The Impact of Chewing Gum on Postoperative Bowel Activity and Postoperative Pain After Total Laparoscopic Hysterectomy

November 22, 2021 updated by: ŞENAY DEMİRBAŞ MEYDAN, Kanuni Sultan Suleyman Training and Research Hospital
Surgical interventions, such as restoring the health of patients and eliminating their existing symptoms, the surgical process can have many negative effects on the patient. In order to minimize these complications, the Accelerated Recovery Protocol After Surgery (ERAS) has also found widespread use in obstetric surgery. The ERAS protocol consists of different evidence-based practices at each stage, before, during, and after surgery. Stool and gas extraction, especially colorectal reported that chewing gum has a positive impact on the time/ can be used after pelvic surgical procedures, perioperative care guide contains reported in ERAS protocols, evidence-based, inexpensive, easily applied, and easily tolerated a practice that is emphasized.

Study Overview

Status

Completed

Conditions

Detailed Description

Surgical interventions, such as restoring the health of patients and eliminating their existing symptoms, the surgical process can have many negative effects on the patient. In order to minimize these complications, the Accelerated Recovery Protocol After Surgery (ERAS) has also found widespread use in obstetric surgery. The ERAS protocol consists of different evidence-based practices at each stage, before, during, and after surgery. Stool and gas extraction, especially colorectal reported that chewing gum has a positive impact on the time/ can be used after pelvic surgical procedures, perioperative care guide contains reported in ERAS protocols, evidence-based, inexpensive, easily applied, and easily tolerated a practice that is emphasized. Different studies have been conducted to determine the effect of chewing gum on intestinal peristalsis. Intestinal sounds and defecation of chewing gum after cesarean section surgery. A limited number of studies on patients with total laparoscopic hysterectomy exist on this topic.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Küçükçekmece
      • Istanbul, Küçükçekmece, Turkey, 341303
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Total laparoscopic hysterectomy is the most common type of hysterectomy.,

    • Who is literate,
    • over 18 years old,
    • The body mass index is dec 18.50-24.99 kg/m2,
    • Able to communicate, no language problems.
    • No history of allergies,
    • Who volunteered to participate in the study and received my approval,
    • No complications during the operation,
    • With a patient who is not diagnosed with a mental and psychiatric illness

Exclusion Criteria:

  • Who can not adapt to the treatment process,

    • Developing postoperative complications,
    • Chemotherapy - receiving radiation therapy therapy,
    • With epilepsy disease,
    • With any history of allergies,
    • A history of dental and gum diseases, with difficulty chewing,
    • With a problem of the mucous membrane inside the mouth,
    • Using drugs that can affect bowel function due to systemic diseases,
    • Patients with a mental disability or a perception problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: chewing gum Group
Questions related to surgery and bowel function found in the Participant Information Form it will be filled in. The chewing gum group data will be followed up with the "Follow-up Form- Chewing Gum Group ". Women who make up the gum group, based on the time of arrival in the room 2. per hour, 4. and 6 o'clock. they'll chew gum an hour. Chewing gum based on knowledge of the literature its duration will be limited to 15 minutes, and a new gum will be introduced with each chewing. To all women the same brand will be given unsweetened chewing gum, which is easy to chew, does not contain sorbitol and xylitol. Sorbitol GIS problems in the case of ingestion of gums containing it, while gums containing xylitol are more in order not to ignore the decongestant risk of diarrhea when consumed, sugar-free chewing gum was preferred.
control of consciousness chewing gum listening to bowel sounds assessment of pain
Active Comparator: Control group
Questions related to surgery and bowel function found in the Participant Information Form it will be filled in. The control group data were followed up with the "Follow-up Form-Control Group" will be. Of the women who made up the control group, it was not until the bowel sounds were first heard that bowel sounds will be listened to by the service nurse december 2 hours intervals. The patient has gas-stool by querying the output, it will be saved. Application of analgesics to pain levelsin the case of "Visual Analog Scale" (Visual Analog Scale -Vas) within 15 minutes it will be evaluated with. After the end of the researcher's 8-hour shift, the time of gas extraction and defecation is estimated since it cannot be done, women can set the time of gas extraction and defecation as time/date; they'll record it. Assessment of pain level, first 8. After the time of 16 and 24. in the hours will be made.
control of consciousness listening to bowel sounds assessment of pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the postoperative baseline bowel activity (bowel sounds) at the first 6 hours postoperative pain after total laparoscopic hysterectomy
Time Frame: within postoperative first 6 hours, three times per 2 hours
Time to first detection of postoperative bowel activity will be evaluated by the same healthcare worker via physical examination (oscultation of the four quadrants)
within postoperative first 6 hours, three times per 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Melike Dissiz, Professor, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1111 (Prima Psychiatry internal research fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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