Condition category
Digestive System
Date applied
02/02/2010
Date assigned
18/02/2010
Last edited
18/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karim Abd-El-Maeboud

ORCID ID

Contact details

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

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

http://med.shams.edu.eg/maternity/

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

Publication citations

Additional files

Editorial Notes