Simo Decoction and Acupuncture on POI in Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): simo decoction; gum chewing
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention