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Postoperative Chewing Gum and Gynecological Laparoscopic Surgery

Primary Purpose

Gynecologic Disease, Postoperative Ileus, Paralytic Ileus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
chewing gum
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Disease focused on measuring Laparoscopic Surgery, Postoperative Bowel Function

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective laparoscopic gynecological surgery.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Pınar Kadiroğulları

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

taking chewing gum patients

no chewing gum

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2019
Last Updated
March 19, 2019
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03884244
Brief Title
Postoperative Chewing Gum and Gynecological Laparoscopic Surgery
Official Title
The Effect of Postoperative Chewing Gum on Intestinal Functions After Gynecological Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The team of the research team of the research team will listen and record the bowel sounds of the patients, using a stethoscope every two hours starting from the postoperative 3rd hour until the first bowel sounds are heard in each patient. Patients who were able to tolerate patients starting from the 8th hour after the surgery were allowed for mobilization. Also, they were allowed to take fluid regimen from the postoperative 12th hour. Patient satisfaction was evaluated by using visual analogue scale (VAS) on the day of discharge on chewing postoperative. The primary index for the return of GI functions was the first gas removal time. Secondary index was the time of first bowel sound, the first time of admission, hospitalization time and the presence of postoperative ileus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease, Postoperative Ileus, Paralytic Ileus
Keywords
Laparoscopic Surgery, Postoperative Bowel Function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
taking chewing gum patients
Arm Type
Active Comparator
Arm Title
no chewing gum
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
chewing gum
Intervention Description
The group who take chewing gum after operation
Primary Outcome Measure Information:
Title
Postoperative Bowel Functions
Description
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.
Time Frame
Postoperative first 1440 minutes

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective laparoscopic gynecological surgery. Exclusion Criteria: 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.
Facility Information:
Facility Name
Pınar Kadiroğulları
City
Istanbul
ZIP/Postal Code
33403
Country
Turkey

12. IPD Sharing Statement

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Postoperative Chewing Gum and Gynecological Laparoscopic Surgery

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