The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section.

NCT03815877 | Completed DMC

• 1 other identifier: AinShamsU2018455
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Ileus; Cesarean Section Complications; Caffeine

Keywords

Caffeine; Postoperative Ileus; Caesarean Section

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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

• 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

  calculating the number of the women's hospital stay hours after caesarean section up to 12 weeks

• 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.

Study Arms (2)

The intervention group (C group receiving caffeinated coffee)

ACTIVE COMPARATOR

100cc coffee at 3, 6 and 9 hours after the Cesarean section

Dietary Supplement: Nescafe Gold ® coffee

The control group (N group receiving decaffeinated coffee)

PLACEBO COMPARATOR

100cc decaf coffee at 3, 6, 9 hours after the Cesarean section

Dietary Supplement: Nescafe Gold DECAF® coffee

Interventions

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.

The intervention group (C group receiving caffeinated 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.

The control group (N group receiving decaffeinated coffee)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women undergoing caesarean section
• Spinal anaesthesia
• Total surgery time less than 90 minutes

You may not qualify if:

• Previous complicated abdominal surgery or caesarean section with extensive adhesions requiring extensive dissection or intestinal manipulation.
• Caesarean section complicated by postpartum hemorrhage or in the women who received misoprostol.
• Intraoperative intestinal complications.
• Intraoperative respiratory complication.
• Chronic intestinal diseases: irritable or inflammatory bowel diseases.
• Chronic diarrhea or constipation.
• Using laxatives pre-operatively.
• Known hypersensitivity to caffeine
• Thyroid or hepatic disease.
• Cardiac arrhythmias

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, 11566, Egypt

Location

Related Publications (15)

• 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 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.

  PMID: 25331030 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.

  PMID: 25819420 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.

  PMID: 2338272 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.

  PMID: 27073081 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.

  PMID: 23906657 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.

  PMID: 27780709 BACKGROUND

• Holte K, Kehlet H. Postoperative ileus: progress towards effective management. Drugs. 2002;62(18):2603-15. doi: 10.2165/00003495-200262180-00004.

  PMID: 12466000 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.

  PMID: 22987303 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.

  PMID: 29202396 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.

  PMID: 11298633 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.

  PMID: 17042776 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.

  PMID: 17304396 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.

  PMID: 21607794 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.

  PMID: 23838894 BACKGROUND

Study Officials

• AMR NADIM

  Ain Shams University

  STUDY DIRECTOR

• REDA GHANEM

  Ain Shams University

  STUDY DIRECTOR

• MADONNA BENYAMINE

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR. MADONNA GAMAL GARAS BENYAMINE

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2019
• Study Start: January 17, 2018
• Primary Completion: December 10, 2018
• Study Completion: January 12, 2019
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

EG (1)