Gum ChewingPhase 4RCTNCT02533830
Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience
A Phase 4 study testing sugarless gum and traditional management in people with Gum Chewing and Bowel Function, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gum Chewing, Bowel Function
- What is being tested?
- sugarless gum and traditional management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 2 sitesEgypt
- Study dates
- Aug 2015to Jul 2016
- Phase
- Phase 4
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 - 35 Years.
- Spinal Anesthesia.
- Pfannenstiel incision.
Who cannot join
- History of Drug Consumption Especially Opioids.
- Water and Electrolyte Disturbances.
- Pancreatitis.
- Peritonitis.
- History of Abdominal Surgery except Cesarean Section.
- No Willingness to Cooperative.
Show all 13Show fewer
- Intra and Sever Post-Operative Complications.
- Inability to Chew Gum with Drawl.
- Diabetes.
- Pre-eclampsia
- Prolonged Rupture of Membranes.
- Hypothyroidism.
- Muscular and Neurological Disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Mohamed Abdel Aziz El Sharkawy
Cairo
- Recruiting
Mohqmed El Sharkawy
Cairo
Mohmed AA El Sharkawy, M.D., 01221731328, kingdoc82@outlook.com
Dina L Hatem, 01226609129, dinalatif@outlook.com
About this study
Official title: Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience.A Randomized Controlled Trial
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.
Read the 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 .
- Conditions
- Gum Chewing, Bowel Function
- Being tested
- sugarless gum, traditional management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugarless gumBiological
Also called Samara Gum
One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation
traditional managementOther
Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.
| Study group | Role | What they receive |
|---|---|---|
| gum chewing group. | Active comparator | 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 Receives: Biological: sugarless gum |
| Placebo group | Placebo comparator | 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. Receives: Other: traditional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first audible bowel sound in hours
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
Measured: 4 months
Secondary outcomes (1)
patient satisfaction
Change From Baseline in Pain on the 11 point Short Pain Scale (SPS-11)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum ChewingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El-Sharkawy, Kasr El Aini Hospital
- Investigators
- Kasr El Ainy, Study chair, kasr el ainy street,cairo,egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533830
- Sponsor's protocol ID
- KasrELAini hospital
- Acronym
- RCT
- Status last verified
- Aug 2015
- First submitted
- 21 Aug 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience.A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02533830
- Acronym / sponsor ID
- RCT / KasrELAini hospital
- Conditions
- Gum Chewing, Bowel Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 27 Aug 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gum chewing group. | Active comparator | Biological: sugarless gumGroup 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 | Placebo comparator | Other: traditional managementGroup 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 - 35 Years.
- Spinal Anesthesia.
- Pfannenstiel incision.
Key exclusion criteria (13 listed)
- History of Drug Consumption Especially Opioids.
- Water and Electrolyte Disturbances.
- Pancreatitis.
- Peritonitis.
- History of Abdominal Surgery except Cesarean Section.
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 |
|---|---|---|
| sugarless gumAlso: Samara GumOne Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation | Biological | gum chewing group. |
| traditional managementTraditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement. | Other | Placebo group |
Primary outcome
the first audible bowel sound in hours
Time frame: 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
1 secondary outcome
patient satisfaction
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
Related trials for Gum Chewing
Not yet recruitingObservational study
Chewing Pattern Changes Before and After Space Maintainer Placement in Children
Premature Loss of Primary Molars
RecruitingPhase 2/3
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
Preterm Birth, Low Birthweight Neonate
Recruiting
Distraction Methods for Reducing Pain and Fear During Blood Draw in Children
Pain Management, Fear
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Recruiting
Effects of Hard Gum Chewing on Facial Soft Tissue Morphology
Face
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.
Kasr El Ainy study chair
kasr el ainy street,cairo,egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sugarless gum and traditional management in people with Gum Chewing and Bowel Function, run by Kasr El Aini Hospital at 2 sites in Egypt.
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 13 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: status not confirmed, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ab El Sharkawy (00201221731328, kingdoc82@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the first audible bowel sound in hours (time frame: 4 months). 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 1 Feb 2016.