NCT05135416

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

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

Same day

First QC Date

September 29, 2021

Last Update Submit

November 22, 2021

Conditions

Keywords

PainTotal Laparoscopic Hysterectomy SurgeryBowel FunctionsChewing GumNursing

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 COMPARATOR

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.

Procedure: chewing gum Group

Control group

ACTIVE COMPARATOR

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.

Procedure: Control group

Interventions

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

chewing gum Group
Control groupPROCEDURE

control of consciousness listening to bowel sounds assessment of pain

Control group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Melike Dissiz, Professor

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: crossover assignment
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

Locations