Trial Outcomes & Findings for Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients (NCT NCT01583452)

Results Overview

The time between the end of surgery and hospital discharge, measured in hours

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

End of surgery to hospital discharge (from 4 to 7 days)

Results posted on

2015-07-23

Participant Flow

Our study included 5-18 years old patients with gastrointestinal surgery from two institutions (Hospital San José Tec de Monterrey and Hospital Regional Materno Infantil); during April to August 2012. However, because the most common diagnosis in this group of age was appendicitis, only patients with this condition were included at the end.

Initially our study was focused on patients who had gastrointestinal surgery, however, the main diagnosis of our population of interest was appendicitis; and those children with other diagnosis did not meet the criteria for including them in the study. This way, our final population was children who underwent open or laparoscopic appendectomy.

Participant milestones

Participant milestones
Measure	Chewing Gum Group Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care. Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus	No Intervention By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
Overall Study STARTED	21	20
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chewing Gum Group n=21 Participants Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care. Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus	No Intervention n=20 Participants By observing the clinical evolution of the participants not given chewing gum as prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.	Total n=41 Participants Total of all reporting groups
Age, Continuous	9.5 years n=5 Participants	8.6 years n=7 Participants	9.2 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Mexico	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: End of surgery to hospital discharge (from 4 to 7 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

The time between the end of surgery and hospital discharge, measured in hours

Outcome measures

Outcome measures
Measure	Chewing Gum Group n=21 Participants The time between the end of the surgery and the discharge of the patients, measured in hours.	Control Group n=20 Participants The time between the end of surgery and the discharge of the patient measured in hours.
Post-Operative Hospital Stay	79.93 hours Standard Deviation 50.76	72.94 hours Standard Deviation 28.33

SECONDARY outcome

Timeframe: End of surgery to first flatus (from 1 to 3 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

The time between the end of surgery and the moment in which the patient passes first flatus

Outcome measures

Outcome measures
Measure	Chewing Gum Group n=21 Participants The time between the end of the surgery and the discharge of the patients, measured in hours.	Control Group n=20 Participants The time between the end of surgery and the discharge of the patient measured in hours.
Time to First Flatus	17.18 hours Standard Deviation 8.18	24.37 hours Standard Deviation 1.53

SECONDARY outcome

Timeframe: End of surgery to first bowel motion (from 1 to 7 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

The time between the end of surgery and the moment in which the patient presents first bowel movement.

Outcome measures

Outcome measures
Measure	Chewing Gum Group n=21 Participants The time between the end of the surgery and the discharge of the patients, measured in hours.	Control Group n=20 Participants The time between the end of surgery and the discharge of the patient measured in hours.
Time to First Bowel Movement	29.91 hours Standard Deviation 21.27	34.5 hours Standard Deviation 22.78

SECONDARY outcome

Timeframe: End of surgery to oral intake tolerance (from 1 to 3 days)

Population: Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.

The time between the end of surgery to the moment in which the patient can tolerate the intake of fluids or any type of food.

Outcome measures

Outcome measures
Measure	Chewing Gum Group n=21 Participants The time between the end of the surgery and the discharge of the patients, measured in hours.	Control Group n=20 Participants The time between the end of surgery and the discharge of the patient measured in hours.
Time to Tolerate Feedings (Oral Intake)	31.21 hours Standard Deviation 25.46	27.04 hours Standard Deviation 15.51

Adverse Events

Chewing Gum Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chewing Gum Group n=21 participants at risk Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care. Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus	No Intervention n=20 participants at risk By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
Gastrointestinal disorders Swallowing of chewing gum	4.8% 1/21 • Number of events 1 • During the 5 months in which data was collected One patient accidentally swallowed the gum without any clinical signs or complications, however with risk of intestinal obstruction.	0.00% 0/20 • During the 5 months in which data was collected One patient accidentally swallowed the gum without any clinical signs or complications, however with risk of intestinal obstruction.

Additional Information

Gabriela López Jaimez

ITESM - Pediatrics Division

Phone: +527211476044

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place