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doi:10.1111/jog.12246
J. Obstet. Gynaecol. Res. Vol. 40, No. 6: 1649–1652, June 2014
Randomized clinical trial comparing postoperative outcomes of early versus late oral feeding after cesarean section Nasrin Jalilian and Mohammad Rasoul Ghadami Maternity Research Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran
Abstract Aim: Oral feeding is likely to have an impact on early return of normal bowel function after uncomplicated surgery including cesarean section. This study compared postoperative outcomes of early versus late oral feeding regimes after cesarean section. Methods: In this clinical trial, 140 pregnant women who underwent elective cesarean section with regional anesthesia were randomized into two feeding groups. In the early oral and delayed oral feeding groups, liquid diets were commenced 2 and 8 h after surgery, respectively. Patients able to tolerate the liquid diet were then gradually introduced to the regular diet. Main clinical outcomes included duration of hospital stay, time to return of normal bowel function and postoperative gastrointestinal complications. Results: Time to return of bowel movement (7.8 ± 2.9 vs 11.7 ± 5 h, P < 0.0001) and time to mobilization (10.7 ± 7.7 vs 13.5 ± 5.9 h, P = 0.015) occurred significantly earlier in the early feeding group. Conclusion: Early oral feeding reduces the time required for return of normal bowel function. This is without significant detrimental effects on the incidence of gastrointestinal complications. Key words: bowel function, cesarean section, early oral feeding, late oral feeding.
Introduction Cesarean section continues to be the most common surgical delivery procedure. Its rate of use continues to increase globally. Improvements in this procedure have been shown to reduce the incidence of complications and length of hospital stay. These clinical parameters depend on multiple factors including wound complications, fever and bowel function. In particular, oral feeding has a major impact on postoperative return of normal bowel function. It has been suggested that a liquid diet can be successfully introduced on day 1 after uncomplicated surgery. A normal diet can then be given on return of flatus or bowel function.1
Until recent years, oral fluids were not given until at least 8 h post-cesarean surgery. This rationale relates to potential complications such as nausea, vomiting and abdominal distention, which may follow oral feeding before return of bowel function. These may lead to wound dehiscence, anastomotic complications or aspiration.2 With changing surgical attitudes, however, the benefits of early oral feeding, especially after cesarean section, are being reconsidered. Early feeding can reduce the rate of body protein depletion, improve wound healing, impact positively on psychological status, and reduce the incidence of nosocomial infections, length of hospital stay and treatment costs.3 Because the majority of cesarean surgery is performed
Received: June 10 2013. Accepted: July 22 2013. Reprint request to: Dr Mohammad Rasoul Ghadami, Maternity Research Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran. Email: [email protected]
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
1649
N. Jalilian and M. R. Ghadami
under regional anesthesia with low intestinal manipulation and patients are mostly young, some researchers believe that these women can receive their usual diet as early as 4–8 h after surgery.4–6 There are even some studies which suggest that oral intake can be commenced within the first few hours after cesarean section.2,7 However, the optimum time for this has not yet been fully agreed. In this study, we compare outcomes of early feeding with traditional oral feeding regimes after cesarean section.
Methods This randomized clinical trial was conducted in the Imam Reza Hospital, Kermanshah, Iran after approval from the ethics committee of the medical university from April 2011 through June 2012, and registered under code IRCT2012102411245N1 at the Iranian Center of Clinical Trials (IRCT.ir). Signed informed consent was obtained from selected pregnant women undergoing elective cesarean section. Exclusion criteria included general anesthesia, intraoperative blood loss of more than 1000 mL, magnesium sulfate therapy, gastrointestinal disorders and complications during surgery such as bowel and bladder injury. All patients underwent regional anesthesia and cesarean section by the Pfannenstiel–Kerr method. After cesarean section, women were randomized into two study groups: early or late feeding. Randomization was carried out using a computergenerated random number table and was sealed in opaque envelopes that were opened by a gynecology resident. During the 14-month study period, 723 women underwent cesarean section. One hundred and forty of these were randomized postoperatively to the two study groups, with 70 women in each group. The early feeding group received 250 mL of fruit juice 2 h after surgery and the late feeding group women received a liquid diet commencing 8 h after surgery. Those able to tolerate the liquid diet were then gradually introduced to a normal diet. Intravenous fluids were discontinued when patients were able to tolerate the normal diet. During hospitalization, patients were clinically assessed by gynecology residents every 2 h. Onset of bowel movements, presence of abdominal distention, time to passage of flatus, defecation and presence of gastrointestinal symptoms such as nausea and vomiting were assessed. Patients with evidence of ileus were excluded from the study and treated with intravenous
1650
fluids, limitation of oral intake and nasogastric suction, if considered necessary. Patients who tolerated the normal diet with normal bowel movements and who lacked fever for at least 48 h after surgery were discharged from hospital. Based on our pilot study, in order to detect a mean difference of 3 h in the time to return of bowel movement, a minimum sample size of 60 patients for each group was required, with an alpha of 0.05, an expected standard deviation of less than 5 h and a power of 0.90. Statistical analysis was performed with SPSS version 16 software (SPSS, Chicago, IL, USA). Continuous variables were analyzed with independent Student’s t-test. Categorical variables were analyzed with χ2-test and Fisher’s exact test.
Results None of the women were lost for outcome analysis. Figure 1 summarizes the trial profile. There were no significant differences between groups regarding baseline characteristics or indications for cesarean section (Table 1). A comparison of the postoperative variables of women in the early feeding group versus the late feeding group is summarized in Table 2. As shown, time to return of bowel movement (7.8 ± 2.9 vs 11.7 ± 5 h, P < 0.0001) and time to mobilization (10.7 ± 7.7 vs 13.5 ± 5.9 h, P: 0.015) occurred significantly earlier in the early feeding than in the late feeding group. The mean duration of passage of flatus appeared to be shorter in the early feeding group
Figure 1 Trial profile.
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Early versus late feeding after cesarean
Table 1 Demographics and operation characteristics
Age (year) Gestational age (weeks) Gravidity (n) 1 2 ≥3 Operation time (min) Estimated blood loss (mL) Cesarean indication Malpresentation CPD Meconium aspiration Prior cesarean section Other
Early feeding (n = 70)
Late feeding (n = 70)
P-value
27.8 ± 4.1 38.9 ± 1.1
29.1 ± 5.8 38.6 ± 1
0.156 0.601
28 31 11 41.4 ± 9 804 ± 105
25 25 20 46.5 ± 9.3 772 ± 84
0.728 0.388 0.103 0.658 0.764
7 14 10 31 8
13 12 8 26 11
0.227 0.828 0.801 0.492 0.623
Data are presented as mean ± standard deviation or number. CPD, cranio-pelvic disproportion.
Table 2 Postoperative outcomes
Duration of hospitalization (h) Bowel movement (h) Passage of flatus (h) First defecation (h) Mobilization (h) Nausea (n) Vomiting (n) Abdominal distention (n) Fever (n) Wound infection (n) Urinary tract infection (n) Rehospitalization (n)
Early feeding (n = 70)
Late feeding (n = 70)
P-value
48.3 ± 3.6 7.8 ± 2.9 13.6 ± 6.8 24.4 ± 11.6 10.7 ± 7.7 12 4 3 5 0 2 0
48.7 ± 6.3 11.7 ± 5 15.4 ± 5.8 26 ± 10.7 13.5 ± 5.9 18 9 14 4 0 1 0
0.658
doi:10.1111/jog.12246
J. Obstet. Gynaecol. Res. Vol. 40, No. 6: 1649–1652, June 2014
Randomized clinical trial comparing postoperative outcomes of early versus late oral feeding after cesarean section Nasrin Jalilian and Mohammad Rasoul Ghadami Maternity Research Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran
Abstract Aim: Oral feeding is likely to have an impact on early return of normal bowel function after uncomplicated surgery including cesarean section. This study compared postoperative outcomes of early versus late oral feeding regimes after cesarean section. Methods: In this clinical trial, 140 pregnant women who underwent elective cesarean section with regional anesthesia were randomized into two feeding groups. In the early oral and delayed oral feeding groups, liquid diets were commenced 2 and 8 h after surgery, respectively. Patients able to tolerate the liquid diet were then gradually introduced to the regular diet. Main clinical outcomes included duration of hospital stay, time to return of normal bowel function and postoperative gastrointestinal complications. Results: Time to return of bowel movement (7.8 ± 2.9 vs 11.7 ± 5 h, P < 0.0001) and time to mobilization (10.7 ± 7.7 vs 13.5 ± 5.9 h, P = 0.015) occurred significantly earlier in the early feeding group. Conclusion: Early oral feeding reduces the time required for return of normal bowel function. This is without significant detrimental effects on the incidence of gastrointestinal complications. Key words: bowel function, cesarean section, early oral feeding, late oral feeding.
Introduction Cesarean section continues to be the most common surgical delivery procedure. Its rate of use continues to increase globally. Improvements in this procedure have been shown to reduce the incidence of complications and length of hospital stay. These clinical parameters depend on multiple factors including wound complications, fever and bowel function. In particular, oral feeding has a major impact on postoperative return of normal bowel function. It has been suggested that a liquid diet can be successfully introduced on day 1 after uncomplicated surgery. A normal diet can then be given on return of flatus or bowel function.1
Until recent years, oral fluids were not given until at least 8 h post-cesarean surgery. This rationale relates to potential complications such as nausea, vomiting and abdominal distention, which may follow oral feeding before return of bowel function. These may lead to wound dehiscence, anastomotic complications or aspiration.2 With changing surgical attitudes, however, the benefits of early oral feeding, especially after cesarean section, are being reconsidered. Early feeding can reduce the rate of body protein depletion, improve wound healing, impact positively on psychological status, and reduce the incidence of nosocomial infections, length of hospital stay and treatment costs.3 Because the majority of cesarean surgery is performed
Received: June 10 2013. Accepted: July 22 2013. Reprint request to: Dr Mohammad Rasoul Ghadami, Maternity Research Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran. Email: [email protected]
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
1649
N. Jalilian and M. R. Ghadami
under regional anesthesia with low intestinal manipulation and patients are mostly young, some researchers believe that these women can receive their usual diet as early as 4–8 h after surgery.4–6 There are even some studies which suggest that oral intake can be commenced within the first few hours after cesarean section.2,7 However, the optimum time for this has not yet been fully agreed. In this study, we compare outcomes of early feeding with traditional oral feeding regimes after cesarean section.
Methods This randomized clinical trial was conducted in the Imam Reza Hospital, Kermanshah, Iran after approval from the ethics committee of the medical university from April 2011 through June 2012, and registered under code IRCT2012102411245N1 at the Iranian Center of Clinical Trials (IRCT.ir). Signed informed consent was obtained from selected pregnant women undergoing elective cesarean section. Exclusion criteria included general anesthesia, intraoperative blood loss of more than 1000 mL, magnesium sulfate therapy, gastrointestinal disorders and complications during surgery such as bowel and bladder injury. All patients underwent regional anesthesia and cesarean section by the Pfannenstiel–Kerr method. After cesarean section, women were randomized into two study groups: early or late feeding. Randomization was carried out using a computergenerated random number table and was sealed in opaque envelopes that were opened by a gynecology resident. During the 14-month study period, 723 women underwent cesarean section. One hundred and forty of these were randomized postoperatively to the two study groups, with 70 women in each group. The early feeding group received 250 mL of fruit juice 2 h after surgery and the late feeding group women received a liquid diet commencing 8 h after surgery. Those able to tolerate the liquid diet were then gradually introduced to a normal diet. Intravenous fluids were discontinued when patients were able to tolerate the normal diet. During hospitalization, patients were clinically assessed by gynecology residents every 2 h. Onset of bowel movements, presence of abdominal distention, time to passage of flatus, defecation and presence of gastrointestinal symptoms such as nausea and vomiting were assessed. Patients with evidence of ileus were excluded from the study and treated with intravenous
1650
fluids, limitation of oral intake and nasogastric suction, if considered necessary. Patients who tolerated the normal diet with normal bowel movements and who lacked fever for at least 48 h after surgery were discharged from hospital. Based on our pilot study, in order to detect a mean difference of 3 h in the time to return of bowel movement, a minimum sample size of 60 patients for each group was required, with an alpha of 0.05, an expected standard deviation of less than 5 h and a power of 0.90. Statistical analysis was performed with SPSS version 16 software (SPSS, Chicago, IL, USA). Continuous variables were analyzed with independent Student’s t-test. Categorical variables were analyzed with χ2-test and Fisher’s exact test.
Results None of the women were lost for outcome analysis. Figure 1 summarizes the trial profile. There were no significant differences between groups regarding baseline characteristics or indications for cesarean section (Table 1). A comparison of the postoperative variables of women in the early feeding group versus the late feeding group is summarized in Table 2. As shown, time to return of bowel movement (7.8 ± 2.9 vs 11.7 ± 5 h, P < 0.0001) and time to mobilization (10.7 ± 7.7 vs 13.5 ± 5.9 h, P: 0.015) occurred significantly earlier in the early feeding than in the late feeding group. The mean duration of passage of flatus appeared to be shorter in the early feeding group
Figure 1 Trial profile.
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Early versus late feeding after cesarean
Table 1 Demographics and operation characteristics
Age (year) Gestational age (weeks) Gravidity (n) 1 2 ≥3 Operation time (min) Estimated blood loss (mL) Cesarean indication Malpresentation CPD Meconium aspiration Prior cesarean section Other
Early feeding (n = 70)
Late feeding (n = 70)
P-value
27.8 ± 4.1 38.9 ± 1.1
29.1 ± 5.8 38.6 ± 1
0.156 0.601
28 31 11 41.4 ± 9 804 ± 105
25 25 20 46.5 ± 9.3 772 ± 84
0.728 0.388 0.103 0.658 0.764
7 14 10 31 8
13 12 8 26 11
0.227 0.828 0.801 0.492 0.623
Data are presented as mean ± standard deviation or number. CPD, cranio-pelvic disproportion.
Table 2 Postoperative outcomes
Duration of hospitalization (h) Bowel movement (h) Passage of flatus (h) First defecation (h) Mobilization (h) Nausea (n) Vomiting (n) Abdominal distention (n) Fever (n) Wound infection (n) Urinary tract infection (n) Rehospitalization (n)
Early feeding (n = 70)
Late feeding (n = 70)
P-value
48.3 ± 3.6 7.8 ± 2.9 13.6 ± 6.8 24.4 ± 11.6 10.7 ± 7.7 12 4 3 5 0 2 0
48.7 ± 6.3 11.7 ± 5 15.4 ± 5.8 26 ± 10.7 13.5 ± 5.9 18 9 14 4 0 1 0
0.658
