NCT03884244

Brief Summary

The authors aimed to evaluate the effects of postoperative gum chewing on laparoscopic gynecological surgery, gastrointestinal function-intestinal mobility and early postoperative recovery. Patients undergoing elective gynecological laparoscopy were randomized. Demographic and characteristic features of the patients were recorded. Operation type, operation and anesthesia information were recorded. Patients underwent a postoperative routine regimen. Starting from the sixth hour, the sugar-free gum was crushed every 15 minutes until the gas was released. Postoperative follow-up was performed routinely. The first bowel movements, first bowel movements and first gas extraction and first decongestation periods were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

March 12, 2019

Last Update Submit

July 17, 2024

Conditions

Keywords

Laparoscopic SurgeryPostoperative Bowel Function

Outcome Measures

Primary Outcomes (1)

  • Postoperative Bowel Functions

    The Effect of Postoperative Chewing Gum on Intestinal Functions after Gynecological Laparoscopic Surgery ; The primary index for the return of GI functions was the first gas removal time. Patient first extraction of gas, recorded in minutes.

    Postoperative first 1440 minutes

Study Arms (2)

taking chewing gum patients

ACTIVE COMPARATOR
Other: chewing gum

no chewing gum

NO INTERVENTION

Interventions

The group who take chewing gum after operation

taking chewing gum patients

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective laparoscopic gynecological surgery.

You may not qualify if:

  • Those who have been operated for malignant reasons,
  • Those who underwent emergency surgery,
  • Who could not chew gum,
  • Who had serious surgical complications (postoperative intraabdominal hemorrhage, infection, peritonitis),
  • Who had a history of gastrointestinal disease,
  • Secondary laparotomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pınar Kadiroğulları

Istanbul, 33403, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Genital Diseases, FemaleIntestinal Pseudo-Obstruction

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesIleusIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 21, 2019

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations