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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06446583
Other study ID # KC24EISI0138
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Seoul St. Mary's Hospital
Contact Min Suk Chae, MD, PhD
Phone 0222586150
Email shscms@catholic.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 92
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria: 1. Adult patients aged 19 to under 70 years 2. Scheduled elective robotic surgery 3. American Society of Anesthesiologists (ASA) Physical Status Classification I or II Exclusion Criteria: 1. Cases where robotic surgery was planned but suddenly converted to another type of surgery 2. Patients with a history of dental damage, dentures, loose or capped teeth, or other unstable dental conditions 3. Patients with a history of temporomandibular joint (TMJ) damage or surgery 4. Head and neck surgeries 5. Emergency surgeries 6. Refusal to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chewing sugar-free gum
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Min Suk Chae

Outcome

Type Measure Description Time frame Safety issue
Primary nausea and vomiting Incidence of nausea and vomiting in the post-anesthesia care unit One hour after surgery, referring to the period spent in the post-anesthesia care unit
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