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Simo Decoction and Gum Chewing for Bowel Activity (SD/GC-HCC)

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
simo decoction
gum chewing
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

simo decoction

gum chewing

empty control

Arm Description

Patients will receive simo decoction (10 mL/piece,three times per day) and bilateral tsusanli acupoint injections with vitamin B1 two times per day, starting in the first day after resection until flatus.

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

Outcomes

Primary Outcome Measures

First flatus time
xerostomia

Secondary Outcome Measures

Full Information

First Posted
May 6, 2015
Last Updated
January 27, 2023
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02438436
Brief Title
Simo Decoction and Gum Chewing for Bowel Activity
Acronym
SD/GC-HCC
Official Title
Influence of Simo Decoction Plus Acupuncture and Gum Chewing on Postoperative Bowel Activity After Resection for Patients With HCC
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Abdominal surgery, including hepatic resection for hepatocellular carcinoma (HCC), is inevitably followed by an episode of gastrointestinal hypomotility. A delayed return of gastrointestinal function, defined as postoperative ileus (POI), has a great impact on patient comfort, morbidity and recovery. POI often results in a prolonged hospital stay and contributes significantly to healthcare costs. Some prospective studies have revealed that gum chewing can improve the return of gastrointestinal function after colorectum surgery, gynaecology and obstetrics, and urinary system surgery. Moreover, some retrospective studies also revealed that simo decoction may improve the return of gastrointestinal function after hepatic resection of HCC. Therefore, the present study compared the effect of gum chewing and simo decoction after hepatic resection of HCC on POI, surgical complications, and length of hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
simo decoction
Arm Type
Experimental
Arm Description
Patients will receive simo decoction (10 mL/piece,three times per day) and bilateral tsusanli acupoint injections with vitamin B1 two times per day, starting in the first day after resection until flatus.
Arm Title
gum chewing
Arm Type
Active Comparator
Arm Description
Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
Arm Title
empty control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
simo decoction
Intervention Type
Other
Intervention Name(s)
gum chewing
Primary Outcome Measure Information:
Title
First flatus time
Time Frame
one day
Title
xerostomia
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Underwent open hepatic resection Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Le-Qun Li, MD
Organizational Affiliation
Guangxi Medical University Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22672009
Citation
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.
Results Reference
background
PubMed Identifier
25524125
Citation
van den Heijkant TC, Costes LM, van der Lee DG, Aerts B, Osinga-de Jong M, Rutten HR, Hulsewe KW, de Jonge WJ, Buurman WA, Luyer MD. Randomized clinical trial of the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery. Br J Surg. 2015 Feb;102(3):202-11. doi: 10.1002/bjs.9691. Epub 2014 Dec 18.
Results Reference
background
PubMed Identifier
26559269
Citation
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.
Results Reference
result
Links:
URL
https://journals.lww.com/md-journal/Fulltext/2015/11110/Randomized_Clinical_Trial_Comparing_Efficacy_of.24.aspx
Description
This study is completed.

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Simo Decoction and Gum Chewing for Bowel Activity

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