The Effect of Gum Chewing on Bowel Function After Cesarean Section

Efficacy and Effectiveness of Gum Chewing on Bowel Function After Cesarean Section: a Randomized Controlled Trial

This study is a randomised controlled trial that included 150 pregnant women undergoing cesarean in Sisli Ethal Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey. It was carried out in the period from October 1, 2015 to December 31, 2015. After operation, the participants are going to randomly assigned into two groups by using cards. The patients are going to randomized into two groups by using a sealed enveloped system.The patients in the study group, will chew one sugar less gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.

Study Overview

• Status: Completed
• Conditions: Splinter of Gum
• Intervention / Treatment: Other: chew gum

Detailed Description

For elective cases, all participants are going to given nothing by mouth since midnight before surgery, and all operations are going to perform in the morning. For those who had emergency cesarean section, nothing is going to given per oral for at least 4 hours before the start of the operation. Operation data is going to recorded including surgical setting, type of cesarean section, previous surgery, adhesion and operation time.

After operation, the participants are going to randomly assigned into two groups by using cards. The patients are going to randomized into two groups by using a sealed enveloped system. A blue card and an orange card are going to sealed in separate envelopes. Blue card means patients will chewgum.

The patients in the study group, will chew one sugar less gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. Both patient groups will be mobilized in postoperative 6 hour and 8 hour after the operation, juicy food will be given. It will be introduced to solid foods after bowel movements and gas output occurs. All patients postoperatively 4, 6, 8, 10, 12, 24 and 48 hours will be examined and bowel sounds will be oscult. Gas evolution is still not, enema will be applied. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Marmara
    • Istanbul, Marmara, Turkey, 34100
      • Sisli Etfal Research and Training hospital, Obstetrics and gynecology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. pregnant women who is at least 18 years of age
2. pregnant women whose body mass index is under 35
3. pregnant women who is going to have cesarean section.

Exclusion Criteria:

1. cesarean hysterectomy,
2. surgical management of severe postpartum hemorrhage
3. previous bowel surgery
4. women with history of drug consumption,especially opioids
5. water and electrolyte disturbances
6. pancreatitis or peritonitis
7. inability to chew gum
8. diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders
9. postoperative admission to intensive care unit
10. history of abdominal surgery except cesarean section
11. history of postoperative ileus
12. patients with drains

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: postoperative chew gum; The patients in the study group will chew one sugarless gum for 30 minutes in postoperative 3., 5. and 7. hours.	Other: chew gum; The patients in the study group,will chew one sugarless gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. Both patient groups will be mobilized in postoperative 6 hour and 8 hour after the operation, juicy food will be given. It will be introduced to solid foods after bowel movements and gas output occurs. All patients postoperatively 4, 6,8,10., 12., 24 and 48 hours will be examined and bowel sounds will be oscult. Gas evolution is still not, enema will be applied. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.; Other Names: postoperative chew gum
Placebo Comparator: without postoperative chew gum; The control group will be followed without chew gum.	Other: chew gum; The patients in the study group,will chew one sugarless gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. Both patient groups will be mobilized in postoperative 6 hour and 8 hour after the operation, juicy food will be given. It will be introduced to solid foods after bowel movements and gas output occurs. All patients postoperatively 4, 6,8,10., 12., 24 and 48 hours will be examined and bowel sounds will be oscult. Gas evolution is still not, enema will be applied. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.; Other Names: postoperative chew gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative time to return to active bowel movements	The investigators are going to examine all patients postoperatively 4, 6,8,10., 12., 24 and 48 hours and oscult the bowel sounds. Also all patients are going to note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.	up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative infection rates and early discharge	Postoperative ileus and general surgery consultation were recorded. After discharge, all patients were called post-op sixth day control.	up to 48 hours

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: Fatma YAZICI YILMAZ, Sisli Etfal; Study Director: Begüm AYDOGAN, Sisli Etfal

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 28, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: cesarean section; chew gum; bowel movements
• Other Study ID Numbers: 787