| Background:Esophagectomy is still the standard treatment for patients with resectable esophageal cancer.However,traditional open surgery for esophageal cancer is extremely traumatic and patients need a very long time to recover and the quality of life after esophagectomy decrease dramatically.In recent 20 years,the application of minimally invasive esophagectomy(MIE)for esophageal cancer is increasing year by year.MIE could recude surgical trauma and stress compared with open surgery and patients' quality of life could be improved by MIE.Although,MIE is widely used for surgical treatment for esophageal cancer,patients' recovery after MIE still very slow and the time of hospital stay is still very long.“Nil-by-mouth” for about 1 week,nasogastric tube and enteral feeding tube are still necessary after MIE.Enhanced recovery after surgery(ERAS)has been successfully applied in the field of gastrointestinal surgery.However,the concept of ERAS has not been widely applied in the field of esophagectomy.Early oral feeding after esophagectomy is the key issue of ERAS and one of our previous studies showed that early oral feeding after esophagectomy is safe and feasible.We put forward the protocol of “non-tube no fasting” in patients with esophagectomy for cancer.Objective:To evaluate whether early oral feeding(EOF)is non-inferior in terms of postoperative cardiac,respiratory and gastrointestinal(CRG)complications after McKeown MIE for esophageal cancer compared with usual care.To compare the effect of early oral feeding on postoperative recovery,proinflammatory cytokins(interleukin-6,IL-6;interleukin-8,IL-8;tumor necrosis factor-a,TNF-?;high-mobility group box chromosomal protein 1,HMGB-1;monocyte chemotactic protein-1,MCP-1)and short-term(24 weeks after operation)quality of life(QOL).Methods:This is a randomized controlled study from Henan Cancer Hospital(ID code NCT01998230).Patients were randomly allocated to a group that started oral feeding on the first postoperative day(EOF group)or a group that remained nil by mouth until 7 days after surgery(late oral feeding,or LOF,group).The rate of postoperative complications and recovery after operation were recorded.Proinflammatory cytokines(interleukin-6,IL-6;interleukin-8,IL-8;tumor necrosis factor-a,TNF-?;high-mobility group box chromosomal protein 1,HMGB-1;monocyte chemotactic protein-1,MCP-1)changes between the two groups(25 patients in EOF group and 21 patients in LOF group)and within groups were evaluated by ELISA(enzyme linked immunosorbent assay)before operation,and at POD 1,POD 3 and POD 5.Patients' QOL was tested by EORTC questioniares before operation,and 2 weeks,4 weeks,12 weeks,and 24 weeks after operation.Results:Between February 2014 and October 2015,280 patients were included in this study,with 140 patients in the EOF group and 140 patients in the LOF group.Pneumonia is the most common complication in both groups [10.7%(15/140)in EOF group versus 12.1%(17/140)in LOF group,P = 0.707).The rate of anastomotic leakage was 3.6%(5/140)in EOF group compared with 4.3%(6/140)in LOF group,or a difference of-0.7%;95% confidence interval-5.3% to 3.9%,P = 0.758.EOF was non-inferior to usual care(LOF)for CRG complications [30.0%(n = 35)in the EOF group versus 32.9%(n = 46)in the LOF group,or a difference of-2.9%;95% confidence interval-13.8% to 8.0%].The rate of total complication was 34.3%(48/140)in EOF group compared with 38.6(56/140)in LOF group,or a difference of-4.3%;95% confidence interval-15.6% to 7.0%,P = 0.845.EOF group and LOF group exhibited similar preoperative proinflammatory cytokins(IL-6,IL-8,TNF-?,HMGB-1,MCP-1)levels.The level of all proinflammatory cytokines increased significantly at POD1 compared with preoperative level and decreased thereafter.At PODs 3 and 5,the levels of IL-6 and IL-8 in the EOF group were significantly lower than those in the LOF group(all P < 0.05).At POD 3,the levels of TNF-?,HMGB-1 and MCP-1 in the EOF group were significantly lower than those in the LOF group(all P < 0.05).The times to first flatus [2(2-3)days versus 3(2-3)days,P = 0.001],bowel movement(3(3-4)days versus 4(3-4)days,P < 0.001)and the length of postoperative stay [7(7-8)days versus 10(9-12)days,P < 0.001] were significantly shorter in the EOF group compared with the LOF group.No statistical differences were found in baseline QOL scores between the two groups.QOL declined markedly in all patients at 2 weeks postoperatively,thereafter QOL gradually returned toward baseline within the first half year.Two weeks after the operation,patients in the EOF group reported higher global QOL(P = 0.002),physical functioning scores(P = 0.017),emotional functioning scores(P < 0.001)and social functioning scores(P < 0.001).Two weeks after the operation,patients in the EOF group reported lower scores of fatigue(P < 0.001),nausea and vomiting(P < 0.001),pain(P < 0.001),diarrhea(P < 0.001),dysphagia(P < 0.001),eating(P < 0.001)and trouble swallowing saliva(P < 0.001)than patients in the LOF group.Four weeks after the operation,patients in the EOF group reported higher global QOL(P < 0.01)and lower diarrhea(P=0.037),nausea and vomiting scores(P = 0.002)than patients in the LOF group.Conclusion:EOF in patients with McKeown MIE is non-inferior to usual care with regard to postoperative CRG complications,in addition to hastening bowel function recovery and shortening postoperative stay.Compared to conventional rehabilitation program,EOF could decrease proinflammatory cytokines and improve the short term QOL after McKeown minimally invasive esophagectomy. |
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