NCT02649153

Brief Summary

Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. One third of the study population will receive smoked plum, one third with chewing gum, and the last will act as empty control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
5 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2.5 years

First QC Date

January 5, 2016

Last Update Submit

January 22, 2024

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to first peristalsis

    3 days

Study Arms (3)

smoked plum

EXPERIMENTAL

Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus.

Drug: smoked plum

gum chewing

ACTIVE COMPARATOR

Patients will receive gum chewing (three times per day) in the first day after resection until flatus.

Drug: gum chewing

empty control

NO INTERVENTION

This group patients will not receive gum chewing or smoked plum.

Interventions

smoked plumDRUG

Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus

smoked plum
gum chewingDRUG

Patients will receive gum chewing (three times per day) in the first day after resection until flatus.

gum chewing

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Underwent open hepatic resection
  • Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients

You may not qualify if:

  • Previously underwent exploratory laparotomy
  • Laparoscopic surgery
  • Known Central Nervous System tumors including metastatic brain disease
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Tumor of Guangxi University

Nanning, Guangxi, 5350021, China

Location

Related Publications (2)

  • You XM, Mo XS, Ma L, Zhong JH, Qin HG, Lu Z, Xiang BD, Wu FX, Zhao XH, Tang J, Pang YH, Chen J, Li LQ. Randomized Clinical Trial Comparing Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Patients With Hepatocellular Carcinoma After Hepatectomy. Medicine (Baltimore). 2015 Nov;94(45):e1968. doi: 10.1097/MD.0000000000001968.

    PMID: 26559269RESULT

  • Jang SY, Ju EY, Kim DE, Kim JH, Kim YH, Son M, Jang M, Jeong JH, Kim KS. First flatus time and xerostomia associated with gum-chewing after liver resection. J Clin Nurs. 2012 Aug;21(15-16):2188-92. doi: 10.1111/j.1365-2702.2012.04132.x. Epub 2012 Jun 2.

    PMID: 22672009RESULT

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Le-Qun Li, MD

    Affiliated Tumor of Guangxi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

January 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Locations

CN(1)