Simo Decoction and Gum Chewing for Bowel Activity

Hepatocellular Carcinoma Clinical Trial

— SD/GC-HCC  

Official title:

Influence of Simo Decoction Plus Acupuncture and Gum Chewing on Postoperative Bowel Activity After Resection for Patients With HCC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438436
• Other study ID #: SD/GC-HCC
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2023
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Dietary Supplement:
• simo decoction

Other:
• gum chewing

Locations

Country	Name	City	State
China	Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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 Hepatocellul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First flatus time		one day
Primary	xerostomia		one day

External Links

•   This study is completed.