<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815877</url>
  </required_header>
  <id_info>
    <org_study_id>AinShamsU2018455</org_study_id>
    <nct_id>NCT03815877</nct_id>
  </id_info>
  <brief_title>The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section.</brief_title>
  <official_title>The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many trials have been made to prevent paralytic ileus , including administration of&#xD;
      prokinetic drugs , early resumption of feeding, gum chewing and adequate pain control.&#xD;
      Unfortunately, none of these strategies has been completely successful. Recently the effect&#xD;
      of caffeine on prevention of postoperative ileus after caesarian section was researched.&#xD;
      That's why this study is designed to determine the efficacy of caffeine in prevention of&#xD;
      postoperative ileus after caesarean section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -Study design: This study will include 600 women undergoing their caesarean section. The&#xD;
      study aims will be explained to all women and an informed written consent will be taken. All&#xD;
      recruited women will be distributed into two groups according to a computerized randomization&#xD;
      table. The researcher consecutively will open sequentially numbered, opaque, sealed envelopes&#xD;
      containing cards with letters either letter (C) or letter (N), Cards with letter (C) will&#xD;
      represent the group who will receive the caffeinated coffee and cards with letter (N) will&#xD;
      represent the group who will receive the decaffeinated coffee&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
        -  For all women, the anesthetic used will be Marcaine® Spinal heavy 0.5% and fentanyl and&#xD;
           for post-operative pain, ketorolac will be used.&#xD;
&#xD;
        -  Through Pfannenstiel incision, transverse lower segment uterine incision is done, with&#xD;
           the duration of the surgery not exceeding 90 minutes&#xD;
&#xD;
        -  women will not be permitted to drink or eat, except for the drink offered by the&#xD;
           researcher, till passing flatus. Early ambulation will be encouraged.&#xD;
&#xD;
        -  A stethoscope will be used to detect the first intestinal movement each hour after the&#xD;
           surgery. The women will be advised to notify the researcher when they pass both flatus&#xD;
           and feces.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
        -  The intervention plan will be performed within the first 24 hours after the surgery.&#xD;
&#xD;
        -  Provided by the researcher within 10 minutes, patients will drink 100cc coffee with 1&#xD;
           tea spoon added sugar at 3, 6 and 9 hours after the surgery, and the control group will&#xD;
           drink 100cc decaffeinated coffee with 1 tea spoon added sugar at the same intervals.&#xD;
&#xD;
        -  No other liquid will be allowed till passage of flatus and feces in the first day of&#xD;
           surgery.&#xD;
&#xD;
        -  Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used&#xD;
           for all the women in the intervention group. Nescafe Gold DECAF coffee (5 gm per 100cc&#xD;
           water containing 5-10 mg of caffeine) will be used for all the women in the control&#xD;
           group.&#xD;
&#xD;
        -  Statistical Package:&#xD;
&#xD;
        -  Data analysis will be performed by Statistical Package for the Social Science (SPSS)&#xD;
           16.0 using descriptive statistics tools, including mean, standard deviation and figures.&#xD;
           A t-test will be used to compare mean values of the two groups. P-values, smaller than&#xD;
           0.05, were considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2018</start_date>
  <completion_date type="Actual">January 12, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>All recruited women will be distributed into two groups according to a computer- generated randomization table. The researcher consecutively will open sequentially numbered, opaque, sealed envelopes containing cards with letters either letter (C) or letter (N), Cards with letter (C) will represent the group who will receive the caffeinated coffee and cards with letter (N) will represent the group who will receive the decaffeinated coffee</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>A change in the number of hours for women to pass flatus for the first time after an elective caesarean section</measure>
    <time_frame>patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass flatus.</time_frame>
    <description>A change the number of hours for women to pass flatus for the first time after an elective caesarean section</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section</measure>
    <time_frame>patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. A stethoscope will be used to detect the first intestinal movement every hour after the surgery</time_frame>
    <description>A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A difference in the number of hours for the women to pass stool after caesarean section.</measure>
    <time_frame>patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass feces.</time_frame>
    <description>A difference in the number of hours for the women to pass stool after caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A difference in the number of the women's hospital stay hours after caesarean section</measure>
    <time_frame>calculating the number of the women's hospital stay hours after caesarean section up to 12 weeks</time_frame>
    <description>A difference in the number of the women's hospital stay hours after caesarean section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of postoperative spinal headache</measure>
    <time_frame>patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher with the occurrence, severity and relief of spinal headache during the hospital stay.</time_frame>
    <description>Occurrence of postoperative spinal headache</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Postoperative Ileus</condition>
  <condition>Cesarean Section Complications</condition>
  <condition>Caffeine</condition>
  <arm_group>
    <arm_group_label>The intervention group (C group receiving caffeinated coffee)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100cc coffee at 3, 6 and 9 hours after the Cesarean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group (N group receiving decaffeinated coffee)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100cc decaf coffee at 3, 6, 9 hours after the Cesarean section</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nescafe Gold ® coffee</intervention_name>
    <description>Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used for all the women in the intervention group.&#xD;
- patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery.</description>
    <arm_group_label>The intervention group (C group receiving caffeinated coffee)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nescafe Gold DECAF® coffee</intervention_name>
    <description>Nescafe Gold DECAF coffee (5 gm per 100cc water containing 5-10 mg of caffeine) will be used for all the women in the control group.&#xD;
the control group will drink 100cc decaffeinated coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery.</description>
    <arm_group_label>The control group (N group receiving decaffeinated coffee)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women undergoing caesarean section&#xD;
&#xD;
          -  Spinal anaesthesia&#xD;
&#xD;
          -  Total surgery time less than 90 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous complicated abdominal surgery or caesarean section with extensive adhesions&#xD;
             requiring extensive dissection or intestinal manipulation.&#xD;
&#xD;
          -  Caesarean section complicated by postpartum hemorrhage or in the women who received&#xD;
             misoprostol.&#xD;
&#xD;
          -  Intraoperative intestinal complications.&#xD;
&#xD;
          -  Intraoperative respiratory complication.&#xD;
&#xD;
          -  Chronic intestinal diseases: irritable or inflammatory bowel diseases.&#xD;
&#xD;
          -  Chronic diarrhea or constipation.&#xD;
&#xD;
          -  Using laxatives pre-operatively.&#xD;
&#xD;
          -  Known hypersensitivity to caffeine&#xD;
&#xD;
          -  Thyroid or hepatic disease.&#xD;
&#xD;
          -  Cardiac arrhythmias&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AMR NADIM</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>REDA GHANEM</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MADONNA BENYAMINE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Artinyan A, Nunoo-Mensah JW, Balasubramaniam S, Gauderman J, Essani R, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr. Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg. 2008 Jul;32(7):1495-500. doi: 10.1007/s00268-008-9491-2.</citation>
    <PMID>18305994</PMID>
  </reference>
  <reference>
    <citation>Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. 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 Dec;29(12):1527-34. doi: 10.1007/s00384-014-2030-8. Epub 2014 Oct 21.</citation>
    <PMID>25331030</PMID>
  </reference>
  <reference>
    <citation>Bragg D, El-Sharkawy AM, Psaltis E, Maxwell-Armstrong CA, Lobo DN. Postoperative ileus: Recent developments in pathophysiology and management. Clin Nutr. 2015 Jun;34(3):367-76. doi: 10.1016/j.clnu.2015.01.016. Epub 2015 Jan 31.</citation>
    <PMID>25819420</PMID>
  </reference>
  <reference>
    <citation>Brown SR, Cann PA, Read NW. Effect of coffee on distal colon function. Gut. 1990 Apr;31(4):450-3. doi: 10.1136/gut.31.4.450.</citation>
    <PMID>2338272</PMID>
  </reference>
  <reference>
    <citation>Drake TM, Ward AE. Pharmacological management to prevent ileus in major abdominal surgery: a systematic review and meta-analysis. J Gastrointest Surg. 2016 Jun;20(6):1253-64. doi: 10.1007/s11605-016-3140-0. Epub 2016 Apr 12.</citation>
    <PMID>27073081</PMID>
  </reference>
  <reference>
    <citation>Ertas IE, Gungorduk K, Ozdemir A, Solmaz U, Dogan A, Yildirim Y. Influence of gum chewing on postoperative bowel activity after complete staging surgery for gynecological malignancies: a randomized controlled trial. Gynecol Oncol. 2013 Oct;131(1):118-22. doi: 10.1016/j.ygyno.2013.07.098. Epub 2013 Jul 29.</citation>
    <PMID>23906657</PMID>
  </reference>
  <reference>
    <citation>Gungorduk K, Ozdemir IA, Gungorduk O, Gulseren V, Gokcu M, Sanci M. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial. Am J Obstet Gynecol. 2017 Feb;216(2):145.e1-145.e7. doi: 10.1016/j.ajog.2016.10.019. Epub 2016 Oct 22.</citation>
    <PMID>27780709</PMID>
  </reference>
  <reference>
    <citation>Holte K, Kehlet H. Postoperative ileus: progress towards effective management. Drugs. 2002;62(18):2603-15. doi: 10.2165/00003495-200262180-00004.</citation>
    <PMID>12466000</PMID>
  </reference>
  <reference>
    <citation>Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.</citation>
    <PMID>22987303</PMID>
  </reference>
  <reference>
    <citation>Rabiepoor S, Yas A, Navaei J, Khalkhali HR. Does coffee affect the bowel function after caesarean section? Eur J Obstet Gynecol Reprod Biol. 2018 Jan;220:96-99. doi: 10.1016/j.ejogrb.2017.07.028. Epub 2017 Aug 4.</citation>
    <PMID>29202396</PMID>
  </reference>
  <reference>
    <citation>Sunil S, Sinha S. Postoperative ileus: a preventable event (Br J Surg 2000; 87: 1480-93). Br J Surg. 2001 Apr;88(4):594-5. doi: 10.1046/j.1365-2168.2001.01787-3.x. No abstract available.</citation>
    <PMID>11298633</PMID>
  </reference>
  <reference>
    <citation>Tan EK, Cornish J, Darzi AW, Tekkis PP. Meta-analysis: Alvimopan vs. placebo in the treatment of post-operative ileus. Aliment Pharmacol Ther. 2007 Jan 1;25(1):47-57. doi: 10.1111/j.1365-2036.2006.03150.x. Epub 2006 Oct 17.</citation>
    <PMID>17042776</PMID>
  </reference>
  <reference>
    <citation>Teoh WH, Shah MK, Mah CL. A randomised controlled trial on beneficial effects of early feeding post-Caesarean delivery under regional anaesthesia. Singapore Med J. 2007 Feb;48(2):152-7.</citation>
    <PMID>17304396</PMID>
  </reference>
  <reference>
    <citation>Toyomasu Y, Mochiki E, Morita H, Ogawa A, Yanai M, Ohno T, Fujii T, Tsutsumi S, Asao T, Kuwano H. Mosapride citrate improves postoperative ileus of patients with colectomy. J Gastrointest Surg. 2011 Aug;15(8):1361-7. doi: 10.1007/s11605-011-1567-x. Epub 2011 May 24.</citation>
    <PMID>21607794</PMID>
  </reference>
  <reference>
    <citation>Zhuang CL, Ye XZ, Zhang CJ, Dong QT, Chen BC, Yu Z. Early versus traditional postoperative oral feeding in patients undergoing elective colorectal surgery: a meta-analysis of randomized clinical trials. Dig Surg. 2013;30(3):225-32. doi: 10.1159/000353136. Epub 2013 Jul 6.</citation>
    <PMID>23838894</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Madonna Gamal Garas Benyamine</investigator_full_name>
    <investigator_title>DR. MADONNA GAMAL GARAS BENYAMINE</investigator_title>
  </responsible_party>
  <keyword>Caffeine</keyword>
  <keyword>Postoperative Ileus</keyword>
  <keyword>Caesarean Section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03815877/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815877
org study id: AinShamsU2018455
nct id: NCT03815877
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many trials have been made to prevent paralytic ileus , including administration of
      prokinetic drugs , early resumption of feeding, gum chewing and adequate pain control.
      Unfortunately, none of these strategies has been completely successful. Recently the effect
      of caffeine on prevention of postoperative ileus after caesarian section was researched.
      That's why this study is designed to determine the efficacy of caffeine in prevention of
      postoperative ileus after caesarean section.
-Study design: This study will include 600 women undergoing their caesarean section. The
      study aims will be explained to all women and an informed written consent will be taken. All
      recruited women will be distributed into two groups according to a computerized randomization
      table. The researcher consecutively will open sequentially numbered, opaque, sealed envelopes
      containing cards with letters either letter (C) or letter (N), Cards with letter (C) will
      represent the group who will receive the caffeinated coffee and cards with letter (N) will
      represent the group who will receive the decaffeinated coffee

      Procedure:

        -  For all women, 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

        -  women will not be permitted to drink or eat, except for the drink offered by the
           researcher, till passing flatus. Early ambulation will be encouraged.

        -  A stethoscope will be used to detect the first intestinal movement each hour after the
           surgery. The women 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 coffee with 1
           tea spoon added sugar at 3, 6 and 9 hours after the surgery, and the control group will
           drink 100cc decaffeinated coffee with 1 tea spoon added sugar at the same intervals.

        -  No other liquid will be allowed till passage of flatus and feces in the first day of
           surgery.

        -  Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used
           for all the women in the intervention group. Nescafe Gold DECAF coffee (5 gm per 100cc
           water containing 5-10 mg of caffeine) will be used for all the women in the control
           group.

        -  Statistical Package:

        -  Data analysis will be performed by Statistical Package for the Social Science (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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled trial
primary purpose: Prevention
masking: Single (Participant)
masking description: All recruited women will be distributed into two groups according to a computer- generated randomization table. The researcher consecutively will open sequentially numbered, opaque, sealed envelopes containing cards with letters either letter (C) or letter (N), Cards with letter (C) will represent the group who will receive the caffeinated coffee and cards with letter (N) will represent the group who will receive the decaffeinated coffee
measure: A change in the number of hours for women to pass flatus for the first time after an elective caesarean section
time frame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass flatus.
description: A change the number of hours for women to pass flatus for the first time after an elective caesarean section
measure: A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section
time frame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. A stethoscope will be used to detect the first intestinal movement every hour after the surgery
description: A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section.
measure: A difference in the number of hours for the women to pass stool after caesarean section.
time frame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass feces.
description: A difference in the number of hours for the women to pass stool after caesarean section.
measure: A difference in the number of the women's hospital stay hours after caesarean section
time frame: calculating the number of the women's hospital stay hours after caesarean section up to 12 weeks
description: A difference in the number of the women's hospital stay hours after caesarean section
measure: Occurrence of postoperative spinal headache
time frame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher with the occurrence, severity and relief of spinal headache during the hospital stay.
description: Occurrence of postoperative spinal headache
arm group label: The intervention group (C group receiving caffeinated coffee)
arm group type: Active Comparator
description: 100cc coffee at 3, 6 and 9 hours after the Cesarean section
arm group label: The control group (N group receiving decaffeinated coffee)
arm group type: Placebo Comparator
description: 100cc decaf coffee at 3, 6, 9 hours after the Cesarean section
intervention type: Dietary Supplement
intervention name: Nescafe Gold ® coffee
description: Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used for all the women in the intervention group.
- patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery.
arm group label: The intervention group (C group receiving caffeinated coffee)
intervention type: Dietary Supplement
intervention name: Nescafe Gold DECAF® coffee
description: Nescafe Gold DECAF coffee (5 gm per 100cc water containing 5-10 mg of caffeine) will be used for all the women in the control group.
the control group will drink 100cc decaffeinated coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery.
arm group label: The control group (N group receiving decaffeinated coffee)
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: AMR NADIM
role: Study Director
affiliation: Ain Shams University
last name: REDA GHANEM
role: Study Director
affiliation: Ain Shams University
last name: MADONNA BENYAMINE
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
citation: Artinyan A, Nunoo-Mensah JW, Balasubramaniam S, Gauderman J, Essani R, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr. Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg. 2008 Jul;32(7):1495-500. doi: 10.1007/s00268-008-9491-2.
PMID: 18305994
citation: Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. 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 Dec;29(12):1527-34. doi: 10.1007/s00384-014-2030-8. Epub 2014 Oct 21.
PMID: 25331030
citation: Bragg D, El-Sharkawy AM, Psaltis E, Maxwell-Armstrong CA, Lobo DN. Postoperative ileus: Recent developments in pathophysiology and management. Clin Nutr. 2015 Jun;34(3):367-76. doi: 10.1016/j.clnu.2015.01.016. Epub 2015 Jan 31.
PMID: 25819420
citation: Brown SR, Cann PA, Read NW. Effect of coffee on distal colon function. Gut. 1990 Apr;31(4):450-3. doi: 10.1136/gut.31.4.450.
PMID: 2338272
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responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Madonna Gamal Garas Benyamine
investigator title: DR. MADONNA GAMAL GARAS BENYAMINE
mesh term: Ileus
sharing ipd: Undecided
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