The Effect of Gum Chewing on Bowel Function After Cesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Splinter of Gum

Intervention / Treatment
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* Other: chew gum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women who is at least 18 years of age pregnant women whose body mass index is under 35 pregnant women who is going to have cesarean section. Exclusion Criteria: cesarean hysterectomy, surgical management of severe postpartum hemorrhage previous bowel surgery women with history of drug consumption,especially opioids water and electrolyte disturbances pancreatitis or peritonitis inability to chew gum diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders postoperative admission to intensive care unit history of abdominal surgery except cesarean section history of postoperative ileus patients with drains

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: postoperative chew gum<br>The patients in the study group will chew one sugarless gum for 30 minutes in postoperative 3., 5. and 7. hours. | Other: chew gum<br>* 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.<br>* Other names: postoperative chew gum;|
| Placebo Comparator: without postoperative chew gum<br>The control group will be followed without chew gum. | Other: chew gum<br>* 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.<br>* Other names: postoperative chew gum;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chew gum, bowel movements, cesarean section