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COMPARISON OF ADAPTED ENHANCED RECOVERY AFTER SURGERY PATHWAY VERSUS STANDARD CARE FOLLOWING SIMPLE CLOSURE OF PERFORATED DUODENAL ULCER-A RANDOMIZED CONTROLLED TRIAL
Mohsina Subair*1, Vikram Kate1, Shanmugam Dasarathan1, Sathasivam Sureshkumar1, T Mahalakshmy2, Pankaj Kundra3
1general surgery, JIPMER, Pondicherry, pondicherry, India; 2Department of preventive and social medicine, JIPMER, Pondicherry, pondicherry, India; 3Department of Anaesthesia and critical care, JIPMER, Pondicherry, pondicherry, India
Introduction: The Enhanced Recovery after Surgery (ERAS) pathways although widely used in elective procedures, its role in emergency setting remains uncertain; with only two published reports. The ERAS programme is often modified in elective procedures on an institutional basis and thus may have a role in emergency setting albeit in modified form. Hence, this study was carried out to investigate the feasibility and efficacy of adapted ERAS pathways in an emergent setting in patients undergoing simple closure for perforated duodenal ulcer.
Methodology: This was a single-center, prospective, open labeled, parallel arm, superiority, randomized controlled trial carried out in a tertiary care hospital between September 2014 and May 2016. Patients with perforated duodenal ulcer undergoing open simple closure were assessed for eligibility and randomly assigned in 1:1 ratio into the standard care group and adapted ERAS group. Patients with refractory shock, ASA class≥3, perforation of size≥1cm and having any concomitant definitive surgery were excluded. The adapted ERAS pathway was designed based on the components of the ERAS which could be applied in an emergency setting and aimed at multimodal opioid sparing analgesia, prevention of ileus, early enteral nutrition, early removal of tubes and early mobilization. A sample size of 50 in each group was calculated (effect size: reduction in LOH by 2 days; power: 90%). The primary outcome was the length of hospital stay (LOH). The secondary outcomes were time for first flatus, first defecation, time of withdrawal of tubes and time of starting liquid/solid diet, morbidity (post-operative complications) and mortality.
Results: A total of 102 patients were included in the study, 52 in the standard care group and 50 in the adapted ERAS group respectively. Among the 52 patients, three patients (ileal perforation, DU perforation≥1cm, sealed perforation) were excluded from the study after randomization. All the demographic and clinicopathological characteristics were comparable including age, gender, ASA class, duration of illness, size of perforation and Mannheim Peritonitis Index. Patients in adapted ERAS pathway group had a significantly early recovery of bowel functions, removal of tubes and drains and mobilization when compared with the standard care group (Table 1). The length of hospitalization in ERAS group was significantly shorter than the standard care group (5.36 ±1.39 vs. 9.78± 4.30 days; p<0.001, CI 3.14-5.68). Post-operative complications were significantly reduced in the ERAS group (Table 2); however, the leak rates from the omentopexy site were similar (1/50 vs. 2/49).
Conclusion: ERAS pathways, in a modified form are safe, tolerable and feasible for application in select patients undergoing simple closure of perforated duodenal ulcer without an increase in the rate of complications.
Composite table showing the important primary and secondary outcomes between the patients in adapted ERAS and standard perioperative care groups
| Outcome variable | Adapted ERAS group | Standard perioperative care group | Mean difference | p value | CI |
| Mean length of hospitalization(in days) | 5.36±1.39 | 9.78± 4.30 | 4.41± 0.64 | p<0.0001* | 3.14 to 5.68 |
| Mean day of withdrawal of nasogastric tube(days) | 1.22±0.42 | 3.37±0.97 | 2.15±0.15 | p<0.001* | 1.85 to 2.45 |
| Mean time to first bowel sound(in days) | 1.46±0.542 | 2.02±0.595 | 0.560±0.114 | p<0.001* | 0.33 to 0.79 |
| Mean time to first flatus(in days) | 2.0±0.782 | 3.47±1.023 | 1.47±0.183 | p<0.001* | 1.107 to 1.832 |
| Mean time to first stool(in days) | 3.52±0.79 | 5.78±1.26 | 2.27 ±0.21 | p<0.001* | 1.84 to 2.67 |
| Mean duration of ileus(in days) | 1.4 ± 0.07 | 2.02 ± 0.09 | 0.620 ± 0.126 | p<0.001* | 0.38 to 0.86 |
| Mean time to first fluid diet(in days) | 1.52±0.76 | 4.24 ±2.64 | 2.72± 0.39 | p<0.001* | 1.95 to 3.50 |
| Mean time to first solid diet(in days) | 2.64±1.08 | 4.24±2.64 | 3.71 ±0.45 | p<0.001* | 2.82 to 4.60 |
| Mean time of removal of urinary catheter(days) | 1.04 ± 0.20 | 1.49± 0.77 | 0.450±0.11 | p<0.001* | 0.23 to 0.67 |
| Mean time of removal of drain(in days) | 1.38±1.09 | 5.04 ±2.12 | 3.66± 0.35 | p<0.001* | 2.96 to 4.36 |
| Need for extra analgesia | 6(12%) | 17(35%) | 0.26 | 0.007** | 0.09 to 0.69 |
| Need for NG tube re-insertion | 2(4%) | 3(6%) | 0.63(OR) | p=0.629** | 0.11 to 3.25 |
*unpaired t test, ** Chi- square test
Comparison of post-operative complications between patients in adapted ERAS and standard perioperative care groups
| Complication | Adapted ERAS Group
n=50(%)
| Conventional Group
n=49(%)
| Relative risk | P value* | Confidence interval |
| Number of patients who developed PONV | 9(18) | 31(63) | 0.28 | <0.0001 | 0.15 to 0.51 |
| Superficial SSI# | 5(10) | 14(29) | 0.35 | 0.02 | 0.14 to 0.85 |
Organ space SSI#
With leakage
| 1(2) | 2(4) | 0.49 | 0.54 | 0.07 to 3.63 |
Pulmonary
Complications
| 2(4) | 8(16)## | 0.24 | 0.04 | 0.06 to 0.95 |
| Urinary tract infections | 1(2) | 9(18) | 0.11 | 0.007 | 0.018 to 0.62 |
*Chi-square test
#SSI- surgical site infection
None of the patients had organ space SSI without leak
##All patients had basal atelectasis
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