NCT04970732

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

July 1, 2021

Last Update Submit

July 20, 2021

Conditions

Lumbar Spondylosis

Keywords

Lumbar degenerate diseasesPostoperative managementAbdominal distension

Outcome Measures

Primary Outcomes (4)

  • Physical examination

    Number of bowel sounds

    After surgery to discharge, an average of 4 days

  • Time points

    First anal exhaust time, first defecation time

    After surgery to discharge, an average of 4 days

  • Medication

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

    After surgery to discharge, an average of 4 days

  • Incidence of abdominal distension

    Incidence of abdominal distension

    After surgery to discharge, an average of 4 days

Secondary Outcomes (1)

  • Oral comfort

    After surgery to discharge, an average of 4 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group received routine nursing after surgery.

Interventions

Gum chewingPROCEDURE

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

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 21, 2021

Study Start

June 14, 2018

Primary Completion

July 1, 2020

Study Completion

July 30, 2020

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)