Effect of Chewing Gum on Abdominal Distension in Patients After Lumbar Spine Surgery

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04970732
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.5
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

According to chewing gum can promote the recovery of gastrointestinal function, it is used as an intervention measure for patients after lumbar surgery to evaluate the effect of chewing gum on improving abdominal distension of patients after lumbar surgery, so as to provide basis for the application and promotion of chewing gum in lumbar postoperative nursing

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spondylosis	Procedure: Gum chewing	N/A

Detailed Description

In this study, the patients after lumbar surgery were given chewing gum after anesthesia. The exhaust time, defecation time and the incidence of abdominal distension of the two groups were compared, and the significance of chewing gum in improving abdominal distension after lumbar surgery was discussed

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Study to Evaluate the Effectiveness of Chewing Gum in Improving Abdominal Distension After Lumbar Spine Surgery
• Actual Study Start Date: Jun 14, 2018
• Actual Primary Completion Date: Jul 1, 2020
• Actual Study Completion Date: Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group The patients in the experimental group returned to the ward for general anesthesia, started to wake up for 2 hours, chewed xylitol gum, and the professional nurses distributed it on time every 2 hours on the operation day, then 3 times / day, 15-20 minutes / time, 2 tablets / time. Body position: lateral position. The first anal exhaust stop chewing, normal sleep at night (8 p.m.), do not chew gum. Gum waste must be identified	Procedure: Gum chewing; The patients in the experimental group returned to the ward for general anesthesia, started to wake up for 2 hours, chewed xylitol gum, and the professional nurses distributed it on time every 2 hours on the operation day, then 3 times / day, 15-20 minutes / time, 2 tablets / time. Body position: lateral position. The first anal exhaust stop chewing, normal sleep at night (8 p.m.), do not chew gum. Gum waste must be identified
No Intervention: Control group The control group received routine nursing after surgery.

Outcome Measures

Primary Outcome Measures

1. Physical examination [After surgery to discharge, an average of 4 days]

   Number of bowel sounds

2. Time points [After surgery to discharge, an average of 4 days]

   First anal exhaust time, first defecation time

3. Medication [After surgery to discharge, an average of 4 days]

   Whether the medication for exhaust and defecation is used. If used, what kind of medicine and the dosage of the medicine.

4. Incidence of abdominal distension [After surgery to discharge, an average of 4 days]

   Incidence of abdominal distension

Secondary Outcome Measures

1. Oral comfort [After surgery to discharge, an average of 4 days]

   Whether the oral comfort is applied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subjects aged 18 years or above were able to chew together;

• Good at listening, speaking, reading and writing;

• Lumbar degenerative disease was definitely diagnosed;

• General anesthesia was used;

• Methods: posterior lumbar decompression, bone graft fusion and internal fixation;

• No history of gum allergy;

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04970732
• Other Study ID Numbers: M2018051
• First Posted: Jul 21, 2021
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: Lumbar degenerate diseases; Postoperative management; Abdominal distension
• Additional relevant MeSH terms: Spondylosis; Dilatation, Pathologic

Study Results

No Results Posted as of Jul 21, 2021