Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience

Phase 4

• Conditions: Gum Chewing; Bowel Function
• Interventions: Biological: sugarless gum; Other: traditional management

• Registration Number: NCT02533830
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

The aim of the present study was to evaluate the effect of chewing gum on the recovery of bowel function after cesarean section in women.

Detailed Description

This study Will Be conducted on 162 Patients Undergoing caesarean section in The Obstetrics \& Gynecology Department "kasr el ainy teaching hospital".

Methods:

Women Were Randomized into Two Groups: Group A (81 Women) Who Received One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation , Group B (81 Women) had Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Each Women in Both Groups Was Examined Abdominal Using A Stethoscope Detect The Intestinal Movement Every 4 Hours And Asked to Report Immediately The Time of Either Passing Flatus or stool .

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

1. Age between 18 - 35 Years.
2. Spinal Anesthesia.
3. Pfannenstiel incision.

Exclusion Criteria

1. History of Drug Consumption Especially Opioids.
2. Water and Electrolyte Disturbances.
3. Pancreatitis.
4. Peritonitis.
5. History of Abdominal Surgery except Cesarean Section.
6. No Willingness to Cooperative.
7. Intra and Sever Post-Operative Complications.
8. Inability to Chew Gum with Drawl.
9. Diabetes.
10. Pre-eclampsia
11. Prolonged Rupture of Membranes.
12. Hypothyroidism.
13. Muscular and Neurological Disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gum chewing group.	sugarless gum	Group A (81 Women) Who Received One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation
Placebo group	traditional management	Group B (81 Women) had Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Primary Outcome Measures

Name	Time	Method
the first audible bowel sound in hours	4 months	The First Bowel Sounds (Hours) The First Passage of Flatus (Hours) The First Defection (Hours) The First Bowel Sounds (Hours) The First Passage of Flatus (Hours) The First Defection (Hours) the first auscultation of regular bowel sounds in hours

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	4 months	Change From Baseline in Pain on the 11 point Short Pain Scale (SPS-11)

Trial Locations

Locations (2)

Mohqmed El Sharkawy; 🇪🇬 Cairo, Egypt

Mohamed Abdel Aziz El Sharkawy; 🇪🇬 Cairo, Egypt