- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02438436
Simo Decoction and Gum Chewing for Bowel Activity (SD/GC-HCC)
Influence of Simo Decoction Plus Acupuncture and Gum Chewing on Postoperative Bowel Activity After Resection for Patients With HCC
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Guangxi
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Nanning, Guangxi, China, 530021
- Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Active Comparator: gum chewing
Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
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No Intervention: empty control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
First flatus time
Time Frame: one day
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one day
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xerostomia
Time Frame: one day
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one day
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Le-Qun Li, MD, Guangxi Medical University Cancer Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SD/GC-HCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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