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

Cesarean Section Complications Clinical Trial

Official title:

The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815877
• Other study ID #: AinShamsU2018455
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: January 12, 2019

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 12, 2019
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• women undergoing caesarean section

• Spinal anaesthesia

• Total surgery time less than 90 minutes

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Caffeine
• Cesarean Section Complications
• Ileus
• Postoperative Ileus

Intervention

Dietary Supplement:
• Nescafe Gold ® coffee
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.
• Nescafe Gold DECAF® coffee
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.

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. — View 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. Review. — View Citation

Brown SR, Cann PA, Read NW. Effect of coffee on distal colon function. Gut. 1990 Apr;31(4):450-3. — View 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. Review. — View 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. — View Citation

Güngördük K, Özdemir IA, Güngördük Ö, Gülseren V, Gokçü 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. — View Citation

Holte K, Kehlet H. Postoperative ileus: progress towards effective management. Drugs. 2002;62(18):2603-15. Review. — View Citation

Müller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Büchler 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. — View 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. Review. — View 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. — View 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. Epub 2006 Oct 17. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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.