Abstract
According to recent clinical practice guidelines, enhanced recovery programs (ERP) have been practiced to improve surgical outcomes and decrease cost. However, these are still opposed by the traditional measures in the treatment of colorectal carcinoma that is still practiced with the concept of protection of anastomosis and decrease postoperative complications. The aim of this study was to report our experience in ERP in elective open left side colonic carcinoma surgery in comparison with the conventional perioperative care. The current prospective multicenter randomized controlled study included a total of 80 adult patients with left side colonic cancer who were eligible for elective colonic resection. Included patients were randomly divided into two equal groups: group (A) where conventional perioperative care was performed and group (B) where ERP were applied. Follow-up was designed for at least 1 month to evaluate and compare hospital stay and postoperative complications. There was no statistically significant difference between the two groups as regards demographic data and preoperative comorbidities. There were statistically significant less pain (P = 0.24), less postoperative nausea and vomiting (P = 0.045), and less hospital stay (P < 0.001) in group B than group A. Otherwise, there was no statistically significant difference in comparing the rest of postoperative surgical or non-surgical complications or rates of readmissions between the two groups. ERP are safe, reliable, simple, and applicable in open left side cancer colon surgery with no negative impact over the postoperative complications in comparison with the conventional care.
Keywords: Left side colon cancer, Enhanced recovery programs, Perioperative care
Introduction
Colorectal cancer (CRC) is the third most commonly diagnosed malignancy and the fourth leading cause of cancer death in the world [1]. The colon is split into right and left portions based on the splenic flexure; each part is different in its embryological origin and shows different physiologic features. Accordingly, in different treatment options [2], surgery is the mainstay of treatment of colon cancer, providing definitive management and potential cure in early cases and effective palliation in advanced cases [3]. Conventional colorectal operations for the malignant disease are usually associated with extensive preoperative preparation, significant surgical stress, and prolonged recovery of gastrointestinal function [4]. Traditional protocols in the management of surgical cases of colorectal cancers are still practiced in some organizations, with the concept of early nutrition will delay the intestinal function recovery and the placement of intra-abdominal drains will guard against leakage. The consequently prolonged hospital stay is thereafter not only due to problems of morbidity but to the followed protocol of conventional care. For decades, these protocols have not been modified [5].
Enhanced recovery programs (ERP) have been evolved aiming to improve perioperative optimization, reduce the incidence of postoperative complications, and decrease the hospital stay and cost [6]. The enhanced recovery program was previously known as fast-track surgery or enhanced recovery after surgery (ERAS). It comprises a group of standardized perioperative practices and procedures that could be applied to all patients eligible for elective surgery [7]. These programs were designed to improve the postoperative outcomes including nausea, vomiting, and pain and to enhance the early return of bowel function, without an increase in the incidence of postoperative complications [8].
The components of ERP include preoperative, intraoperative, and postoperative protocols. All elements in ERAS separately have been shown to improve patient outcome [9]. However, it is difficult to recognize the most beneficial component of those measures that is why all measures of ERP must be applied to achieve the required outcome [10].
The aim of this study was to compare the impact of the ERP on the postoperative outcome after open elective left colonic carcinoma surgery in comparison with the conventional perioperative care.
Patients and Methods
The study was conducted at the Surgery Departments of the University Main Hospitals in Benha, Menoufia and Tanta Faculty of Medicine, throughout the period from March 2016 until January 2019. Approval to conduct the research was obtained from institutes’ ethical and research committees. The study included 80 patients who were diagnosed as stage I or II left colonic carcinoma and are eligible for elective resection: sigmoidectomy, left hemicolectomy, or extended left hemicolectomy. Exclusion criteria included patients with advanced, perforated, or obstructed left-sided colon cancer. Immunocompromised patients or those with ASA score more than 3, bleeding tendency or contraindication to regional anesthesia, were also excluded.
A written informed consent was obtained from all included patients. Patients were randomized by computer-generated random allocation software into two equal groups: A and B. Patients in group A were managed using conventional perioperative care and those of group B patients were managed using ERP. All patients included in this study were subjected to complete history taking, full clinical examination, and full preoperative investigations, including colonoscopy and biopsy as well as complete metastatic workup.
Group A
Patients were subjected to the traditional care including preoperative anesthetic assessment, admission 2 days before surgery with full colonic preparation, antibiotics, prophylactic subcutaneous heparin, and fasting for 8 h before surgery. Intraoperative measures included the use of general anesthesia that was induced with propofol and rocuronium and maintained with sevoflurane inhalation without nitrous and intermittent injection of rocuronium or cisatracurium. Narcotics were used for analgesia. Routine insertion of the nasogastric tube as well as intraperitoneal drains. Postoperative care included NPO until the third postoperative day where oral fluids followed by regular diet were allowed. Mobilization on demand with the help of the nursing staff was performed. Postoperative pain control was applied using paracetamol infusion together with ketoprofen.
Group B
Parameters of ERP according to recent guidelines [6, 7] were applied. Preoperative anesthesia assessment and optimization were mandatory together with proper identification of the high-risk patients that may develop postoperative nausea and vomiting. All patients were admitted without mechanical colonic preparation; however, the enema was only applied early morning on the day of surgery. The nutritional status was optimized using carbohydrates rich fluids up to 2 h before surgery. Fasting hours were planned to be 6 h for solid food and only 2 h for fluids. A prophylactic dose of antibiotics and 40 mg of subcutaneous heparin was administrated to all patients. Wearing of elastic stocking was mandatory.
Intraoperative measures included conduction of anesthesia and analgesia after patient monitoring, securing IV lines, starting fluids, and administration of antiemetic drugs according to predetermined patient risks. Patients within this group received combined epidural general anesthesia. Epidural puncture and catheterization were performed in one of the intervertebral spaces from T7 to T10 according to the position of the planned surgical incision; then, the infusion was maintained with 0.1% bupivacaine and 2–5 mic/mL of fentanyl. Then, general anesthesia was induced and maintained as in group A. The use of narcotics was minimized and replaced by acetaminophen and/or NSAID as per patient’s needs. The intraoperative temperature was monitored and maintained throughout the whole surgical procedure. Esophageal Doppler was used to monitor intraoperative volume status and determine the amount of fluids to be administrated to maintain the patient euvolemic. Administration of intravenous dexamethasone at induction and ondansetron at the end of surgery was mandatory in a high-risk patient for the development of postoperative nausea and vomiting (PONV). Neither intraperitoneal drains nor a nasogastric tube was used. Postoperative pain control was achieved through patient-controlled epidural analgesia. It was established with 250 mL of 0.1% bupivacaine and 2 μg/mL of fentanyl that was programmed to be delivered as a 2 mL bolus with a lockout interval of 20 min and a background infusion of 4 mL/h.
Postoperative nausea and vomiting were monitored and aggressively treated using dexamethasone and antiemetic drugs. Postoperative oral intake started once the intestinal sounds were audible by allowing clear fluids then full liquid diet on the first postoperative day and normal diet on the second day as tolerated. Enhancement of early ambulation was advised for 4 h in the first postoperative day, 6 h in the second day, and 8 h for the subsequent days.
All patients in both groups were evaluated for postoperative pain by visual analogue scale (VAS) and early postoperative complications including, PONV, ileus, intestinal obstruction, wound infection, abdominal dehiscence, anastomotic leakage, intraperitoneal abscess, or peritonitis. Also, postoperative non-surgical complications as cardiopulmonary complications and electrolyte imbalance were monitored and recorded. The postoperative hospital stay and the number of readmission were estimated within 30 days postoperatively.
Statistical analysis was performed using Student’s “t” test for quantitative parameters that were described using range (minimum and maximum) and mean and standard deviation. The chi-square test was used for qualitative parameters that were described as the frequency with percent. SPSS-20 (Statistical Package for Social Sciences version 21) was used. Probability values of less than 0.05 were considered significant.
Results
The current study included 80 patients with left side colonic cancer who had undergone elective colectomy. The randomized patients into the two assigned groups did not show statistically significant differences regarding demographic data, social habits, nor preoperative comorbidities, namely ischemic heart disease (IHD), hypertension (HT), diabetes mellitus, or previous history of deep vein thrombosis (DVT), as shown in Table 1. Restoration of gut continuity after colonic resection has been performed by hand sewn anastomosis in 34 (85%) patients in group A and 33 (82%) patients in group B, while stapler was used for the rest of the patients in both groups, with no statistically significant difference(P = 0.762). The operative time for group B ranged from 125 to 190 min with a mean of 155.2 ± 15.1 min that was significantly shorter than group A that ranged from 135 to 185 min with a mean of 162.9 ± 12.7 (P = 0.016).
Table 1.
Socio-demographic data and preoperative comorbidities
| Patients | Conventional (n = 40) | ERP (n = 40) | Test of Sig. | p | |
|---|---|---|---|---|---|
| Sex | Male | 20 (50%) | 20 (50%) | χ2 = 0.000 | 1.000 |
| Female | 20 (50%) | 20 (50%) | |||
| Age (years) | Median (min– max) | 50 (31–66) | 52 (27–66) | t = 0.083 | 0.934 |
| Mean ± SD | 49.7 ± 8.4 | 49.5 ± 10.4 | |||
| BMI (kg/m2) | Median (min–max) | 31 (26–39) | 31 (24–41) | t = 0.458 | 0.648 |
| Mean ± SD | 31.7 ± 3.0 | 32.1 ± 4.6 | |||
| Smoking | 18 (45%) | 16 (40%) | χ2 = 0.205 | 0.651 | |
| Medical history | IHD | 5 (12.5%) | 3 (7.5%) | χ2 = 0.556 | 0.712 |
| HTN | 11 (27.5%) | 10 (25%) | χ2 = 0.065 | 0.799 | |
| DM | 9 (22.5%) | 7 (17.5%) | χ2 = 0.313 | 0.576 | |
| DVT | 1 (2.5%) | 2 (5%) | χ2 = 0.346 | 1.000 | |
As shown in Table 2, patients in group B experienced significantly less pain than group A (P = 0.024). There was no statistically significant difference in comparing both groups regarding postoperative surgical nor non-surgical complications except for PONV that was significantly less in group B than group A (P = 0.045).
Table 2.
Pain and postoperative complications
| Conventional (n = 40) | ERP (n = 40) | Test of Sig. | p | ||
|---|---|---|---|---|---|
| Pain (VAS) scale | Median (min–max) | 4.5 (3–6) | 3 (2–5) | U = 574.50* | 0.024* |
| Mean ± SD | 4.6 ± 0.7 | 3 ± 1.2 | |||
| Surgical complications | PONV | 15 (37.5%) | 7 (17.5%) | χ2 = 0.0451 | 0.045* |
| Ileus | 6 (15%) | 5 (12.5%) | χ2 = 0.105 | 0.745 | |
| Anastomotic leak | 3 (7.5%) | 3 (7.5%) | χ2 = 0.000 | 1.000 | |
| Wound infection | 4 (10%) | 3 (7.5%) | χ2 = 0.157 | 1.000 | |
| Abdominal dehiscence | 3 (7.5%) | 2 (5%) | χ2 = 0.213 | 1.000 | |
| Bowel obstruction | 2 (5%) | 2 (5%) | χ2 = 0.000 | 1.000 | |
| Intra-abdominal abscess/peritonitis | 1 (2.5%) | 1 (2.5%) | χ2 = 0.000 | 1.000 | |
| Non-surgical complications | Cardiopulmonary | 5 (12.5%) | 4 (10%) | χ2 = 0.125 | 1.000 |
| Electrolyte imbalance | 1 (2.5%) | 1 (2.5%) | χ2 = 0.000 | 1.000 | |
* (statistically significant)
The hospital stay was calculated from the day of admission until the day of discharge together with the readmission days. As shown in Table 3, there was a significantly shorter hospital stay in group B than group A, with no difference in the number of readmissions between the two groups. The mean number of readmission days was slightly higher in group B (5.8 ± 1.3 days) than group A (4.8 ± 0.8 days) but still no statistically significant difference was observed.
Table 3.
Hospital stay and readmission
| Conventional (n = 40) | ERP (n = 40) | Test of Sig. | p | ||
|---|---|---|---|---|---|
| Hospital stay | Median (min–max) | 7 (6–14) | 5 (3–9) | U = 200.00* | < 0.001* |
| Mean ± SD | 7.6 ± 1.4 | 5.4 ± 1.5 | |||
| Readmission in days | No | 35 (87.5%) | 35 (87.5%) | χ2 = 0.000 | 1.000 |
| Yes | 5 (12.5%) | 5 (12.5%) | |||
| Median (min–max) | 5 (4–6) | 6 (4–7) | t = 1.443 | 0.187 | |
| Mean ± SD | 4.8 ± 0.8 | 5.8 ± 1.3 | |||
* (statistically significant)
Discussion
The introduction of new regimens in disease management in general is not an easy task especially in surgical field. The ordinary reaction involves anxiety of increased complications and rates of readmissions especially in shortened hospital stay [11]. The concept of ERP was first described by Kehlet [12] in 1999, who applied a set of standardized perioperative practices and procedures that adopted collaborative surgical and anesthetic efforts. The main target was perioperative optimization of the patient by reducing the physiological and psychological stress and reduction of hospital stay and overall cost [13]. Enhanced recovery programs were introduced in a lot of surgical specialties as orthopedics [14], gynecology [15], and several fields of general surgery [16]. The need of these protocols to be applied in colorectal surgery is highly appreciated due to its higher rates of hospital stay that may reach up to 8 days in addition to the associated higher incidence of surgical site infection up to 20%, postoperative nausea and vomiting that may reach up to 80%, and readmission rates that may reach up to 35% [17].
Laparoscopy is an integral item in ERP throughout a lot of studies [18, 19]. The application of minimally invasive techniques in addition to ERP has improved the short-term outcome after colorectal surgery [20, 21]. On the other hand, it was documented that the laparoscopic surgeon experience is an independent factor in a successful outcome and significantly less rate of conversions [22]. As the current study was a multicenter research, with a non-standardized laparoscopic learning curves, we preferred to choose the open technique to eliminate bias.
The current study showed no statistically significant difference in the socio-epidemiologic data between the two studied groups, with no impact of age and sex on the postoperative outcome. These results were contrary to Difronzo et al. [23], who described a significant difference in postoperative outcome between males and females especially old age. However, our results match with those of Petrelliet et al. [24], who did not find any impact of sex on the postoperative complications.
Thoracic epidural analgesia is one of the main components of ERP. However, in some studies, as Liu et al. [25] and Halabi et al. [26], the authors documented delay of hospital discharge by using thoracic epidural analgesia as they concluded that they may lead to hypotension and delayed ambulation with more urinary tract infection. In the current study, although the items of ERP were not studied separately, using epidural analgesia did not show a delay in the hospital discharge. There was a significantly lower hospital stay in group B than group A. On the other hand, results of Thiele et al. [27] showed that the mean hospital stay after implementation of an ERP including epidural analgesia was comparable with our results. Our rationale in supporting using of epidural analgesia is not only to utilize its benefits intraoperatively; however, it has a great role in improving postoperative course via decreasing pain severity. This was well shown in the current study as Group B patients experienced a statistically significant lower scale of pain compared to group A. Pain relief itself is an appreciated target for all patients; moreover, it will surely enhance early ambulation with consequent less pulmonary and vascular complications. The occurrence of these complications is an effective factor in delaying the discharge of the patients with less smooth postoperative recovery. Carmichael et al. [6] concluded that thoracic epidural analgesia is recommended for open but not for routine use in laparoscopic colorectal surgery, due to the observed significant decrease in postoperative pain and complications than those subjected to conventional analgesia.
Despite great advances in surgical techniques and perioperative care, postoperative ileus and distension continue to be the most common and expected events after abdominal surgery [28]. Intraperitoneal drains and nasogastric tube insertion together with enteral restriction have been used to be the traditional practice for protecting the patient from aspiration pneumonia, anastomotic leak, and wound dehiscence in a tradition of “resting the bowel until it wakes up.” However, it has been proven that these measures will not contribute to enhance the earlier return of bowel function nor protect the anastomosis to decrease the incidence of anastomotic leakage [29, 30]. Recent studies concluded that small bowel regains its motility 4–8 h postoperatively. Early oral feeding has been shown to be safely tolerated by up to 90% of patients within 24 h postoperatively and as soon as 2 h after surgery as seen in ERP after colorectal surgery [31]. These findings quite match with our results in significantly reducing PONV.
In the current study, the mean rate of readmission was 12.5% in both groups. This matches with results of other studies as Wick et al. [32] and Damle et al. [33] that were11.4% and 13.7% respectively within 30 days of discharge. Hospital readmission is considered as a quality indicator by most organizations and as a very objective reflection of the rate and severity of postoperative complications. Consequently, in the current study, ERP did not add the burden of complications to the patients within this group.
Conclusion
ERP are safe, reliable, simple, and applicable in open left side colon cancer surgery, with no negative impact on the postoperative complications in comparison with conventional care. ERP are preferable than the conventional perioperative care as regards postoperative pain and less overall hospital stay and consequently cost.
Compliance with Ethical Standards
Approval to conduct the research was obtained from institutes’ ethical and research committees.
Conflict of Interest
The authors declare that they have no conflict of interest.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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