Simo Decoction and Gum Chewing for Bowel Activity

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Dietary Supplement: simo decoction; Other: gum chewing

• Registration Number: NCT02438436
• Lead Sponsor: Guangxi Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
simo decoction	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.
gum chewing	gum chewing	Patients will receive gum chewing (three times per day) in the first day after resection until flatus.

Primary Outcome Measures

Name	Time	Method
First flatus time	one day
xerostomia	one day

Trial Locations

Locations (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University; 🇨🇳 Nanning, Guangxi, China