NCT02649153

Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Liver Cancer

Interventions

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

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2016-01-07
• Last updated: 2024-01-23

Locations

1 site across 1 country: China