Ijs_july_aug_05.pmd

Safety of early oral feeding aftergastrointestinal anastomosis: a randomizedclinical trial Department of Surgery, Baqiyatallah University of Medical Sciences, 1Azad-Tehran University of Medical Sciences, Tehran, Iran For correspondence:SA Fanaie, Department of Endoscopic Surgery, 13th Floor, Milad Hospital, Hemat Highway, Tehran, IR, Iran.
E-mail: [email protected] Background: Different abdominal surgeries could benefit from early feeding. Aims: To compare earlyfeeding with traditional postoperative dietary management for development of postoperativegastrointestinal (GI) symptoms. Settings and Design: A prospective randomized controlled study. Methodsand Materials: This was a study of 110 patients who were randomly allocated to early feeding beginningwith liquid diet, 8 h postoperatively; whereas those in the traditional feeding group were given aregular diet with normal bowel sounds. Statistical analysis used: Fisher exact test, P value less than0.05 was significant. Results: There were no differences in patients’ demographics, surgical procedure,and anesthesia used. Complete data were available for 110 patients; 55 were allocated to the early Original Article
feeding group and 55 to the late feeding group. The incidence of postoperative ileus did not differbetween the two groups [early 1 (1%) vs late (1) 1%, P > 0.05 NS]. However, there was no significantdifference in the rate of intraoperative complication such as, leakage of anastomosis, mesentericembolus, wound infection, and wound dehiscence between groups [7.2% (4) vs 16.36% (9), respectively,P value = 0.093 NS]. Also, there were no significant differences in mortality between the two groups.
Conclusion: Early feeding in GI anastomosis seems to be safe, well tolerated, and was not associatedwith increased postoperative GI complaints including ileus and postoperative complications such aswound dehiscence, infection, leakage, anastomosis, and mortality.
Key words: Early feeding, Gastrointestinal anastomosis How to cite this article:Ahamd FS, Ali ZS. Safety of early oral feeding after gastrointestinal anastomosis: a randomized clinical trial. Indian J Surg 2005;67:185-8.
examined its use after gastrointestinal (GI) anastomo-sis. A randomized controlled trail that compared an Traditionally, after abdominal surgery, the pas- early regular diet to conventional postoperative die- sage of flatus, or bowel movement was the clin- tary management to determine GI complications and ical evidence for starting an oral diet. The res- mortality after major GI anastomosis was conducted.
olution of postoperative ileus defined by the The secondary purpose of this trial was to evaluate passage of flatus usually occurred within the incidence of postoperative ileus after major GI anas- 5 days.[1] Studies were undertaken to evalu- tomosis with early feeding in comparison with con- ate whether different abdominal surgeries could benefit from early feeding. Early feed-ing improves the outcome of patients with trauma and burns,[2] although few studies have Between August 2003 and November 2004, after the Paper Received: May 2005. Paper Accepted: July 2005. Source
study was approved by the Human Research Review of Support: Nil.
Committee, patients at the referral hospital who had Indian J Surg | August 2005 | Volume 67 | Issue 4 Free full text available from http://www.indianjsurg.com GI anastomosis were offered participation, and those starting the diet, was performed after the first postop- who agreed gave informed consent. Patients with his- erative day in the early feeding group. Postoperative tories of acute obstruction, perforation, intra-abdomi- ileus was managed by IV Hydration, no oral intake nal infection and who were aged lesser than 16 years antiemetic, and radiological evaluation of the abdo- were excluded. All patients underwent general an- men. If vomiting was unresponsive to antiemetic, a esthesia. However, epidural catheter was not used for nasogastric tube was placed and removed after symp- pain relief postoperatively. Only those patients who toms resolved. On the day of discharge, they answered had laparoscopic procedures were not included be- questions about nausea, vomiting, cramping, disten- cause they were discharged from the recovery room tion, desire for oral feeding, and first day of flatus pas- sage or bowel movement. A power analysis was donebased on an average incidence of postoperative ileus After completion of surgery, surgeons called a research reported in the literature of approximately 25%,[8] with physician who assigned patients to early or late feed- a doubling of that rate considered clinically signifi- ing groups using a random number table with pseudo cant. With 80% power and a = 0.05, 110 patients were randomization and disguised block length of five with needed to show a twofold greater incidence of postop- 1 : 1 ratio. Surgeons were not masked to feeding erative ileus in the early feeding group.
groups after surgery. Patients in the early feeding groupwere offered simply a liquid diet within 6 h of arrival Fisher exact test was used to analyze discrete varia- on the ward. If they tolerated 1 liter within 24 h, they bles such as postoperative ileus. Continuous variables were started on free liquid on the second day, and reg- were analyzed using student’s t-test.
ular diet on the third day. In both groups, the nasogas-tric tube was removed immediately after surgery. Pa- tients with normal postoperative course were dis-charged when they could tolerate a regular diet. In our Between August 2003 and November 2004, 110 pa- study, we did not compare the length of hospital stay tients who had major abdominal surgery for anasto- to evaluate all postoperative complications equally in mosis indications agreed to participate. Complete data both groups. Demographic information collected in- were available for 110 patients, with 55 (31men and cluded the age, sex, medical, and surgical histories of 24 women) patients with 66.45 mean years old to ear- the patients and indications for anastomosis. The sub- ly feeding, and 55 (38 men, 17 women) with 63.44 jects had different types of major anastomosis and were mean years old to late feeding. No patient was exclud- randomly allocated to feeding groups irrespective of ed. There were no significant demographic differenc- anastomotic type to eliminate bias [Table 1]. The length es between groups, including age, medical, and surgi- of time until bowel movement was first passed was also noted. Given the common clinical practice ofmorning and evening patient assessment, bowel func- Indications for anastomosis approximately were simi- tion variables, including normal bowel sounds and lar between groups [Table 1], with biliary tract anasto- passage of flatus and bowel movement, were treated mosis common in the early feeding group [14.54% (8) as ordinal not continuous variables and recorded as vs 12.72% (7), P > 0.05] and small intestine anasto- occurring on a specific postoperative day. Patients were mosis was common in traditional feeding [20% (11) vs not given oral or rectal bowel stimulants after surgery.
16.36% (9), P > 0.05]. General endo tracheal anesthe- Whether early oral feeding increased the postopera- sia was used in all cases. Preoperative complications tive complications or was it safe and well tolerated did not differ between the groups. Interestingly, post- was not very clear. In the early feeding group, the rate operative complications did not differ significantly of postoperative complications, even ileus did not dif- between the groups [Table 2]. However, the incidence fer from the conventional diet. The main outcome was of postoperative ileus did not differ between the groups to evaluate postoperative complications that included (one patient in the early feeding group and one pa- wound infection, leakage of anastomosis, obstruction, tient in the traditional group, P value = 0.8 NS).
mesenteric emboli, upper GI bleeding, wound dehis- Among the 110 participants, the overall incidence of cence, prolonged ileus, and mortality. Ileus was de- complication was 9.09% for the early feeding group fined as hypoactive bowel sounds, abdominal disten- and 16.36 for the traditional feeding group.
tion, and no passage of flatus or bowel movement withor without nausea or vomiting after the first postoper- Most patients had active bowel sounds on the day of surgery or the first postoperative day, flatus by the firstor second postoperative day, and bowel movement by The patients had to meet all the criteria in both groups the second or third postoperative day. The mean ± standard deviation postoperative day whennormal bowel sounds are auscultated (0.5 ± 0.6 vs 0.5 Same as other studies,[4]–[7] evaluating the ileus, after ± 0.5 days, P = 0.65), flatus was passed (1.7±0.7 vs Indian J Surg | August 2005 | Volume 67 | Issue 4 Early oral feeding gastrointestinal anastomosis: RCT 1.6 ± 0.8 days, P = 0.7), and first bowel movement showed bowel activity before flatus was passed, which reported (3.9 ± 0.7 vs 4.46 ± 1.2 days, P = 0.07), illustrates that patients tolerate fluid secretions of 1– early vs late feeding groups, respectively. The subjects 2 l from the stomach and pancreas immediately after received similar amounts of pain medication, includ- surgery. Studies also have shown tolerance to clear liq- ing oral ibuprofen (2427 ± 1665 vs 2535 ± 1737 mg, uids on postoperative day 1 after GI surgeries.[15],[16],[18] P = 0.77) early vs late feeding group, respectively.
Marik and Zaloga conducted meta-analysis of prospec- When data were stratified within feeding groups to tive, randomized studies comparing early vs late en- compare type of anastomosis, no significant differenc- teral feeding demonstrating the benefits of early nutri- es in any of the outcomes were noted including post- tion.[4] However, the preferred feeding site for enteral nutrition remains controversial.[5] Despite this fact,Seenu and Goel[6] showed that early oral feeding after elective colorectal surgery is safe and can be toleratedby most patients. Similarly,[7] Difronzo et al.[12] demon- The key finding in our study was that postoperative strated a high tolerability (86.5%) to early postopera- complications did not differ significantly between the tive oral feeding after elective open colon resection.
two groups [Table 2]. Similarly, oral feeding was toler- These studies were not exclusive to colorectal surgery.
ated with low morbidity following small or large bow- Suehiro et al.[19] showed that early oral feeding after el resections[9] and not associated with the occurrence gastrectomy is safe and the incidence of complications of anastomotic dehiscence.[10] However, patients un- including anastomosis leak and wound infection oc- dergoing elective colorectal resection can be managed curred equally in both groups. Our study documents a without postoperative NG catheter, starting oral feed- further advance in postoperative treatment of patients ing on the first postoperative day.[11] Interestingly, in who have major abdominal anastomosis. It was found older patients undergoing elective open-colon resec- that by offering liquid 6 h after surgery, increased in- tion, early feeding results in a short hospital stay and cidence of ileus, rather than following a rigid proto- low postoperative morbidity. The results are compara- col. That finding is supported by Resnick et al.’s re- ble to those reported for laparoscopy-assisted colecto- view of postoperative ileus and documentation of nor- my.[12] Some review literatures support safety of early mal bowel physiology.[20] Also, there were no differ- ences in postoperative complications, including,wound infection, wound dehiscence, leakage of anas- The secondary outcome of our study was the incidence tomosis, mesenteric embolus, obstruction, upper GI of postoperative ileus in early feeding groups that was similar to conventional diet. Postoperative ileus doesnot have a standard definition. Livingston and Passa- Nausea and vomiting, however, occur more common- ro[3] define ileus as the functional inhibition of pro- ly after upper GI surgery than after resection of the pulsive bowel activity, irrespective of the pathologic small intestine and colon. However, there is no evi- mechanism. The exact etiology of ileus is unknown, dence that bowel rest and a period of starvation are but it is believed to be more common after laparotomy beneficial for healing of wounds and anastomotic in- and procedures that enter the peritoneal cavity.[3] Many factors are believed to contribute to it, including in-traoperative, bowel manipulation, anesthetic agent, In our clinical experiment, there were no differences peri operation narcotics, and postoperative sympathet- ic hyperactivity.[3],[15] Postoperative ileus can result inaccumulation of gas and secretions leading to disten- It is therefore concluded that early feeding is safe and tion, emesis, pain, and longer hospital stay. Currently well tolerated by patients undergoing bowel resection.
available therapies are supportive and include intra- In addition, it is not associated with increased postop- venous hydration and nasogastric suctioning.[3] Tradi- erative GI complications including postoperative com- tion dictates advancement of postoperative diet based on physical signs of bowel function and not on post-operative GI physiology. Animal and human radiolog- ical and physiologic studies do not support the tradi-tional practice of oral feeding based on auscultation of Nicholas J Petrelli, Charles Cheng, Deborah Driscoll. Early Postoperative Oral Feeding After Colectomy; An Analysis of Factors normal bowel sound and passage of flatus and bowel That May Predict Failure. Annals of Surgical Oncology movement.[3],[15],[16] After surgery, return of bowel func- tion and motility usually occurs within 6–12 h in the Cornelia S Carr, Eddie L, Paul Boulos. Randomized trial of small bowel, 12–24 h in the stomach, and 48–72 h in safety and efficacy of immediate postoperative enteral feeding the colon.[17] Physiologic studies have found that myo- in patients undergoing gastrointestinal resection. BMJ1996;312:869-71.
electric and motor activity in the stomach is not af- Livingston EH, Passaro EP Jr, Postoperative ileus. Digest Dis fected after abdominal surgery.[15] Schilder et al.[16] Indian J Surg | August 2005 | Volume 67 | Issue 4 Marik PE, Zaloga G. Early enteral nutrition in acutely ill a clinical review. Obstet Gynecol Surv 2000;55:571-3.
patients: a systematic review. Crit care Med 2001;29:2264-70.
14. Bisgaard T, Kehlet H. Early oral feeding after elective abdominal Toulson DC,Maria I da silva, Rodrigo G. The impact of early surgery- what are the issues? Nutrition 2002;18: 944-8.
nutrition on metabolic response and postoperative ileus.
15. Bufo AJ, Feldman S, Daniels GA, Lieberman RC. Early Current Opinion in Clinical Nutrition & Metabolic Care postoperative feeding. Dis Colon Rectum 1994;37:1260-5.
16. Schilder JM, Hurteau JA, Look KY, Moore DH, Raff G, Stehman Seenu V, Goel Ak. Early feeding after elective colorectal FB, et al. A prospective controlled trial of early postoperative surgery: is it safe. Trop Gastroenterol 1995;16:72-3.
oral intake following major abdominal gynecologic surgery.
Petrelli NJ, Cheng C, Driscoll D, Rodriguez-Bigas MA. Early postoperative oral feeding after colectomy: an analysis of 17. Finan MA, Barton DP, Fiorica JV, Hoffman MS, Roberts WS, factors that may predict failure. Ann Surg Oncol 2001; 8:796- Gleeson N, et al. Ileus following gynecology surgery. South Burrows WR, Gingo AJ Jr, Rose SM, Zwick SI, Kosty DL, Dierker 18. Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras IJ, LJ, et al. Safety and efficacy of early postoperative solid food Wexner SD. Is early oral feeding is safe after elective colorectal consumption after cesarian section. J Reported Med surgery? A Prospective randomized trial. Ann Surg 1995; Bohm B, Haase O, Hofmann H, Heine G, Junghans T, Muller 19. Suehiro T, Matasumata T, Shikada Y, Sugimachi K. Accelerated JM. Tolerance of early oral feeding after operation of the lower rehabilitation with early postoperative oral feeding following gastrointestinal tract Chirurg 2000;71:955-62.
10. De Aguilar-Nascimento JE, Goelzer J. Early feeding after 20. Resnick J, Greenwald DA, Brandt LJ. Dealayed gastric emptying intestinal anastomosis: risks or benefits? Rev Assoc Med Bras and postoperative ileus after nongastric abdominal surgery: Part 1. AM J Gastroentrol 1997;92:751-62.
11. Feo CV, Romanini B, Sortini D, Ragazzi R, Zamboni P, Pancini 21. Schroeder D, Gillanders L, Mahr K, Hill GL. Effects of GC, et al. Early oral feeding after colorectal resection: a immediate postoperative enteral nutrition on body randomized controlled trial. ANZ J Surg 2004;74:296-7.
composition, muscle function and wound healing. J Parenter 12. Difronzo LA, Yamin N, Patel K, O’Connel TX. Benefits of early feeding and early hospital discharge in elderly patients undergoing 22. Haydock DA, Hill GA. Impaired wound healing in patients open colon resection. J Am Coll Surg 2003;197:747-52.
with varying degree of malnutrition. J Parenter Enteral Nutr 13. Johnson Casto C, Krammer J, Drake J. Postoperative feeding : Indian J Surg | August 2005 | Volume 67 | Issue 4

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Running a Kaplan-Meier analysis with XLSTAT-Life Dataset to run a Kaplan-Meier analysis An Excel sheet with both the data and results can be downloaded by clicking The data have been obtained in [Gehan E.A. (1965). A generalized Wilcoxon test for comparing arbitrarily singly-censored samples. Biometrika, 52, pp 203—223] and represent a randomized clinical trial investigating the effe

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