Gynecologic DiseaseNCT06446583
Preoperative Chewing Gum and Postoperative Nausea and Vomiting
A study testing Chewing sugar-free gum in people with Gynecologic Disease, run by Min Suk Chae.
Trial summary
General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend… Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Chewing sugar-free gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 to under 70 years
- Scheduled elective robotic surgery
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II
Who cannot join
- Cases where robotic surgery was planned but suddenly converted to another type of surgery
- Patients with a history of dental damage, dentures, loose or capped teeth, or other unstable dental conditions
- Patients with a history of temporomandibular joint (TMJ) damage or surgery
- Head and neck surgeries
- Emergency surgeries
- Refusal to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Impact of Preoperative Chewing Gum on Postoperative Nausea and Vomiting in Robotic Surgery
General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend hospital stays. Therefore, meticulous perioperative management is crucial.
In recent years, efforts have been made to reduce the burden of surgery, decrease postoperative complications, and promote rapid rehabilitation for a quicker return to daily life. These efforts also aim to reduce healthcare costs by shortening hospital stays and optimizing resources. Various interventions, such as early feeding, early removal of nasogastric tubes, and physical therapy, have been trialed in clinical settings to prevent prolonged bowel inactivity and paralysis. However, due to limited clinical efficacy, these methods are not routinely used.
Recently, many researchers have reported the benefits of chewing gum in enhancing bowel motility and reducing PONV. However, there is limited research on the impact of chewing gum on PONV in robotic surgeries, which are considered less invasive compared to open or laparoscopic surgeries. Furthermore, there is particularly scarce research on the effects of preoperative gum chewing.
- Conditions
- Gynecologic Disease
- Being tested
- Chewing sugar-free gum
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing sugar-free gumOther
Upon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative chewing gum group | Experimental | Upon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded. Receives: Other: Chewing sugar-free gum |
| No preoperative chewing gum group | No intervention | After arriving at the preoperative preparation room, patients wait without chewing gum until they enter the operating room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
nausea and vomiting
Incidence of nausea and vomiting in the post-anesthesia care unit
Measured: One hour after surgery, referring to the period spent in the post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Suk Chae
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Suk Chae, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446583
- Sponsor's protocol ID
- KC24EISI0138
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Impact of Preoperative Chewing Gum on Postoperative Nausea and Vomiting in Robotic Surgery
- ClinicalTrials.gov ID
- NCT06446583
- Acronym / sponsor ID
- KC24EISI0138
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Min Suk ChaeUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend hospital stays. Therefore, meticulous perioperative management is crucial.
In recent years, efforts have been made to reduce the burden of surgery, decrease postoperative complications, and promote rapid rehabilitation for a quicker return to daily life. These efforts also aim to reduce healthcare costs by shortening hospital stays and optimizing resources. Various interventions, such as early feeding, early removal of nasogastric tubes, and physical therapy, have been trialed in clinical settings to prevent prolonged bowel inactivity and paralysis. However, due to limited clinical efficacy, these methods are not routinely used.
Recently, many researchers have reported the benefits of chewing gum in enhancing bowel motility and reducing PONV. However, there is limited research on the impact of chewing gum on PONV in robotic surgeries, which are considered less invasive compared to open or laparoscopic surgeries. Furthermore, there is particularly scarce research on the effects of preoperative gum chewing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative chewing gum group | Experimental | Other: Chewing sugar-free gumUpon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded. |
| No preoperative chewing gum group | No intervention | –After arriving at the preoperative preparation room, patients wait without chewing gum until they enter the operating room. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 19 to under 70 years
- Scheduled elective robotic surgery
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II
Key exclusion criteria (6 listed)
- Cases where robotic surgery was planned but suddenly converted to another type of surgery
- Patients with a history of dental damage, dentures, loose or capped teeth, or other unstable dental conditions
- Patients with a history of temporomandibular joint (TMJ) damage or surgery
- Head and neck surgeries
- Emergency surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing sugar-free gumUpon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded. | Other | Preoperative chewing gum group |
Primary outcome
nausea and vomiting
Time frame: One hour after surgery, referring to the period spent in the post-anesthesia care unit
Incidence of nausea and vomiting in the post-anesthesia care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing sugar-free gum in people with Gynecologic Disease, run by Min Suk Chae.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Suk Chae, MD, PhD (0222586150, shscms@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nausea and vomiting (time frame: One hour after surgery, referring to the period spent in the post-anesthesia care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.