Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection (SP/GC-HCC)
Primary Purpose
Liver Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
smoked plum
gum chewing
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer
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
Sites / Locations
- Affiliated Tumor of Guangxi UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
smoked plum
gum chewing
empty control
Arm Description
Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus.
Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
This group patients will not receive gum chewing or smoked plum.
Outcomes
Primary Outcome Measures
Time to first peristalsis
Secondary Outcome Measures
Full Information
NCT ID
NCT02649153
First Posted
January 5, 2016
Last Updated
February 26, 2022
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02649153
Brief Title
Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection
Acronym
SP/GC-HCC
Official Title
Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
smoked plum
Arm Type
Experimental
Arm Description
Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus.
Arm Title
gum chewing
Arm Type
Active Comparator
Arm Description
Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
Arm Title
empty control
Arm Type
No Intervention
Arm Description
This group patients will not receive gum chewing or smoked plum.
Intervention Type
Drug
Intervention Name(s)
smoked plum
Intervention Description
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
Intervention Name(s)
gum chewing
Intervention Description
Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
Primary Outcome Measure Information:
Title
Time to first peristalsis
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-Hong Zhong, MD
Phone
86-0771-5350036
Email
zhongjianhong66@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Le-Qun Li, MD
Organizational Affiliation
Affiliated Tumor of Guangxi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Tumor of Guangxi University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
5350021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Hong Zhong, MD
Phone
86-0771-5350036
Email
zhongjianhong66@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
26559269
Citation
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.
Results Reference
result
PubMed Identifier
22672009
Citation
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.
Results Reference
result
Learn more about this trial
Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection
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