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

NCT ID: NCT02649153

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

smoked plum

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

Group Type: EXPERIMENTAL

smoked plum

Intervention Type: DRUG

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

gum chewing

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

Group Type: ACTIVE_COMPARATOR

gum chewing

Intervention Type: DRUG

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

empty control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

smoked plum

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

Intervention Type: DRUG

gum chewing

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Hong Zhong

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Le-Qun Li, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Tumor of Guangxi University

Locations

Affiliated Tumor of Guangxi University

Nanning, Guangxi, China

Countries

China

References

You XM, Mo XS, Ma L, Zhong JH, Qin HG, Lu Z, Xiang BD, Wu FX, Zhao XH, Tang J, Pang YH, Chen J, Li LQ. Randomized Clinical Trial Comparing Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Patients With Hepatocellular Carcinoma After Hepatectomy. Medicine (Baltimore). 2015 Nov;94(45):e1968. doi: 10.1097/MD.0000000000001968.

Reference Type: RESULT

PMID: 26559269 (View on PubMed)

Jang SY, Ju EY, Kim DE, Kim JH, Kim YH, Son M, Jang M, Jeong JH, Kim KS. First flatus time and xerostomia associated with gum-chewing after liver resection. J Clin Nurs. 2012 Aug;21(15-16):2188-92. doi: 10.1111/j.1365-2702.2012.04132.x. Epub 2012 Jun 2.

Reference Type: RESULT

PMID: 22672009 (View on PubMed)

Other Identifiers

SP/GC-HCC

Identifier Type: -

Identifier Source: org_study_id