COMPARISON OF ENHANCED RECOVERY AFTER SURGERY (ERAS) PATHWAY VS. STANDARD CARE IN PATIENTS UNDERGOING ELECTIVE STOMA REVERSAL SURGERY- A RANDOMIZED CONTROLLED TRIAL
Vikram Kate*1, Madan Shivakumar1, Sathasivam Sureshkumar1, Amaranathan Anandhi1, Gurushankari Balakrishnan1, Keerthi AR1, Palanivel Chinnakali2, Pankaj Kundra3
1Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India; 2Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India; 3Department of Anaesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India
Introduction: Up to 15-20% of patients undergoing stoma reversal surgery develop post-operative morbidity which is related to conventional practices such as prolonged pre-operative fasting, mechanical bowel preparation, delayed post-operative ambulation or resumption of orals. Enhanced Recovery After Surgery (ERAS) pathways have the potential to reduce the length of hospitalization and improve perioperative outcomes in these patients. This study was conducted to evaluate the feasibility, efficacy, and safety of ERAS protocol in patients undergoing elective stoma reversal surgery.
Methods: This was a single-centre, prospective, open-labelled, parallel arm, superiority randomized controlled trial carried out in a tertiary care hospital. Consecutive patients above 18 years of age who needed elective reversal of ileostomy or colostomy were pre-operatively randomized into standard care and ERAS care groups. Patients with American Society of Anaesthesiologists class ≥ 3, those needing laparotomy to reverse stoma, patients with cardiac, renal, neurological illnesses, bedridden patients and those on steroid medications were excluded. Eligible patients were randomly assigned in 1:1 ratio to either the standard care or ERAS care groups using a serially numbered opaque sealed envelope upon ward admission. Block randomization was done with block sizes of 4 and 6. Primary outcome was the length of hospitalization (LOH). Functional recovery parameters such as time for resolution of ileus, time to resumption of liquid, solid diet, time taken for mobilization and morbidity parameters were assessed.
Results: A total of 80 patients were recruited for the study between October 2020 and June 2022 with 40 patients each randomized into standard and ERAS care groups. The two groups were comparable in terms of demographic and clinicopathological characteristics (Table 1). Compared with standard care group, ERAS care group patients had significantly reduced LOH (5.3 ± 0.3 vs 7 ± 2.6; mean difference: 1.73 ± 0.98; p=0.0008) (Table 2). Functional recovery was earlier in ERAS care group compared to standard care group such as early resolution of ileus (median-2 days; p<0.001), time to first stool (median-3 days; p=0.0002), time to resumption of liquid diet (median-3 days; p<0.001) and solid diet (median-4 days; p<0.001) (Table 2). Surgical Site Infections (SSIs) were significantly lesser in ERAS care group (12.5% vs 32.5%; p=0.03) while post-operative nausea/vomiting (p=0.08), pulmonary complications (p=0.17) and urinary tract infections (p=0.56) were comparable in both groups.
Conclusion: ERAS pathways are feasible, safe and significantly reduces LOH in patients undergoing elective stoma reversal surgery.
Table 1.
Table 2.
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