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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:
Intervention:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The intervention group (C group receiving caffeinated coffee) | Active Comparator | 100cc coffee at 3, 6 and 9 hours after the Cesarean section |
|
| The control group (N group receiving decaffeinated coffee) | Placebo Comparator | 100cc decaf coffee at 3, 6, 9 hours after the Cesarean section |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nescafe Gold ® coffee | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| A change in the number of hours for women to pass flatus for the first time after an elective caesarean section | A change the number of hours for women to pass flatus for the first time after an elective caesarean section | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AMR NADIM | Ain Shams University | Study Director |
| REDA GHANEM | Ain Shams University | Study Director |
| MADONNA BENYAMINE | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18305994 | Background | 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. | |
| 25331030 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2018 | Jan 23, 2019 | Prot_SAP_000.pdf |
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A randomized controlled trial
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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
|
| Nescafe Gold DECAF® coffee | Dietary Supplement | 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. |
|
| A difference in the number of hours for the women to pass stool after caesarean section. | A difference in the number of hours for the women to pass stool after caesarean section. | 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. |
| A difference in the number of the women's hospital stay hours after caesarean section | A difference in the number of the women's hospital stay hours after caesarean section | calculating the number of the women's hospital stay hours after caesarean section up to 12 weeks |
| Occurrence of postoperative spinal headache | Occurrence of postoperative spinal headache | 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. |
| 25819420 | Background | 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. |
| 2338272 | Background | 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. |
| 27073081 | Background | 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. |
| 23906657 | Background | 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. |
| 27780709 | Background | 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. |
| 12466000 | Background | Holte K, Kehlet H. Postoperative ileus: progress towards effective management. Drugs. 2002;62(18):2603-15. doi: 10.2165/00003495-200262180-00004. |
| 22987303 | Background | 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. |
| 29202396 | Background | 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. |
| 11298633 | Background | 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. |
| 17042776 | Background | 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. |
| 17304396 | Background | 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. |
| 21607794 | Background | 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. |
| 23838894 | Background | 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. |