Simo Decoction and Acupuncture on POI in Colorectal Cancer

NCT02813278 | Completed Phase 3 DMC

• 1 other identifier: SMD/POI
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• First flatus time

  one day

• Length of hospital stay

  one day

Study Arms (3)

simo decoction and acupuncture with vitamin B1

EXPERIMENTAL

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.

Dietary Supplement: simo decoction

gum chewing

ACTIVE COMPARATOR

Patients will receive gum chewing (three times per day) in the first day after resection for 5 days or until flatus.

Other: gum chewing

empty control

NO INTERVENTION

Patients only receive best support care.

Interventions

simo decoction DIETARY_SUPPLEMENT

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.

simo decoction and acupuncture with vitamin B1

gum chewing OTHER

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.

gum chewing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent open or laparoscopic colorectal cancer resection
• Diagnosis of colorectal cancer was confirmed by histopathological examination of surgical samples in all patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Yang Yang

Nanning, Guangxi, 530021, China

Location

Related Publications (4)

• 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.

  PMID: 25524125 BACKGROUND

• 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.

  PMID: 26445178 BACKGROUND

• 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.

  PMID: 27146793 BACKGROUND

• 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.

  PMID: 28102199 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Le-Qun Li

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 24, 2016
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 27, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)