NCT03355378

Brief Summary

After major open abdominal surgery, transient paralytic ileus usually follows. It has been suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of inhibitory neurotransmitters from bowel wall associated with bowel manipulation and peritoneal irritation are responsible mechanisms. There have been concerns that early postoperative oral feeding would lead to vomiting with subsequent aspiration pneumonia, anastomotic leakage, and wound dehiscence.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

November 22, 2017

Last Update Submit

July 4, 2018

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • duration of hospital stay

    time of postoperative recovery of gastrointestinal tract

    48 hours

Study Arms (2)

study group

EXPERIMENTAL

gum chewing during spinal anesthesia and early ambulation

Procedure: gum chewing

Control group

NO INTERVENTION

no gum chewing

Interventions

gum chewingPROCEDURE

chewing gum orally for 30 minutes

study group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women is sure of her last menstrual period or documented early pregnancy ultrasound.
  • Women aged 20-35 years.
  • Women with Body mass index18-22 kg/m2.
  • Estimated gestational age is ranging between 37-40 weeks gestation.
  • Accepting to participate in the study.

You may not qualify if:

  • Smoker ≥ 11 cigarettes/day.
  • Caesarean hysterectomy .
  • Surgical management of severe postpartum haemorrhage .
  • History of bowel obstruction , inflammatory bowel disease .
  • Previous abdominal or pelvic radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 28, 2017

Study Start

November 1, 2017

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

EG(1)