Preoperative Chewing Gum and Postoperative Nausea and Vomiting

Gynecologic Disease Clinical Trial

Official title:

Study on the Impact of Preoperative Chewing Gum on Postoperative Nausea and Vomiting in Robotic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446583
• Other study ID #: KC24EISI0138
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease
• Postoperative Nausea and Vomiting
• Vomiting

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