Simo Decoction and Gum Chewing for Bowel Activity

NCT ID: NCT02438436

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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simo decoction

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.

Group Type EXPERIMENTAL

simo decoction

Intervention Type DIETARY_SUPPLEMENT

gum chewing

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

Group Type ACTIVE_COMPARATOR

gum chewing

Intervention Type OTHER

empty control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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simo decoction

Intervention Type DIETARY_SUPPLEMENT

gum chewing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jian-Hong Zhong

Guangxi Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Le-Qun Li, MD

Role: STUDY_CHAIR

Guangxi Medical University Cancer Hospital

Locations

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Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 22672009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25524125 (View on PubMed)

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.

Reference Type RESULT
PMID: 26559269 (View on PubMed)

Related Links

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Other Identifiers

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SD/GC-HCC

Identifier Type: -

Identifier Source: org_study_id

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