Gum chewing and the return of bowel motility after caesarean section under regional anaesthesia

ISRCTN ISRCTN83008008
DOI https://doi.org/10.1186/ISRCTN83008008
Secondary identifying numbers 002
Submission date
02/02/2010
Registration date
18/02/2010
Last edited
18/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Karim Abd-El-Maeboud
Scientific

2 Mobarak Str., Off Asmaa Fahmy
Ard El-Golf
Heliopolis
Cairo
11341
Egypt

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please contact Professor Karim Abd-El-Maeboud at kabdelmaeboud@yahoo.com to request a patient information sheet
Scientific titlePost-operative gum chewing and the return of bowel motility after elective caesarean section under regional anaesthesia: a prospective randomised controlled trial
Study objectivesIn 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(s)Ethics & Research Committee of OB GYN Department, Faculty of Medicine, Ain Shams University, approved on the 22nd December 2009
Health condition(s) or problem(s) studiedBowel motility
InterventionFollowing 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 typeOther
Primary outcome measureWith 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 measures1. 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 study start date15/02/2010
Completion date15/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants48
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment15/02/2010
Date of final enrolment15/04/2010

Locations

Countries of recruitment

  • Egypt

Study participating centre

2 Mobarak Str., Off Asmaa Fahmy
Cairo
11341
Egypt

Sponsor information

Ain Shams University Hospitals (Egypt)
Hospital/treatment centre

Obstetrics & Gynaecology Department
Abbassia
Cairo
-
Egypt

Website http://med.shams.edu.eg/maternity/
ROR logo "ROR" https://ror.org/00cb9w016

Funders

Funder type

Other

Investigator initiated and funded (Egypt)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan