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

NCT ID: NCT05135416

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pain Total Laparoscopic Hysterectomy Surgery Bowel Functions Chewing Gum Nursing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

crossover assignment
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

chewing gum Group

Intervention Type PROCEDURE

control of consciousness chewing gum listening to bowel sounds assessment of pain

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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type PROCEDURE

control of consciousness listening to bowel sounds assessment of pain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

chewing gum Group

control of consciousness chewing gum listening to bowel sounds assessment of pain

Intervention Type PROCEDURE

Control group

control of consciousness listening to bowel sounds assessment of pain

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ŞENAY DEMİRBAŞ MEYDAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melike Dissiz, Professor

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Küçükçekmece, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1111

Identifier Type: -

Identifier Source: org_study_id