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

Primary Purpose

Lumbar Spondylosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gum chewing
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spondylosis focused on measuring Lumbar degenerate diseases, Postoperative management, Abdominal distension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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

The control group received routine nursing after surgery.

Outcomes

Primary Outcome Measures

Physical examination
Number of bowel sounds
Time points
First anal exhaust time, first defecation time
Medication
Whether the medication for exhaust and defecation is used. If used, what kind of medicine and the dosage of the medicine.
Incidence of abdominal distension
Incidence of abdominal distension

Secondary Outcome Measures

Oral comfort
Whether the oral comfort is applied.

Full Information

First Posted
July 1, 2021
Last Updated
July 20, 2021
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04970732
Brief Title
Effect of Chewing Gum on Abdominal Distension in Patients After Lumbar Spine Surgery
Official Title
A Randomized Controlled Study to Evaluate the Effectiveness of Chewing Gum in Improving Abdominal Distension After Lumbar Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylosis
Keywords
Lumbar degenerate diseases, Postoperative management, Abdominal distension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received routine nursing after surgery.
Intervention Type
Procedure
Intervention Name(s)
Gum chewing
Intervention Description
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
Primary Outcome Measure Information:
Title
Physical examination
Description
Number of bowel sounds
Time Frame
After surgery to discharge, an average of 4 days
Title
Time points
Description
First anal exhaust time, first defecation time
Time Frame
After surgery to discharge, an average of 4 days
Title
Medication
Description
Whether the medication for exhaust and defecation is used. If used, what kind of medicine and the dosage of the medicine.
Time Frame
After surgery to discharge, an average of 4 days
Title
Incidence of abdominal distension
Description
Incidence of abdominal distension
Time Frame
After surgery to discharge, an average of 4 days
Secondary Outcome Measure Information:
Title
Oral comfort
Description
Whether the oral comfort is applied.
Time Frame
After surgery to discharge, an average of 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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