Clinical trial NCT03724656: Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery
Official title: Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery in Patients Undergoing Non-gastrointestinal Abdominal Surgery: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Dysfunction
Keywords: Transcutaneous Acupoint Electrical Stimulation
non-gastrointestinal abdominal surgery
gastrointestinal motility
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. Research name: Effects of intraoperative stimulation of acupoints on postoperative gastrointestinal motility recovery in patients undergoing non-gastrointestinal abdominal surgery.
2. Research center: Multicenter research
3. Research design: A randomized controlled study method would be used in this study, in which the investigators would provide electroacupuncture on the basis of general anesthesia for non-gastrointestinal abdominal surgery. The effects of electroacupuncture on postoperative gastrointestinal motility recovery in patients undergoing non-gastrointestinal abdominal surgery will be observed and compared with the control group.
4. Research population: Patients who are greater or equal to 18 years old and less than 64 years old , meanwhile intend to receive selective/limited non-gastrointestinal surgery under general anesthesia.
5. Number of participants: 600
6. Interventions: The treatment group received electroacupuncture intervention 30 minutes before induction of anesthesia. In the treatment group, bilateral Neiguan point, bilateral Zusanli point and bilateral Hegu point were selected, then electroacupuncture was applied and the needle was retained until the end of operation. The control group was treated with non-acupoint shallow acupuncture method. The needle was inserted 5 cm beside the acupoint and the needling depth was less than 2 mm. At the same time, the manual stimulation was avoided, "Deqi" was not obtained, electroacupuncture was applied, electric current was regulated, and the needle was retained until the end of the operation.

Detailed description: This study is a large sample, randomized, double-blinded, placebo-controlled and long-term follow-up design. In this study, bilateral Neiguan(PC6), bilateral Zusanli(ST36)and bilateral Hegu (LI4)points were selected for perioperative TAES treatment. accompanied with evaluating the postoperative gastrointestinal motility, the incidence of postoperative nausea and vomiting , as well as the effects on postoperative NRS pain and sleep quality scores . To clarify the effect of TAES on the postoperative spontaneous voiding in patients for laparoscopic surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world.

Eligibility criteria: Inclusion Criteria:

1. Inclusion Criteria

Subjects enrolled in this study must accord with all of the following criteria:

1. Age ≥ 18 years old and \<64 years old, gender, ethnicity is not limited;
2. It is intended to selective/limited non-gastrointestinal surgery under general anesthesia;
3. Agree to participate in the study and sign an informed consent form;

Exclusion Criteria:

1. Refusing to participate in this study;
2. Patients with cardiac pacemakers and some special groups, such as pregnant women and those who have had many long-term acupuncture treatment experience;
3. Patients with peptic ulcer, perforation or obstruction;
4. Patients with chronic liver and renal dysfunction, and those who use β-blockers or antihypertensive drugs;
5. The attending doctors or researchers believe that there are other unsuitable situations for the study.

Primary outcomes:
measure: postoperative venting
timeFrame: an average of 1 year
Secondary outcomes:
measure: Biochemical tests
timeFrame: 12 months
measure: bowel sounds and defecation
timeFrame: an average of 1 year
measure: Postoperative nausea and vomiting
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Nankai Hospital of Tianjin
name: Yu Jianbo, Professor
role: STUDY_CHAIR
References:
citation: Lee CH, Kim DK, Yook TH, Sasaki M, Kitamura N. Effectiveness of electroacupuncture at Zusanli (ST36) on the immunohistochemical density of enteroendocrine cells related to gastrointestinal function. J Acupunct Meridian Stud. 2012 Apr;5(2):63-71. doi: 10.1016/j.jams.2012.01.002. Epub 2012 Feb 4.
citation: Wang CP, Kao CH, Chen WK, Lo WY, Hsieh CL. A single-blinded, randomized pilot study evaluating effects of electroacupuncture in diabetic patients with symptoms suggestive of gastroparesis. J Altern Complement Med. 2008 Sep;14(7):833-9. doi: 10.1089/acm.2008.0107.
citation: Gungorduk K, Ozdemir IA, Gungorduk O, Gulseren V, Gokcu M, Sanci M. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial. Am J Obstet Gynecol. 2017 Feb;216(2):145.e1-145.e7. doi: 10.1016/j.ajog.2016.10.019. Epub 2016 Oct 22.