Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
002
Study information
Scientific title
Post-operative gum chewing and the return of bowel motility after elective caesarean section under regional anaesthesia: a prospective randomised controlled trial
Acronym
Study hypothesis
In a recent study, gum chewing - as a form of sham feeding - after caesarean section (CS) under general anaesthesia was found to be safe, well tolerated, and associated with rapid resumption of intestinal motility and shorter hospital stay. In developed countries, CS is mostly performed under regional anaesthesia, and the numbers of such cases are increasing in our country. So, the aim of the present study is to investigate the effect of gum chewing on the return of bowel motility after elective caesarean section under regional anaesthesia.
Ethics approval
Ethics & Research Committee of OB GYN Department, Faculty of Medicine, Ain Shams University, approved on the 22nd December 2009
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Professor Karim Abd-El-Maeboud at kabdelmaeboud@yahoo.com to request a patient information sheet
Condition
Bowel motility
Intervention
Following CS, patients will be randomised to two groups:
Group 1: 24 patients will receive one stick of sugarless non-sweetened gum (Samarah Foods, Cairo, Egypt) for 15 minutes every two hours after surgery until the passage of flatus or bowel movement.
Group 2: 24 patients will receive traditional post-operative management, with oral intake of clear fluids and soft foods allowed after the passage of flatus and regular diet after bowel movement.
Total duration of treatment: about 24 hours (passage of flatus or motion) Total duration of follow-up: 1 week (first few days in hospital and by the end of first post-operative week in outpatient clinic)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
With the time of end of surgery designated as zero hour, efficacy of gum chewing will be assessed based on shortened time interval to first hearing of normal intestinal sounds, to the first passage of flatus, to the first bowel movement, and to the discharge from the hospital.
Secondary outcome measures
1. Recording of post-operative tolerance of gum chewing and post-operative complications, including febrile morbidity (temperature greater than 38ºC on two occasions 6 hours apart), re-operation, blood transfusion, post-operative ileus, and hospital readmission
2. Occurrence of mild ileus symptoms (vomiting or abdominal distension felt by the patient and seen on examination) or post-operative paralytic ileus, defined as a group of manifestations persisting longer than 24 hours or requiring nasogastric tube placement. These manifestations include absent or hypoactive bowel sounds, non-passage of flatus or bowel movement, abdominal distension, more than three episodes of vomiting, with or without generalised crampy abdominal pain.
Overall trial start date
15/02/2010
Overall trial end date
15/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Females aged 16 - 45 years
2. Set for planned elective caesarean section under regional anaesthesia
3. Written and signed informed consent by the patient to participate in the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
48
Participant exclusion criteria
1. Operation not to be done in the morning session
2. Patients with extensive lysis of adhesions of the bowel during CS
3. Patients undergoing caesarean hysterectomy or other extensive intra-abdominal surgery as a result of operative complication
4. Patients with severe post-operative haemorrhage or other post-operative complications requiring emergency interventions
Recruitment start date
15/02/2010
Recruitment end date
15/04/2010
Locations
Countries of recruitment
Egypt
Trial participating centre
2 Mobarak Str., Off Asmaa Fahmy
Cairo
11341
Egypt
Sponsor information
Organisation
Ain Shams University Hospitals (Egypt)
Sponsor details
Obstetrics & Gynaecology Department
Abbassia
Cairo
-
Egypt
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Egypt)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary