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Obstetrics & Gynecology 2002;100:230-234
© 2002 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

A Randomized Controlled Trial of a Regular Diet as the First Meal in Gynecologic Oncology Patients Undergoing Intraabdominal Surgery

Michael L. Pearl, MD, Martina Frandina, MD, Linda Mahler, RN, NP, Fidel A. Valea, MD, Paul A. DiSilvestro, MD and Eva Chalas, MD

From the Division of Gynecologic Oncology, Departments of Obstetrics, Gynecology and Reproductive Medicine, and Surgery, State University of New York at Stony Brook, Stony Brook, New York.

Address reprint requests to: Michael L. Pearl, MD, Long Island Gynecologic Oncologists, P.C., 994 Jericho Turnpike, Smithtown, NY 11787; E-mail: mlpearl{at}notes.cc.sunysb.edu.


    ABSTRACT
 TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE: To prospectively evaluate the safety and efficacy of a regular diet as the first meal after intraabdominal surgery in gynecologic oncology patients.

METHODS: During a 20-month period, 254 gynecologic oncology patients undergoing intraabdominal surgery were enrolled in a randomized controlled trial of a clear liquid diet compared with a regular diet as the first postoperative meal. All patients received their first meal on the first postoperative day in the absence of nausea, vomiting, or symptomatic abdominal distension. Standard criteria for discharge were used for all study patients.

RESULTS: The clear liquid and the regular diet groups were similar in age, disease, surgical procedure distribution, surgery length, and estimated blood loss. The incidence of nausea, vomiting, abdominal distention, frequency and duration of nasogastric tube use, passage of flatus before discharge, and percentage of patients who tolerated their diets on the first attempt were comparable for both groups. For those patients who were intolerant of the first attempt at either a clear liquid or regular diet, the time to tolerance was comparable for both groups. The time to development of bowel sounds, passage of flatus, and hospital stay were comparable for both groups. Febrile morbidity, pneumonia, wound complications, and atelectasis occurred equally in both groups. There were no known anastamotic complications or aspirations in either group. Postoperative changes in hematologic indices and electrolytes were comparable in both groups.

CONCLUSION: A regular diet as the first meal after intraabdominal surgery in gynecologic oncology patients is safe and efficacious.

Many patients with gynecologic malignancies undergo extensive intraabdominal surgery, either primarily for tumor staging and debulking or secondarily for treatment of complications related to prior therapy. Traditionally, gynecologic oncologists utilized a nasogastric tube to decompress the stomach postoperatively and withheld oral feeding until resolution of the postoperative ileus.1 Because it was believed that patients were unable to tolerate early oral feeding, the administration of postoperative pain medication was limited to parenteral routes. Once bowel function returned, oral intake was reinstituted using a clear liquid diet as the standard first postoperative meal. However, our previous studies of postoperative dietary management found that routine use of postoperative nasogastric tube decompression is not necessary and that early institution of a clear liquid diet and oral pain medication is safe and efficacious in this patient population.2–4

Recently, the need to withhold a regular diet has been questioned. Two trials utilizing patients who had gastrointestinal or intraabdominal procedures did not find increased morbidity associated with early initiation of a regular diet.5,6 Furthermore, nutritional analysis revealed a higher caloric intake in patients receiving a regular diet.6 However, those trials primarily evaluated patients who had isolated bowel surgery, many of whom did not have a malignancy. Thus, the results of these trials might not apply to gynecologic oncology patients, most of whom undergo multiple procedures during surgery.

This prospective, randomized, controlled trial was undertaken to evaluate the safety and efficacy of a regular diet as the first meal after intraabdominal surgery in gynecologic oncology patients.


    PATIENTS AND METHODS
 TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
This trial was approved by the Institutional Review Boards at the State University of New York at Stony Brook, and informed consent was obtained from all patients. All gynecologic oncology patients who had nonlaparoscopic intraabdominal surgery were eligible. After induction of general anesthesia, patients were randomized by a computer-generated random number list. All patients had an orogastric tube placed intraoperatively and removed at the completion of surgery.

All surgical procedures were performed by the authors or by residents under the authors’ direct supervision. The anesthetic, recovery room, postoperative pain, and antiemetic treatment of the study patients were standardized and recorded.2–4 A variety of demographic and clinical indices were recorded.

Patients allocated to a clear liquid diet received a clear liquid diet on the first postoperative day, then advanced to a regular diet as tolerated (absence of nausea, vomiting, or symptomatic abdominal distension) according to the standard practice of the Gynecologic Oncology Service at SUNY-Stony Brook. Patients allocated to a regular diet received a regular diet on the first postoperative day in the absence of nausea, vomiting, or symptomatic abdominal distension. Patients in either group who were unable to tolerate their diet were given nothing by mouth and received intravenous hydration until resolution of their symptoms, at which time they were restarted on a clear liquid diet and advanced as tolerated. A nasogastric tube was placed for intractable nausea, vomiting, or symptomatic abdominal distension. Standard criteria for discharge were used for all study patients.

The a priori sample size was calculated on data that indicate postoperative nausea, vomiting, and abdominal distension occur in 40% of gynecologic oncology patients who receive clear liquids as their first postoperative meal after intraabdominal surgery.3 We believed that a 50% increase in the incidence of postoperative nausea, vomiting, and abdominal distension would be unacceptable. With a two-tailed {alpha} value of .05 and a ß value of .2, a minimum of 107 patients were required for each treatment group.

Statistical analysis was performed using NCSS 2000 (Number Cruncher Statistical Systems, Kaysville, UT) on a Dell Dimension XPS T700r (Dell Computers, Round Rock, TX). Categoric variables (ie, incidence of postoperative complications) were analyzed by the {chi}2 test with Yates correction or Fisher exact test, as appropriate. Continuous variables (ie, time to first passage of flatus) were assessed initially for normality numerically by testing skewness, kurtosis, and omnibus normality and visually with a probability plot. Normally distributed continuous variables were analyzed by the unpaired Student t test. Non-normally distributed continuous variables were analyzed by the Wilcoxon rank-sum test. Tests were two-tailed when appropriate, and P < .05 was considered significant.


    RESULTS
 TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Between February 17, 2000, and October 16, 2001, 254 patients were enrolled in this trial, representing 64% of eligible patients. Each of the remaining patients declined to participate for personal reasons. One patient in the clear liquid group was excluded as a protocol violation because she did not undergo intraabdominal surgery (tandem and ovoid insertion). Eight patients were not evaluable, five in the clear liquid diet group and three in the regular diet group. Of these, one patient in each group died of sepsis and multiorgan system failure with 36 hours of surgery. The remaining patients required extended (>12 hours) postoperative intubation in the surgical intensive care unit.

Tables 1Go and 2Go summarize the demographic and surgical distributions. Both groups were similar in age, disease, surgical procedure distribution, surgery length, and estimated blood loss.


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Table 1. Patient Information
 

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Table 2. Surgical Information
 
Table 3Go summarizes gastrointestinal outcome. The incidence of nausea, vomiting, abdominal distention, frequency and duration of nasogastric tube use, passage of flatus before discharge, and percentage of patients who tolerated clear liquid and regular diets on the first attempt were comparable for both groups. For patients who were intolerant of the first attempt at either a clear liquid or regular diet, the time to tolerance was comparable for both groups. The time to development of bowel sounds, passage of flatus, and hospital stay was comparable for both groups.


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Table 3. Gastrointestinal Information
 
Table 4Go summarizes the incidence of major postoperative complications. Febrile morbidity, pneumonia, wound complications, and atelectasis occurred equally in both groups. The other major postoperative complications in the regular diet group were gastrointestinal bleeding (n = 2), pulmonary embolism (n = 2, one of which was fatal and one of which was associated with a myocardial infarction), infection (n = 2, a cuff abscess and a urinary tract infection), cardiac arrythmia (n = 1), wound dehiscence (n = 1), and hypoxia (n = 1). In the clear liquid diet group, the other major postoperative complications were cardiac arrythmia (n = 2), myocardial infarction (n = 2, one of which was associated with gastrointestinal bleeding and sepsis), and urinary tract infection (n = 1). There were no known anastamotic complications or aspirations in either group. No patient required urgent reoperation.


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Table 4. Major Postoperative Complications
 
Table 5Go summarizes the postoperative changes in hematologic variables and electrolytes, which were comparable for both groups.


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Table 5. Hematological Parameters and Electrolytes
 

    DISCUSSION
 TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
The venerable approach to dietary management of the postoperative patient has been dictated by unsubstantiated surgical dogma. Traditionally, patients receive nothing by mouth until resolution of the postoperative ileus is confirmed by passage of flatus, receive clear liquids as the first postoperative meal, and are advanced to a regular diet as tolerated in the absence of nausea, vomiting, or symptomatic abdominal distension. This protocol evolved from the belief that clear liquids are more easily tolerated in the immediate postoperative period. Early initiation of a regular diet, it was feared, could lead to such serious complications as anastamotic breakdown, aspiration, and wound separation.7

Scientific evidence is accumulating to refute these historic dictums, leading to substantial changes in postoperative dietary management. It is clear that the traditional view of the postoperative ileus as complete paralysis of the bowel without any functional activity is incorrect. In the unfed state, 500–1000 mL of gastric fluid is secreted daily, stimulating the secretion of a comparable amount of pancreatic fluid.8 Thus, the small intestine is presented with 1–2 L of endogenous fluid daily. Motility studies have shown the presence of small intestinal tonus and peristalsis within several hours of intraabdominal surgery.9,10 Gastric emptying and small intestinal absorptive capacity return within 24 hours, colonic activity resumes with 48 hours, and rectosigmoid function returns within 72 hours after intraabdominal surgery.11–13 Clinically, it has been shown conclusively that routine use of postoperative nasogastric decompression does not provide any substantial benefit.2,14,15 Similarly, early initiation of a clear liquid diet and oral analgesia have been shown to be safe and well tolerated.3,14,16 Because most patients traverse the postoperative period without substantial gastrointestinal difficulty, it seems reasonable to resume oral intake without waiting for the traditional signs that the postoperative ileus has resolved.

Recently, the need to withhold a regular diet in favor of clear liquids has been questioned. Studies of patients who had intraabdominal surgery, cesarean, and benign gynecologic surgery found that initiation of a regular diet immediately after surgery was not associated with increased gastrointestinal complaints compared with starting with clear liquids.17–19 In contrast to the patients in those studies, gynecologic oncology patients typically have serious concomitant medical problems and undergo multiple procedures during their surgery. Therefore, we undertook this study to address the safety and efficacy of a regular diet as the first postoperative meal after intraabdominal surgery in this patient population.

Is a regular diet as the first postoperative meal safe? The incidence of postoperative nausea was comparable in both groups, occurring in approximately 20% of the patients. These episodes were transient and occurred most frequently within the first 24 hours. The early occurrence and transient nature suggests that these episodes might have been associated with surgical manipulation of the peritoneum or retroperitoneal structures or with residual effects of anesthesia, as prophylactic anti-emetics were not allowed by the protocol. Furthermore, these episodes did not translate into worse gastrointestinal difficulties, as the incidences of vomiting, symptomatic abdominal distension, and nasogastric tube decompression were substantially lower than the incidence of nausea and did not differ between the two groups. Importantly, the incidence of major postoperative complications was low and was comparable between the two groups. Similar results have been reported in studies of patients who had cesarean or benign gynecologic surgery.18,19

It has been suggested that clear liquids are swallowed easier and leave the stomach quicker than solid food.17 However, it is also widely accepted that liquids are more easily aspirated because of their rapid transit through the oropharynx. Postoperative pain and sedative medication can compromise glottic closure and the cough reflex sufficiently to increase the risk of aspiration, suggesting that a regular diet might be safer than liquids in the immediate postoperative period.17 Furthermore, the standard clear liquid diet is composed of hyperosmolar liquids (broth, Jell-O, and juices) that could slow gastric emptying.20

Is a regular diet as the first postoperative meal efficacious? The patients in the early regular diet tolerated a regular diet 1 day earlier than the patients in the clear liquid group. Most patients in both groups tolerated initiation and advancement of their diet on the first attempt. For the few patients who did not tolerate their diet on the first attempt, the time to tolerance was comparable in both groups. Nearly identical results have been reported in patients who had intraabdominal surgery (91.9–92.5% tolerance) and benign gynecologic surgery (94.2–97% tolerance).17,19 In one study, the authors commented that "advising the patient to proceed cautiously and eat only what is appealing leads to greater patient satisfaction."17

In a similar study, the authors suggest that "consumption of food postoperatively might stimulate bowel peristalsis and earlier return of bowel function, explaining the decreased nausea in the early feeding group."19 Along these lines, we found that bowel sounds were typically present on the first morning after surgery. Despite this, approximately 50% of the patients in both groups did not pass flatus before being discharged from the hospital. For the patients who did pass flatus in the hospital, the average interval was 2.8 days and did not differ significantly between the two groups. These findings substantiate our belief that the traditional physical signs of resolution of the postoperative ileus (eg, passage of flatus or bowel movements) should not be major determinants of dietary management.

The results of our study indicate that a regular diet as the first meal after intraabdominal surgery is safe and efficacious. With this study, we have furthered the transition from traditional surgical dogma to a contemporary evidenced-based approach to postoperative dietary management of the gynecologic oncology patient. Except in highly selected circumstances, such as extensive bowel surgery in patients with prior irradiation or substantial edema from bowel obstruction, we have eliminated routine postoperative nasogastric decompression. We have discontinued using a patient-controlled analgesia machine in favor of regularly scheduled intramuscular opioid injections for the first postoperative night and switching to oral medications for the remainder of the hospitalization. We provide a regular diet as the first postoperative meal within 12 hours of surgery.


    Footnotes
 
PII S0029-7844(02)02067-7

Received January 14, 2002. Received in revised form March 11, 2002. Accepted March 21, 2002.


    REFERENCES
 TOP
 ABSTRACT
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
1. Morris M, Burke TW. Surgery of the gastrointestinal tract in relation to gynecology. In: Gershenson DM, DeCherney AH, Curry SL, eds. Operative gynecology. Philadelphia: WB Saunders, 1993:390–425.

2. Pearl ML, Valea FA, Fischer M, Chalas E. A randomized controlled trial of postoperative nasogastric tube decompression in gynecologic oncology patients undergoing intraabdominal surgery. Obstet Gynecol 1996;88:399–402.[Abstract]

3. Pearl ML, Valea FA, Fischer M, Mahler L, Chalas E. A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intraabdominal surgery. Obstet Gynecol 1998;92:94–7.[Abstract]

4. Pearl ML, Thompson J, McCauley DL, Mahler L, Valea FA, Chalas E. A randomized controlled trial of early oral analgesia in gynecologic oncology patients undergoing intraabdominal surgery. Obstet Gynecol 2002;99: 704–8.[Abstract/Free Full Text]

5. Reissman P, Teoh TA, Cohen SM, Wexner SD. Is early oral feeding safe after elective colorectal surgery? Ann Surg 1995;222:73–7.[Medline]

6. Bickel A, Shtamler B, Mizrahi S. Early oral feeding following removal of nasogastric tube in gastrointestinal operations. Arch Surg 1992;127:287–9.[Abstract]

7. Bowling TE. Does disorder of gastrointestinal motility affect food intake in the post-surgical patient? Proc Nutr Soc 1994;53:151–7.[Medline]

8. Bufo AJ, Feldman S, Daniels GA, Lieberman RC. Early postoperative feeding. Dis Colon Rectum 1994;37: 1260–5.[Medline]

9. Ross B, Watson BW, Kay AW. Studies on the effect of vagotomy on small intestinal motility using the radiotelemetry capsule. Gut 1963;4:77–81.

10. Woods JH, Erickson LW, Condon RE, Schulte WJ, Sillin LE. Post-operative ileus. A colonic problem? Surgery 1978;84:527–33.[Medline]

11. Cox AG. Small intestinal absorption before and after vagotomy in man. Lancet 1962;ii:1075–7.

12. Wells C, Tinckler LF, Rawlinson K, Howell J, Saunders J. Post-operative gastrointestinal motility. Lancet 1964;i: 4–10.

13. Wilson JP. Post-operative motility of the large intestine in man. Gut 1975;16:689–92.[Abstract/Free Full Text]

14. Cutillo G, Maneschi F, Franchi M, Giannice R, Scambia G, Benedetti-Panici P. Early feeding compared with nasogastric decompression after major oncologic gynecologic surgery: A randomized trial. Obstet Gynecol 1999;93: 41–5.[Abstract/Free Full Text]

15. Cheatham ML, Chapman WC, Key SP, Sawyers JL. A meta-analysis of selective versus routine nasogastric decompression after elective laparotomy. Ann Surg 1995; 221:469–78.[Medline]

16. Schilder JM, Hurteau JA, Look KY, Moore DH, Raff G, Stehman FB, et al. A prospective controlled trial of early postoperative oral intake following major abdominal gynecologic surgery. Gynecol Oncol 1997;67:235–40.[Medline]

17. Jeffery KM, Harkins B, Cresci GA, Martindale RG. The clear liquid diet is no longer a necessity in the routine postoperative management of surgical patients. Am Surg 1996;62:167–70.[Medline]

18. Patolia DS, Hilliard RLM, Toy EC, Baker B III. Early feeding after cesarean: Randomized trial. Obstet Gynecol 2001;98:113–6.[Abstract/Free Full Text]

19. MacMillan SLM, Kammerer-Doak D, Rogers RG, Parker KM. Early feeding and the incidence of gastrointestinal symptoms after major gynecologic surgery. Obstet Gynecol 2000;96:604–8.[Abstract/Free Full Text]

20. Rombeau JL, Caldwell MD. Clinical nutrition: Enteral and tube feeding. 2nd ed. Philadelphia: WB Saunders, 1990:11–34.




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