The Impact of Chewing Gum on Postoperative Bowel Activity and Postoperative Pain After Total Laparoscopic Hysterectomy
1 other identifier
interventional
92
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Sep 2021
1 active site
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
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 29, 2021
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedNovember 26, 2021
November 1, 2021
Same day
September 29, 2021
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of the postoperative baseline bowel activity (bowel sounds) at the first 6 hours postoperative pain after total laparoscopic hysterectomy
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
Study Arms (2)
chewing gum Group
ACTIVE COMPARATORQuestions 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 group
ACTIVE COMPARATORQuestions 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.
Interventions
control of consciousness chewing gum listening to bowel sounds assessment of pain
control of consciousness listening to bowel sounds assessment of pain
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Küçükçekmece, 341303, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Melike Dissiz, Professor
Saglik Bilimleri Universitesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 29, 2021
First Posted
November 26, 2021
Study Start
September 1, 2021
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
November 26, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share