Simo Decoction and Acupuncture on POI in Colorectal Cancer (SMD/POI)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
simo decoction
gum chewing
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Underwent open or laparoscopic colorectal cancer resection
- Diagnosis of colorectal cancer was confirmed by histopathological examination of surgical samples in all patients
Exclusion Criteria:
- Previously underwent exploratory laparotomy
- 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
- Yang Yang
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
simo decoction and acupuncture with vitamin B1
gum chewing
empty control
Arm 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 for 5 days or until flatus.
Patients will receive gum chewing (three times per day) in the first day after resection for 5 days or until flatus.
Patients only receive best support care.
Outcomes
Primary Outcome Measures
First flatus time
Length of hospital stay
Secondary Outcome Measures
Full Information
NCT ID
NCT02813278
First Posted
June 22, 2016
Last Updated
June 23, 2016
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02813278
Brief Title
Simo Decoction and Acupuncture on POI in Colorectal Cancer
Acronym
SMD/POI
Official Title
Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Colorectal Cancer Resection: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Colorectal cancer resection is one of the most common types of abdominal surgery. Though most patients undergoing colorectal resection show recovery of bowel movements within a week, some have prolonged intestinal paralysis or postoperative ileus, resulting in decreasing patient comfort, increasing morbidity and mortality, a longer hospital stay and subsequent increased healthcare costs.
Detailed Description
Prevention the incidence of postoperative ileus (POI) is quite important because of the negative clinical outcomes it causes. In the past two decades, many treatments and care approaches, such as fluid restriction, early enteral nutrition, and nonsteroidal anti-inflammatory drug are used for the management of POI. In theory of traditional Chinese medicine, oral simo decoction (SMD) or acupuncture at the tsusanli acupoint can boost gastrointestinal hypomotility. The efficacy of accelerating the return of gastrointestinal function by such single method or combination of them has been validated in randomized controlled trials and systematic review following several types of surgery. In recent years, chewing gum, a new and simple modality, has become a commonly applied method in order to prevent and reduce the POI. Systematic reviews and meta-analyses revealed that chewing gum provided significant benefits for the improvement of postoperative bowel function. More importantly, many official guidelines recommend chewing gum for an evidence-based approach in the prevention of POI. Despite these positive evidence, three newest randomized controlled trials are unable to demonstrate an effect of chewing gum on the recovery of bowel function after colorectal resection.
It is important to note that almost all previous randomized controlled trials are based on small sample size. This raises the question whether postoperative SMD, acupuncture at the tsusanli acupoint, or chewing gum can reduce risk of POI following colorectal resection among patients with large sample size. To examine this question, we conducted this randomized controlled trial to compare incidence of POI and length of hospital stay in colorectal cancer patients who received SMD and acupuncture, chewing gum or no intervention following resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
simo decoction and acupuncture with vitamin B1
Arm Type
Experimental
Arm 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 for 5 days or 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 for 5 days or until flatus.
Arm Title
empty control
Arm Type
No Intervention
Arm Description
Patients only receive best support care.
Intervention Type
Dietary Supplement
Intervention Name(s)
simo decoction
Intervention Description
Participants allocated to SMD and acupuncture were asked to take oral SMD decoction (Hansen Co., Ltd., Yiyang, Hunan province, China, 10 mL/dose) three times per day beginning on the first day after colorectal resection. They also received bilateral injections of vitamin B1 (50 mg x 2) at the tsusanli acupoint one time per day. This intervention was performed for a total of 5 consecutive days or until flatus.
Intervention Type
Other
Intervention Name(s)
gum chewing
Intervention Description
Participants allocated to chewing gum were instructed to chew commercially available sugar-free gum (Extra & Reg, Wm. Wrigley Jr. Co., Ltd., Shanghai, China) three times daily starting on the first postoperative morning. They were instructed to chew the piece of gum for at least 10 min. This intervention was performed for 5 consecutive days or until flatus.
Primary Outcome Measure Information:
Title
First flatus time
Time Frame
one day
Title
Length of hospital stay
Time Frame
one day
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 or laparoscopic colorectal cancer resection
Diagnosis of colorectal cancer was confirmed by histopathological examination of surgical samples in all patients
Exclusion Criteria:
Previously underwent exploratory laparotomy
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
Facility Information:
Facility Name
Yang Yang
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25524125
Citation
van den Heijkant TC, Costes LM, van der Lee DG, Aerts B, Osinga-de Jong M, Rutten HR, Hulsewe KW, de Jonge WJ, Buurman WA, Luyer MD. Randomized clinical trial of the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery. Br J Surg. 2015 Feb;102(3):202-11. doi: 10.1002/bjs.9691. Epub 2014 Dec 18.
Results Reference
background
PubMed Identifier
26445178
Citation
Kobayashi T, Masaki T, Kogawa K, Matsuoka H, Sugiyama M. Efficacy of Gum Chewing on Bowel Movement After Open Colectomy for Left-Sided Colorectal Cancer: A Randomized Clinical Trial. Dis Colon Rectum. 2015 Nov;58(11):1058-63. doi: 10.1097/DCR.0000000000000452.
Results Reference
background
PubMed Identifier
27146793
Citation
Atkinson C, Penfold CM, Ness AR, Longman RJ, Thomas SJ, Hollingworth W, Kandiyali R, Leary SD, Lewis SJ. Randomized clinical trial of postoperative chewing gum versus standard care after colorectal resection. Br J Surg. 2016 Jul;103(8):962-70. doi: 10.1002/bjs.10194. Epub 2016 May 5.
Results Reference
background
PubMed Identifier
28102199
Citation
Yang Y, Zuo HQ, Li Z, Qin YZ, Mo XW, Huang MW, Lai H, Wu LC, Chen JS. Comparison of efficacy of simo decoction and acupuncture or chewing gum alone on postoperative ileus in colorectal cancer resection: a randomized trial. Sci Rep. 2017 Jan 19;7:37826. doi: 10.1038/srep37826.
Results Reference
derived
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Simo Decoction and Acupuncture on POI in Colorectal Cancer
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