Simo Decoction and Gum Chewing for Bowel Activity (SD/GC-HCC)

Guangxi Medical University

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Dietary Supplement: simo decoction; Other: gum chewing

Study type: Interventional

Funder types: Other

Identifiers

NCT02438436

SD/GC-HCC

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

simo decoction

Experimental group

Description:

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.

Treatment:

Dietary Supplement: simo decoction

gum chewing

Active Comparator group

Description:

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

Treatment:

Other: gum chewing

empty control

No Intervention group