Simo Decoction and Acupuncture on POI in Colorectal Cancer (SMD/POI)
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|ClinicalTrials.gov Identifier: NCT02813278|
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: simo decoction Other: gum chewing||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Colorectal Cancer Resection: a Randomized Clinical Trial|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: simo decoction and acupuncture with vitamin B1
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
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.
Active Comparator: gum chewing
Patients will receive gum chewing (three times per day) in the first day after resection for 5 days or until flatus.
Other: gum chewing
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.
No Intervention: empty control
Patients only receive best support care.
- First flatus time [ Time Frame: one day ]
- Length of hospital stay [ Time Frame: one day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813278
|Nanning, Guangxi, China, 530021|