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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN83008008
• Date of registration: 18/02/2010
• Prospective Registration: No
• Primary sponsor: Ain Shams University Hospitals (Egypt)
• Public title: Gum chewing and the return of bowel motility after caesarean section under regional anaesthesia
• Scientific title: Post-operative gum chewing and the return of bowel motility after elective caesarean section under regional anaesthesia: a prospective randomised controlled trial
• Date of first enrolment: 15/02/2010
• Target sample size: 48
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN83008008
• Study type: Interventional
• Study design: Prospective randomised controlled trial (Treatment)

Countries of recruitment

Egypt

Contacts

• Name: Karim Abd-El-Maeboud

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Bowel motility
Digestive System
Bowel motility

Intervention(s)

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)

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

002

Source(s) of Monetary Support

Investigator initiated and funded (Egypt)