperative 
multimodal analgesia, earlier postoperative oral feeding and 
ambulation, and earlier removal of invasive catheters. However, few 
studies have focused on the use of ERAS in emergency surgery. 
 The present study is a randomized controlled trial evaluating the 
safety and efficacy of an ERAS program in emergency abdominal 
surgery. We hypothesized that an ERAS program could be 

implemented into emergency surgery and reduce postoperative 
recovery time without increasing the complication rate and 
readmission rate (<30 days). 
5.esearch purpose 
1. Exploring the impact of accelerated rehabilitation surgery on 
postoperative recovery in patients undergoing open surgery for 
acute abdomen;.  
2. Evaluating the safety of accelerated rehabilitation surgery in 
patients undergoing open surgery for acute abdominal conditions.  
3. Evaluating the impact of accelerated rehabilitation surgery on 
complications in patients undergoing open surgery for acute 
abdominal conditions。 
6.Inclusion and 
exclusion criteria 
Inclusion criteria: 
1. patients between the ages 18-70, 
2. patients who completed the preoperative examination and 
preoperative diagnosis within 4 hours after admission for acute 
abdomen diseases, 
3. required emergency surgery within 6 hours from surgeon 
encounter. 
Exclusion criteria 
1. patients who refused to be enrolled in this study;  
2. patients with any psychiatric or neurological disorders;  
3. septic shock at admission;  
4. duration of symptoms more than five days;  
5. patients with contraindications to the placement of lumbar 
epidural catheters, such as coagulation disorders, severe sepsis, etc.; 
6. presence of preoperative factors affecting wound healing (e.g. 
long-term steroid use);  
7. patients with extra-abdominal injuries or terminal malignancy, or 
patients requiring damage control surgery;  
8. patients found intraoperatively to require any procedure other 
than splenectomy, partial hepatectomy or liver repair, bowel 
resection and anastomosis, laparoscopic cholecystectomy and 
appendectomy, and gastrointestinal perforation repair. 
7. Design proposal 
This study was a continuous, two-arm, randomized, single-blind, 
controlled trial. 
8.Sample size 
estimation 
The primary outcome was postoperative recovery time, which 
required a power analysis. For this purpose, we reviewed the medical 
records of patients with acute abdomen who underwent emergency 
surgery between January 2013 and January 2023 at our hospital. The 
mean postoperative recovery time for these patients was 13.7 ± 2.1 
days. Two days was determined to be a clinically significant 
difference. The power of the test was set at 90% and the significance 
level was set at 5%. Based on these facts, the required sample size 
was calculated as 72 cases per group. To increase the power of the 

study, the recruitment process was extended until there were a total 
of 80 patients in each group. 
9.Methods of 
randomized and 
hidden grouping 
Using SAS Statistical Package version 9.3, independent investigators 
created random numbers in a 1:1 ratio with a block size of 4. 
Patients were stratified according to the type of surgery. A study 
coordinator not associated with patient enrollment, information 
collection, perioperative treatment, or postoperative follow-up will 
enclose the randomization results in sequentially numbered 
opaque envelopes. Prior stratified randomization was performed 
according to four types of surgery: hemorrhagic trauma (traumatic 
liver or spleen rupture), gastrointestinal reconstruction (complete 
gastrointestinal obstruction), inflammatory disease (acute 
cholecystitis and appendicitis), and perforated disease. After the 
surgeon decided to proceed with the operation, the study 
coordinator opened the envelopes and assigned the groups. In this 
way, all patients enrolled in the study were randomly assigned to 
receive either the ERAS program (ERAS group) or usual care (usual 
group). 
 In the event of a serious adverse event or any unanticipated 
deterioration in a patient's clinical status, group assignment could 
be unblinded to ensure patient safety. The case report form was 
used to record these events. Unblinded patients were included in 
the intention-to-treat population but were not included in the per-
protocol analysis. 
10.Blind 
single-blind 
11.Outcomes 
Primary outcome: postoperative recovery time. 
Secondary outcomes: (1) postoperative recovery rate; (2) 
postoperative complication rate (evaluated by Clavien-Dindo 
classification); (3) time to first postoperative bowel movement; (4) 
time to tolerate a semi-liquid diet; (5) time to tolerate a soft food 
diet; (6) re-admission rate (within 30 days); (7) maximal pain score 
determined by a visual analog scale (VAS)13; (8) patient satisfaction, 
evaluated with the Inpatient Satisfaction Scale developed by Peking 
Union Medical College Hospital. 
12.Definition of 
participant validity 
determination 
In the event of a serious adverse event or any unforeseen 
deterioration in the patient's clinical status, group allocation could 
be unblinded and the trial withdrawn to ensure patient safety. A case 
report form was used to record these events. Unblinded patients 
were included in the intention-to-treat population but were not 
included in the per-protocol analysis. 
13.Definition of 
adverse events 
and adverse 
reactions, 
1. Adverse events: adverse medical events that occurred during the 
course of the study, but not necessarily related to ERAS-related 
measures. 
2. Identification method: the occurrence of postoperative 

identification 
methods and 
management 
systems 
complications was evaluated according to the Clavien-Dindo 
classification. 
3. Management system: In the event of a serious adverse reaction or 
any unforeseen deterioration of the patient's clinical status, group 
allocation could be unblinded and the trial withdrawn to ensure 
patient safety. Case report forms were used to record these events. 
Unblinded patients were included in the intention-to-treat 
population but were not included in the per-protocol analysis. 
14. Recruitment of 
participants 
The recruitment site was the institution where this study was 
conducted, and at the time of admission, investigators screened 
potential patients for acute abdominal diseases. These acute 
abdominal conditions included: hemorrhagic trauma (traumatic liver 
or 
spleen 
rupture), 
gastrointestinal 
obstruction 
(complete 
obstruction), and inflammatory perforating disease. After screening 
was completed, patients who met the inclusion and exclusion criteria 
were informed about the experiment and signed an informed 
consent form. 
15.Collection of 
general 
information on 
participants 
After obtaining informed consent from the patients, baseline 
information (demographics, surgical data, type of surgery, 
comorbidities, history of previous abdominal surgery) was collected. 
The investigators who undertook the preoperative selection, 
information collection, and evaluation were professional and 
qualified prior to the trial. 
16.Baseline 
indicators and 
observational 
projects 
Age, gender, BIM, history of previous abdominal surgery, 
comorbidities, ASA classification, duration of surgery, type of 
surgery, intraoperative blood loss 
17.Standard 
Operating 
Procedures 
Preoperative care: A number of preoperative protocols were similar 
in both groups, including: (1) surgical risk assessment; (2) 
preoperative placement of a nasogastric tube (NG); (3) preoperative 
administration of crystalloid fluids to replenish blood volume; (4) 
empiric antibiotics and acid-reducing therapy administered 
intravenously; and (5) intravenous analgesia. 
 In the ERAS group, an epidural catheter was placed in the lumbar 
3-4 space before surgery to facilitate intraoperative epidural 
anesthesia and postoperative analgesia. At the same time, 
ultrasound-guided internal jugular vein (IJV) cannulation was 
performed to monitor central venous pressure (CVP). CVP-guided 
infusion, i.e., goal-directed fluid therapy, was maintained at a CVP of 
8-10 cm of saline. Depending on the urinary output, blood pressure, 
heart rate, and clinical signs of dehydration, fluids were administered 
according to an institutional care plan in the routine care group. 
Dexamethasone 4 mg IV was given shortly before induction of 
anesthesia. 

  Intraoperative care: All patients underwent emergency open 
surgery. Appropriate surgical incisions were selected based on 
adequate provision of good surgical vision and surgical space. If 
intra-abdominal fluid was found, it was aspirated and sent for 
bacterial culture. The final decision on the surgical approach is based 
on the surgeon's opinion and intraoperative findings. If anastomosis 
was deemed unsafe, an ileostomy without anastomosis was 
performed. Table 1 shows the changes in the anesthesia regimen in 
the ERAS group. The anesthesiologist decided the anesthesia for the 
conventional group. In the ERAS group, an experienced surgeon set 
up an abdominal drain as needed during the procedure. In the 
conventional care group, an abdominal drain was routinely placed. 
  Postoperative care: The postoperative drinking and eating 
schedules for both groups can be seen in Table 1.Patients in the 
ERAS group were asked to start simple bed activities, such as moving 
both lower limbs, on the day of surgery (POD-0), provided that the 
epidural catheter was secure. At POD-1, patients were asked to sit 
for at least 2 hours and then get out of bed after the epidural 
catheter was removed at POD-2. In the conventional group, patients 
were encouraged to be active at POD-2, starting with simple bed 
activities and gradually transitioning to normal walking without any 
specific requirements. 
18.Methods of 
statistical analysis 
SPSS (version 19.0) and GraphPad Prism (version 8.0) software were 
used for statistical analysis. Independent samples t-test (Student's t-
test) was used to compare continuous data with normal distribution. 
Independent samples Mann-Whitney U test compared continuous 
data with non-normal distribution. Comparisons between groups of 
categorical variables were made using the Chi-square test, Fisher's 
exact test, χ2 test, or continuity-corrected χ2 test. Continuous 
variables were expressed as mean and standard deviation (Mean SD). 
Logit tests stratified by randomization parameters were used to 
compare primary and secondary outcomes across groups. For 
comparisons of postoperative recovery time, the stratified Cochran-
Mantel-Haenszel test was utilized without adjustment for multiple 
comparisons. P＜0.050 
19. Data 
management 
system 
Data collection and recording was carried out by a regular 
independent investigator who was not involved in the entirety of this 
study