Preliminary Report on Introduction of Enhanced Recovery After Surgery Protocol for Laparoscopic Rectal Resection: A Single-Center Experience

Introduction

The mainstay treatment for rectal cancer remains surgical resection, for which outcomes have markedly improved over the last 20 years, owing mostly to the introduction of total mesorectal excision. ¹ Radiotherapy and chemotherapy also have major roles in the management of locally advanced rectal cancer. ² Although met initially with skepticism, the laparoscopic approach to rectal cancer has gained popularity, and now is a widespread technique, performed by more than 70% of experienced colorectal surgeons worldwide, and more than 80% in the United States. ³ Since the 1990s, when Kehlet and colleagues ⁴ introduced fast track (FT) surgery, several prospective randomized trials and comprehensive reviews have shown advantages in the application of FT surgery in terms of reducing hospital stay, surgical stress, and perioperative morbidity.^5–9 The enhanced recovery after surgery (ERAS) protocol for laparoscopic colorectal surgery has been shown in different studies to facilitate postoperative recovery of patients.^10–12

Only in the last few years, ERAS has been introduced for rectal cancer patients, and to date, there is a relative paucity of data regarding the role of laparoscopy combined with an enhanced recovery rehabilitation program.^13–16 In light of these facts, we postulated that application of ERAS protocol for laparoscopic rectal resection (LRR) for cancer would potentially reduce length of stay (LOS) without increasing perioperative morbidity and readmission rate in our patients. To explore this hypothesis, we retrospectively analyzed our approach to patients affected with rectal cancer and treated with laparoscopic surgery before and after implementation of the ERAS protocol at our institute. Primary endpoints considered in this retrospective evaluation were hospital LOS, rate of complications, and readmission.

Materials and Methods

From 2005 to 2016, we performed 761 colorectal resections. Fifty-six percent (56%) of cases were performed with a laparoscopic approach, with a progressive increase in this percentage from 35% of cases in 2005 to 89% of cases in 2016. We included in our evaluation 150 patients who underwent surgery for rectal cancer from January 2009 to December 2016.

The ERAS protocol for colorectal surgery was introduced at our institute in January 2013 in two steps: first as FT surgery protocol, while in June 2016, a second step pushed toward implementing ERAS society guidelines. ¹⁷ A multidisciplinary team of anesthesiologists, surgeons, nurses, and physical and respiratory therapists followed the application of FT and ERAS protocols. Pathways of FT, ERAS, and conventional protocols are summarized in Table 1.

Patients treated with LRR from January 2009 to December 2012 formed our control group. Patients with synchronous lesions were excluded from evaluation. All our patients received preoperative clinical evaluation, tested serologic markers, chest and abdominal computed tomography (CT) scan, endoscopic rectoanal ultrasound, and colonoscopy during which tumor distance from anal verge was measured. Patients with T2 N0 or T3, T4, and N+ stage were enrolled for neoadjuvant chemoradiotherapy protocol (capecitabine +4500 GY), restaged with chest and abdomen CT scan, EUS, and, after a minimum period of 6 weeks, underwent surgery.

Ultra short-term antibiotic prophylaxis was administered preoperatively. Low-molecular-weight heparin for prophylaxis of thromboembolism was started on postoperative day 1. All surgeries were performed by three surgeons with experience in both open and laparoscopic colorectal surgery.

To briefly describe our technique, we start our cases with the patient positioned in lithotomy position. After pneumoperitoneum achievement, a 30° 10-mm laparoscope is inserted through a 12-mm trocar in the right iliac fossa, followed by two additional 12-mm trocars placed in periumbilical position and just above pubic symphysis. A fourth 5-mm trocar is inserted in the left flank, as per surgeon's choice. With the patient in Trendelenburg position, the pelvic peritoneum is opened below the sacral promontory, proceeding toward the duodenojejunal angle of Treitz, and once the left ureter is identified and preserved, the inferior mesenteric artery is isolated and resected at 1 cm from the origin to preserve the hypogastric nerve. The inferior mesenteric vein is then resected. In all cases, mobilization of the left colic flexure dividing the splenocolic and phrenocolic attachments is accomplished. Rectal dissection is started with a circumferential peritoneal incision. With sharp maneuvers, the posterior wall of the mesorectum is completely detached behind the branches of superior hypogastric nerves down to the elevator muscles.

Total mesorectal excision is then continued with the aim of preserving the pelvic autonomic plexus. Successively, the rectum is sectioned. For cancers located above the distal mesorectal margin, section is performed at a minimum of 2 cm from the neoplasm, while for cancers located below the distal mesorectal margin, it is done with the aim of 1-cm negative distal margin. A double-stapled Knight-Griffen transanal anastomosis is performed with a proximate ILS^® (Ethicon Endosurgery) circular stapler. In all cases in which the tumor is located less than 8 cm from the anal verge, a temporary ileostomy is performed and, after 1 month, as per protocol, closed. In all cases of low rectal cancer, in which after resection at extemporary histologic evaluation the distal margins are positive for neoplasm, an abdominoperineal amputation of the rectum is done.

For all patients, the following preoperative parameters were recorded: age, gender, body mass index, American Society of Anesthesiologists (ASA) classification, preoperative surgery, distance of neoplasm from anal verge, and neoadjuvant chemoradiotherapy. The following operative variables were registered: type of intervention, duration of surgery, conversions to open surgery, hand-assisted and full laparoscopic surgery, and diverting ileostomy. Pathology reports were reviewed to assess lesion histology and lymph node involvement. The type of complications according to the Clavien-Dindo classification was recorded. Patients were discharged home after passing gas or stools, and recovery of ability to move and eat properly. Cause and number of readmissions were recorded.

Results

There were 150 patients included in the study, 94 in the ERAS group (74 FT protocol and 20 ERAS protocol), and 56 in the control group. No significant differences were found in preoperative conditions, demographic variables, and tumor location (Table 2). Concerning intraoperative variables, longer operative time (P ≤ .01), more abdominoperineal amputations (P = .05), and a major use of hand-assisted technique were observed in the control group, while conversion rates were similar in both groups (Table 3). There were no significant differences in postoperative pathological tumor, lymph node, metastasis (TNM) staging (Table 4). Adherence to FT and then ERAS protocol were different (Table 5). Particularly for postoperative items, we obtained better results after implementation of ERAS protocol in June 2016.

The mean (range) LOS was 8.5 (3–32) days for patients in the ERAS group versus 10 (4–27) days for patients in the control group (P = .0823). Actually, in the ERAS group, mean LOS during first period with FT protocol application was of 9.2 days. In the following period, when we applied the definitive ERAS protocol, mean LOS was of 6 days. No evidence of different rates (P = .227) of complications was found between the two groups (Table 6). Postoperative ileus occurred in 7 (7.4%) patients in the ERAS group versus 2 (3.5%) in the control group (P = .227). One patient in the control group died on the seventh postoperative day after a cardiac arrest, although there was no 30-day mortality in the ERAS group. The reoperation rate was 8.9% in the control group and 9.4% in the ERAS group. Four patients in the control group underwent reintervention to manage anastomotic leak, while in the ERAS group, 5 patients underwent surgery for management of anastomotic leak, while in 3 cases, partial dehiscence of anastomosis was treated endoscopically with endosponge placement. In the control group, 1 patient was reoperated for intestinal obstruction, and in the ERAS group, 1 patient underwent reoperation for hemorrhage. One patient in each group was readmitted: in the control group for intestinal obstruction and in the ERAS group for anastomotic leak. Both patients underwent reoperation.

Discussion

Evaluating preliminary results of application of FT and ERAS protocols to our patients treated with LRR for cancer, we observed an initial trend to reduction in LOS in the ERAS group. These initial data confirm results reported in other studies^18,19 in the literature, but mean LOS of our patients in the ERAS group remains high compared with other reports.^16,18,20

Actually, reduction in mean LOS became significant with transition from FT to ERAS protocol. The reasons for further improvement are likely to be found in the improved adherence to pathways, which in the first years of application was missing. We started the application of FT protocol to assess the feasibility of its introduction in clinical practice in our institution. In this initial period, adherence to the new protocol was not satisfactory, but after achieving positive results, in 2016, during implementation of ERAS protocol, several steps allowed this practice to gradually shift to the status of standard of care. Indeed, we extended its application also to patients who undergo complex abdominal surgery and living kidney donation. In this second period, all patients were prospectively inserted in a database and a team of two physicians and two nurses evaluating adherence to the protocol was created. Furthermore, we have expanded the multidisciplinary team, and involved all physicians, nurses, and therapists in the abdominal surgery unit, with dedicated inservices and periodic audits to discuss and refine the protocol.

These results confirm the importance of adherence to ERAS protocol as reported by other authors,^19,21 which show a decrease in postoperative morbidity with increase in compliance to the protocol, and furthermore highlight utility of internal audits to ameliorate the protocol in each item.

Moreover, we experienced in some cases a longer LOS due to absence of rehabilitation facilities. This evidence is in line with experience reported by other authors in Italy, ¹⁹ where these facilities are often not available.

Comparing present series, intraoperative differences were registered in terms of reduction in time of surgery, reduction of cases performed with hand-assisted technique, and reduction in the number of abdominoperineal amputations in the ERAS group. These differences and particularly increase of anal sphincter sparing cases could be explained by improved skills of surgeons involved in these cases over the time period. Moreover, these changes did not impact in terms of percentage of complications in the two groups, in line with other experiences in which laparoscopic rectal cancer resections were often undertaken after laparoscopic experience was already gained in colon cancer, ²² as experienced by our surgeons.

There was no significant difference in complication rates between the two groups, in terms of severity according to the Clavien-Dindo classification and overall number of complications. This is consonant with results reported by other groups^19,21,23 and reinforces our initial hypothesis of a potential reduction of LOS without increase in postoperative morbidity. These evidences are different from those of other authors, stating that the postoperative morbidity might become a significant obstacle for the application of ERAS program to rectal cancer surgery.^15,20 No evidence of increased incidence of postoperative ileus in the ERAS group was found, as differently reported in other experiences, ²¹ even if in these patients nasogastric tube was removed immediately after surgery and diet was started the day of surgery or on first postoperative day. Our data showed no differences in readmission rate between the two groups. This evidence is in line with other^19,24 supporting efficacy of ERAS protocol since readmission is considered a marker of poor quality of care.^21,24–26

This study has some limitations related to its retrospective design, small number of patients evaluated, and modifications in the pathways of treatment in ERAS group patients. Nevertheless, it is one of a small number of studies reporting on ERAS and laparoscopic rectal surgery. For sure, randomized trials are needed to standardize ERAS in laparoscopic rectal surgery, but its implementation should become a standard of care.

Conclusions

In conclusion, our preliminary data on introduction of ERAS protocol in the management of patients who have been submitted to laparoscopic resection for rectal cancer match with the initial hypothesis, showing a trend to reduction in LOS in the ERAS group without evidence of increase in morbidity or readmission rate compared to control group treated with traditional care.