Splinter of GumNCT02497794
The Effect of Gum Chewing on Bowel Function After Cesarean Section
A study testing chew gum in people with Splinter of Gum, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Splinter of Gum
- What is being tested?
- chew gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Etfal Research and Training hospital, Obstetrics and gynecology department
Istanbul, Marmara, 34100
About this study
Official title: 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.
Read the 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.
- Conditions
- Splinter of Gum
- Being tested
- chew gum
- Keywords
- chew gum, bowel movements, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chew gumOther
Also called postoperative 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.
| Study group | Role | What they receive |
|---|---|---|
| postoperative chew gum | Active comparator | The patients in the study group will chew one sugarless gum for 30 minutes in postoperative 3., 5. and 7. hours. Receives: Other: chew gum |
| without postoperative chew gum | Placebo comparator | The control group will be followed without chew gum. Receives: Other: chew gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 hours
Secondary outcomes (1)
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.
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splinter of GumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı YENIGUL, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Fatma YAZICI YILMAZ, Principal investigator, Sisli etfalBegüm AYDOGAN, Study director, Sisli etfal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497794
- Sponsor's protocol ID
- 787
- Status last verified
- Aug 2017
- First submitted
- 28 Jun 2015
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Effectiveness of Gum Chewing on Bowel Function After Cesarean Section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02497794
- Acronym / sponsor ID
- 787
- Conditions
- Splinter of Gum
- Keywords
- chew gum, bowel movements, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative chew gum | Active comparator | Other: chew gumThe patients in the study group will chew one sugarless gum for 30 minutes in postoperative 3., 5. and 7. hours. |
| without postoperative chew gum | Placebo comparator | Other: chew gumThe control group will be followed without chew gum. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- cesarean hysterectomy,
- surgical management of severe postpartum hemorrhage
- previous bowel surgery
- women with history of drug consumption,especially opioids
- water and electrolyte disturbances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chew gumAlso: postoperative chew gumThe 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 | postoperative chew gum, without postoperative chew gum |
Primary outcome
Postoperative time to return to active bowel movements
Time frame: up to 48 hours
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.
1 secondary outcome
Postoperative infection rates and early discharge
Time frame: up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma YAZICI YILMAZ principal investigator
Sisli etfal
Begüm AYDOGAN study director
Sisli etfal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chew gum in people with Splinter of Gum, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative time to return to active bowel movements (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.