1

Introduction

Fast-track surgery was first published as a concept in 1994 by Engelman et al. , and shortly thereafter remarkable results in recovery time were published by Kehlet et al. in 1995 and 1999. ^, The Enhanced Recovery After Surgery (ERAS) project was initiated in the year 2000.

An enhanced recovery program (ERP) represents a milestone in surgical care. The feasibility of ERP and its benefit on short-term outcomes have been widely reported. Enhanced Recovery has been strongly applied to colorectal surgery. Nowadays, guidelines regarding gastric, pancreatic, gynecology, bariatric, hepatic, and urologic surgery are available.

The main purpose of establishing Fast Track procedures was to verify an earlier recovery following surgery. It has become common practice to shift from “faster” to “enhanced” thinking: the cornerstone of ERP was formed by adjusting the Surgical Stress Response (SSR). There has been much discussion over the years regarding the biological systems and mechanisms involved in the stress response. The immune, neuroendocrine, and metabolic systems react as expected after surgery. Patients experience elevated catecholamine levels, tachycardia, hypertension, and tachypnea. Pro-inflammatory cytokines such as interleukin (IL)-1, IL-6, IL-8, C-reactive protein (CRP), and tumor necrosis factor (TNF) alpha are synthesized as a result of the cellular response. CRP and postoperative IL-6 are helpful indicators for determining the extent of surgical damage.

ERAS protocols are multimodal perioperative care protocols that apply evidence-based medicine to reduce the length of the hospital stay and postoperative complications. Laparoscopic cholecystectomy (LC), considered the gold standard treatment of gallstone disease, is the most common surgery performed worldwide (1.3million LCs were performed in the USA in the calendar year 202,1 ), including the part of the world, and the institution where this study was performed. LC is being established as a day care procedure with some success, hence, we aimed to study the use of a modified ERAS program in the perioperative period in patients who underwent laparoscopic cholecystectomy procedures concerning stress response, postoperative complications, and postoperative rehabilitation.

2

Materials & methods

This prospective observational study was conducted in consecutive patients (both female and male) of all age groups undergoing laparoscopic cholecystectomy in the Department of General Surgery in a North Indian tertiary care center. This study followed the “Strengthening the Reporting of Observational Studies in Epidemiology” (STROBE) guidelines for reporting the observations. Patients admitted in the elective ward with symptomatic cholelithiasis and planned for elective cholecystectomy, without any prior comorbidity, and whose Laparoscopic cholecystectomy happened without any intraoperative surgical complications (Intraoperative complications will increase the operative time and change the stress response of the body. Moreover, the operative plan might get changed from LC to some other surgery like open cholecystectomy which would alter the post-operative plan, hence complications were excluded), and those who gave consent to participate in the study were included. Patients with a history of diabetes mellitus, thyroid dysfunction, heart failure, chronic renal failure, or chronic obstructive pulmonary disease, pregnant females, those facing any intraoperative surgical complications, those with recent attacks of severe pain in the abdomen, and those not giving consent to be part of the study, were excluded from our study. What is noteworthy here is the fact that by excluding this important subset of patients, the authors do not imply that the ERAS protocol doesn’t work in patients with comorbidities. Preoperative glucose administration with large volume fluid would lead to deranged blood sugars in diabetics, increased blood pressure, and might precipitate heart failure in patients with known heart diseases. As a first-stage study, the authors wanted to perform it on normal-seeming patients. The complex response in patients with heart failure and other comorbidities needs to be studied separately, hence they were excluded.

A detailed comprehensive history was obtained of pre and postoperative laparoscopic cholecystectomy evaluation along with other associated comorbidities. Preoperative B mode-ultrasonography of the abdomen, abdominal computerized tomography (CT), or abdominal magnetic resonance imaging (MRI) was performed in all patients to confirm the pathology.

Patients were divided into two groups using a random number generator: 50.0 % were applied to the ERAS protocol (case group), and the remaining 50.0 % were treated following the standard protocol (control group). All procedures were performed by the same team of surgeons and healthcare workers. The anesthesiologic and surgical procedures were unchanged, and laparoscopic cholecystectomy with the four-hole method was performed.

Patients in the traditional perioperative treatment plan group were treated with a standardized fast-rehabilitation surgical protocol and a fast-rehabilitation surgical nursing schedule, already being practiced in the hospital where the study was performed.

In the ERAS protocol group, preoperatively, in addition to routine preoperative conversations, preoperative information and education were imparted to the patients about the purpose and main measures of the ERAS program to increase compliance with the program. The patients were informed about the anesthesiologic and surgical methods, their fears and anxiety about the anesthesia and the surgery were reduced, and they were informed about the discharge standards and other related matters. Additionally, the patients fasted for 6 h and received a 250-mL oral 10 % glucose solution 2 h before surgery. Intra-operatively, patients were given general anesthesia combined with regional block anesthesia. The carbon dioxide pneumoperitoneum pressure was controlled at 10–12 mmHg. Postoperatively, patients received infiltration anesthesia with ropivacaine at the puncture site in combination with intramuscular injections of opioids (morphine or dezocine) to relieve pain after surgery. An antiemetic agent (metoclopramide) was used to prevent nausea and vomiting. The volume of fluid infusion was controlled at 1000–1500 mL/day until 1– 2 days after surgery. The patients could drink water and consume liquid nutrients 6 h after surgery and were gradually transitioned to a normal diet. After awakening from anesthesia, the patients began to move in bed and got out of bed 6–8 h after surgery. The drainage tube was routinely placed during the operation until the volume of drainage fluid was <30 mL/day. The T tube was removed 2 weeks after the operation.

All patients included in the study were investigated according to the following parameters—Serum glucose levels just before the operation, within 1 h of the postoperative period, and 6 h of the postoperative period; and Serum cortisol level just before the operation, and within 1 h of the post-operative period. To assess stress response indicators, venous blood was drawn from the elbow in the morning while the patient was fasting, 1 day before and after surgery, to measure the total leukocyte count (TLC) and C-reactive protein (CRP) levels. To evaluate postoperative side effects, the incidence of complications, like nausea and vomiting, incisional pain, fever, jaundice, and wound infection were noted. Additionally, the Post Operative Nausea and vomiting (PONV) intensity scale was used for scoring the occurrence of the same.

Data was presented as proportions, median (range), or mean (± standard deviation), as appropriate. The independent-sample t -test was used for comparisons between groups, and the chi-square test was used for the comparison of count data. Differences were considered to be statistically significant at p < 0.05.

The study was performed after being approved by the Institutional Ethics Committee.

3

Results

A total of 120 patients were included in our study, out of which 60 belonged to the case group, and 60 to the control group. The average age of the patients was 35.56±15.78 years. Out of the 120 patients, 112 (93.33 %) were females. 104 (86.66 %) patients were homemakers and 118 (98.3 %) lived in rural areas. The groups were comparable in terms of age, gender distribution, occupation, and area of residence ( Table 1 ).

The variations in the preoperative serum Glucose levels, serum Glucose levels just before operation, and serum Glucose levels at 6 h post-operative were significantly higher in the case group as compared to the control group ( p < 0.001 in all three parameters) ( Table 2 ).

Table 2

Serum Glucose levels in both groups.

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