Simo Decoction and Gum Chewing for Bowel Activity

Study Overview
=================
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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Dietary Supplement: simo decoction
* Other: gum chewing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simo decoction<br>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. | Dietary Supplement: simo decoction<br> <br> |
| Active Comparator: gum chewing<br>Patients will receive gum chewing (three times per day) in the first day after resection until flatus. | Other: gum chewing<br> <br> |
| No Intervention: empty control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First flatus time |  | one day | 
| xerostomia |  | one day |