The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section: A Randomized Controlled Trial
Phase: NA
Conditions: Postoperative Ileus, Cesarean Section Complications, Caffeine
Sponsor: Ain Shams University

The effect of coffee ingestion in prevention of 
post-operative ileus after caesarean section: A 
randomized placebo-controlled trial 
Protocol of Thesis 
Submitted for Partial Fulfillment of Master Degree  
in Obstetrics & Gynecology 
Presented by: 
Madonna Gamal Garas Benyamine 
 
Under Supervision of  
Prof. Amr Abd El-Aziz Mahmoud Nadim Professor of 
Obstetrics & Gynecology,  
Faculty of Medicine – Ain Shams University 
 
Assistant Prof.  Ahmed El-Sayed Hassan Elbohoty 
Assistant Professor of Obstetrics & Gynecology 
Faculty of Medicine – Ain Shams University 
 
 Dr. Reda Mokhtar Kamal Ghanem 
Lecturer of Obstetrics & Gynecology 
Faculty of Medicine – Ain Shams University 
Faculty of Medicine 
Ain Shams University 
18/01/2018 

 
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Introduction 
Caesarian section delivery has become more prevalent than the 
vaginal delivery in Egypt. According to the Demographic and Health 
Survey (DHS) in 2014, 52 % of women in Egypt give birth by caesarian 
section. This makes the caesarian section one of the commonest 
abdominal surgeries in Egypt. 
Many complications could occur after an abdominal surgery.  So after 
a caesarian section, complications that are variable in its intensity could 
occur. One of the commonest but yet serious is the postoperative ileus. 
(Sunil et al, 2001). Postoperative ileus complicates 26-31% of caesarian 
section deliveries. (Teoh et al, 2007) 
Postoperative ileus is a predictable delay in gastrointestinal 
motility that occurs after abdominal surgery. Probable causes include 
disruption of the sympathetic/parasympathetic pathways to the 
gastrointestinal tract, inflammatory changes through multiple pathways, 
and the use of opioids for the management of postoperative pain. 
(Artinyan et al, 2011) 
 
         Postoperative ileus is presented with nausea, vomiting, abdominal 
distention, abdominal tenderness, and delayed passage of flatus and stool. 
These symptoms would remarkably worsen the patients’ quality of life, 
increase length of hospital stay, and increase costs associated with 
postoperative recovery. (Holte et al, 2002) 
 
         Although ileus is so prevalent, preventative therapeutic options are 
still limited. Many trials have been made to prevent ileus, including 
administration of prokinetic drugs such as serotonin receptor antagonists 
(Toyomasu et al, 2011), neostigmine (Drake et al, 2016), alvimopam 
(Tan et al, 2007), and ghrelin agonists (Beck et al, 2014), early 
resumption of feeding (Zhuang et al, 2013), gum chewing (Ertas et al, 
2013) and adequate pain control (Bragg et al, 2015) ,Unfortunately, none 
of these strategies has been completely successful. 
 

 
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         Coffee is one the most popular drinks in Egypt and the whole world. 
Several researches were done worldwide to study the effect of the 
caffeine present in coffee and resumption of intestinal motility after 
various abdominal surgeries. (Brown et al, 1990) (Müller et al, 2012). 
Recently the effect of coffee on prevention of postoperative ileus after 
caesarian section was researched (Rabiepoor et al, 2017). 
          That’s why we are concerned in our study to determine the efficacy 
of coffee in prevention of postoperative ileus. 
 
 

 
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Aim of the Work 
 
This study aims to assess the value of drinking coffee in promoting 
intestinal motility and prevention of postoperative ileus after elective 
caesarean section. 
Research question: 
After elective caesarean section, can drinking coffee lead to early 
intestinal motility and prevent postoperative ileus? 
Research hypothesis: 
Drinking coffee promotes intestinal motility thus prevent 
postoperative ileus and improve the postoperative intestinal symptoms 
after elective caesarean section. 
 
Primary outcome: 
 
- A change in the number of hours for the patients to pass flatus 
for the first time after an elective caesarean. 
 
Secondary outcomes: 
- A change in the number of hours for the patients to have their 
first intestinal sound to be heard by a stethoscope. 
- A difference in the number of hours for the patients to pass 
stool. 
- A difference in the number of the patients’ hospital stay hours. 
 
 
 

 
4
 
Patients and Methods 
This study will be conducted in the 1 year period starting from 
October 2017, at Ain Shams Maternity Hospital. 
 
Patients: 
Patients will be recruited from emergency unit and inpatient wards in Ain 
Shams University maternity hospital.  
Inclusion criteria: 
1- Caesarean section. 
2- Spinal anesthesia. 
3- Total surgery time less than 90 minutes. 
 
Exclusion criteria: 
1- Previous complicated abdominal surgery or caesarean section with 
extensive adhesions requiring extensive dissection or intestinal 
manipulation. 
2- Intraoperative intestinal complications. 
3- Intraoperative respiratory complication. 
4- Chronic intestinal diseases: irritable or inflammatory bowel 
diseases. 
5- Chronic diarrhea or constipation. 
6- Using laxatives pre-operatively. 

 
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7- Known hypersensitivity to caffeine. 
8- Thyroid or hepatic disease. 
9- Cardiac arrhythmias. 
 
 
Methods: 
Study type: 
A single blinded, randomized, placebo-controlled trial. 
  
Sample Size Justification: 
According to The number of samples was calculated according to a 
study by Müller et al, (2010) considering the power of 90%, 
confidence 95% and significant level of 0.05, the sample size needed 
is 544 cases, and with adding 10% for occasional cases’ drop out so 
the total sample size would be 600 cases, divided into two groups, 300 
patients each, one in the intervention group and the other is the 
placebo. 
Study design: 
 This study will include 600 patients undergoing their caesarean section. 
 The study aims will be explained to all patients and an informed written 
consent will be taken. 
 All recruited patients will be divided into two groups according to a 
random selection by the primary researcher who consecutively will open 
sequentially numbered, opaque, sealed envelopes containing colored 

 
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cards, blue card group will represent the intervention group and the red 
card group will represent the placebo group. 
 
 
Procedure: 
- For all patients, the anesthetic used will be Marcaine® Spinal 
heavy 0.5% and fentanyl and for post-operative pain, ketorolac 
will be used. 
- Through Pfannenstiel incision, transverse lower segment uterine 
incision is done, with the duration of the surgery not exceeding 
90 minutes.  
- Patients will not be permitted to drink or eat, except for the 
drink offered by the researcher, till passing flatus. 
- Early ambulation was encouraged. 
- A stethoscope will be used to detect the first intestinal 
movement each 15 mins after the surgery. 
- The patients will be advised to notify the researcher when they 
pass both flatus and feces. 
Intervention: 
 
- The intervention plan will be performed within the first 24 
hours after the surgery. 
-  Provided by the researcher within 10 minutes, patients will 
drink 100cc sugar-free coffee at 3, 6 and 9 hours after the 
surgery, and the control group will drink 100cc sugar-free 
decaffeinated coffee at the same intervals. 
- No other liquid will be allowed till passage of flatus and feces 
in the first day of surgery. 
-  We will use Nescafe Gold ® coffee (10g per 100cc water) for 
all the patients in the intervention group. 

 
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- We will use Nescafe Gold DECAF coffee (10g per 100cc 
water) for all the patients in the control group. 
History taking: 
- Age, parity, gestational age at time of delivery. 
- Cause of caesarean section. 
- Any past medical history or drug intake.  
 
THE TRIAL FLOW CHART 
- 
Assessed for eligibility (n=  )
 
-  Excluded (n=   ) 
   Not meeting inclusion criteria (n= 
 )
 
- Analysed  (n=  ) 
 Excluded from analysis (give reasons) (n=  
) 
Excluded after surgery (give reasons) (n=  )
 
Allocated to intervention (n=  )
 
 Received allocated intervention (n=  )
 
 Did not receive allocated intervention (n= ) 
Excluded after surgery (give reasons) 
(n=  )
 
Allocated to control (n=  )
 
 Received allocated placebo (n=  )
 
 Did not receive allocated placebo (n=  ) 
- Analysed  (n=  ) 
 Excluded from analysis (give 
reasons) (n=  ) 
Allocation 
Analysis 
Follow-Up 
Randomized (n=  )
 
Enrollment 

 
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Data Analysis: 
Data analysis will be performed by SPSS 16.0 using descriptive statistics 
tools, including mean, standard deviation and figures. A t-test will be 
used to compare mean values of the two groups. P-values, smaller than 
0.05, were considered statistically significant. 
 
 
 
Ethical and legal aspects: 
Delegation of investigator responsibilities: 
The investigator will ensure the all persons assisting in the trial are 
adequately informed about the protocol and their trial-related duties are 
well explained, and will maintain a list of sub-investigators and other 
appropriately qualified persons to whom significant trial related duties 
were delegated.  
 
Patient information and informed consent: 
Before being admitted to the clinical trial the patient must consent 
to participate after the nature, scope, and possible consequences of the 
clinical trial have been explained in a form understandable to her. 
Confidentiality: 
Only the patient file numbers and patient initials will be recorded 
in the case report form. 
The researcher will keep a patient identification list (patient 
number and corresponding names and contacts) to enable records to be 
identified and enable records to be identified and allow communication 
with the patients. 

 
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Protocol approval: 
Before beginning of the trial and in accordance with the local 
regulation followed, the protocol and all related documents will be 
declared for ethical and research approval by the Council of Obstetrics 
and Gynecology Department, Ain Shams university. 
 
 
 
 
References 
 
• Artinyan A, Nunoo-Mensah JW, et al. 
Prolonged postoperative ileus-definition, risk factors, and 
predictors after surgery. World J Surg 2008; 32(7):1495–1500. 
• Beck DE, Sweeney WB, et al. Prospective, randomized, controlled, 
proof of concept study of the Ghrelin mimetic ipamorelin for the 
management of postoperative ileus in bowel resection patients. Int 
J Colorectal Dis 2014; 29:1527–34. 
• Bragg D, El-Sharkawy AM, et al. Postoperative ileus: Recent 
developments in pathophysiology and management. Clin Nutr 
2015; 34:367-76. 
• Brown S, Cann P, et al. Effect of coffee on distal colon function. 
Gut. 1990; 31(4):450-3.12.  
• Drake TM, Ward AE. Pharmacological management to prevent 
ileus in major abdominal surgery:a systematic review and meta-
analysis. J Gastrointest Surg.2016 Apr 12. 
• Ertas IE, Gungorduk K, et al. Influence of gum chewing on 
postoperative bowel activity after complete staging surgery for 
gynecological malignancies: a randomized controlled trial. 
Gynecol Oncol 2013; 131(1):118-22. 
• Güngördük K, Özdemir IA, et al. Effects of coffee consumption on 
gut recovery after surgery of gynecological cancer patients: a 

 
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randomized controlled trial. Am J Obstet Gynecol 2017; 
216(2):145.e1-145.e7 
• Holte K, Kehlet H. Postoperative ileus: progress towards effective 
management. Drugs 2002;62(18):2603–2615. 
• Müller S, Rahbari N, et al. Randomized clinical trial on the effect 
of coffee on postoperative ileus following elective colectomy. 
British Journal of Surgery. 2012; 99(11):1530-8. 
• Rabiepoor Soheila, Yas Atefeh, et al. Does coffee affect the bowel 
function after caesarean section? Eur J Obstet Gynecol Reprod Biol 
2017; S0301-2115(17)30362-7. 
• Sunil S, Sinha S. Postoperative ileus: a preventable event (Br J 
Surg 2000; 87: 1480‐93).British Journal of Surgery. 2001; 
88(4):594-5.  
• Tan EK, Cornish J, et al . Meta-analysis: Alvimopan vs. placebo in 
the treatment of post-operative ileus. Aliment Pharmacol Ther 
2007; 25:47-57. 
• Teoh W, Shah M, et al. A randomised controlled trial on beneficial 
effects of early feeding post-Caesarean delivery under regional 
anaesthesia. Singapore medical journal. 2007; 48(2):152. 
• Toyomasu Y, Mochiki E, et al. Mosapride citrate improves 
postoperative ileus of patients with colectomy. J Gastrointest Surg 
2011; 15:1361–67. 
• Zhuang CL, Ye XZ, et al. Early versus traditional postoperative 
oral feeding in patients undergoing elective colorectal surgery: a 
metaanalysis of randomized clinical trials. Dig Surg 2013; 30:225-
32. 
 
 
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