Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection (SP/GC-HCC)

Guangxi Medical University

Status and phase: Completed; Phase 3

Conditions: Liver Cancer

Treatments: Drug: smoked plum; Drug: gum chewing

Study type: Interventional

Funder types: Other

Identifiers

NCT02649153

SP/GC-HCC

Details and patient eligibility

About

Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. One third of the study population will receive smoked plum, one third with chewing gum, and the last will act as empty control.

Full description

Hepatectomy is widely used to treat patients with hepatocellular carcinoma (HCC), even those with intermediate and advanced disease. Despite its well-demonstrated clinical safety and efficacy in many patients, it is associated with postoperative morbidity and mortality. One complication after hepatectomy is delayed resumption of gastrointestinal function, known as postoperative ileus. This can decrease patient comfort and increase morbidity and mortality, prolonging hospital stay and raising healthcare costs. While postoperative ileus usually resolves within approximately 3 days, it can last longer in some cases as a condition termed postoperative paralytic ileus. Postoperative use of opioid-based analgesics can increase incidence of postoperative ileus.

No drugs or interventions to prevent or treat postoperative ileus have been approved by the China Drug Administration or the US Food and Drug Administration. Several studies show that chewing gum, a new and simple modality, can accelerate complication-free recovery of gastrointestinal function following gastrointestinal surgery and obstetrical-gynecological surgery. This raises the question whether postoperative smoked plum, or chewing gum can reduce risk of postoperative ileus following hepatectomy. To examine this question, we conducted a randomized controlled trial to compare incidence of postoperative ileus and length of hospital stay in HCC patients who received smoked plum, chewing gum or no intervention following hepatectomy.

Enrollment: 240 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

smoked plum

Experimental group

Description:

Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus.

Treatment:

Drug: smoked plum

gum chewing

Active Comparator group

Description:

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

Treatment:

Drug: gum chewing

empty control

No Intervention group

Description:

This group patients will not receive gum chewing or smoked plum.