Clinical trial NCT02480361: Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)
Official title: Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileus
Keywords: Acupuncture
Gastric cancer
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is being accepted in the West as a treatment option for managing POI and various functional gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who underwent gastric surgery for a later large-scale study.

Detailed description: Before surgery, patients were randomized (using simple randomization) to either acupuncture (A) group or non-acupuncture (NA) group. In both groups, sitz markers were inserted in duodenum or jejunum during surgery for detection of postoperative remnant sitz markers by Xray. In the A group, acupuncture treatment was given once daily for up to 5 consecutive days starting on postoperative day 1. The acupuncture points which were used were based on traditional Korean medicine. No acupuncture treatment was performed in the NA group.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective surgery for gastric cancers
* Patients with American Society of Anesthesiologists grades I-III
* Patients who provided written informed consent

Exclusion Criteria:

* Patients who developed intraoperative problems or complications
* Patients with contraindications to had electrical stimulation devices (pacemaker or implantable defibrillator)
* Patients who were allergic to acupuncture needle

Primary outcomes:
measure: Remnant sitz markers in small intestine at postoperative day 1
timeFrame: measured in postoperative day 1
measure: Remnant sitz markers in small intestine at postoperative day 3
timeFrame: measured in postoperative day 3
measure: Remnant sitz markers in small intestine at postoperative day 5
timeFrame: measured in postoperative day 5
measure: Remnant sitz markers in small intestine at postoperative day 7
timeFrame: measured in postoperative day 7
Secondary outcomes:
measure: Time to first flatus
timeFrame: up to 5 dyas
measure: start of water intake
timeFrame: up to 7days
measure: start of soft diet
timeFrame: up to 7days
measure: hospital stay
timeFrame: up to 2 weeks
Other outcomes:
measure: white blood cell count in preoperative period
timeFrame: measured in day before operation
measure: white blood cell count in postoperative day 1
timeFrame: measured in postoperative day 1
measure: white blood cell count in postoperative day 3
timeFrame: measured in postoperative day 3
measure: white blood cell count in postoperative day 5
timeFrame: measured in postoperative day 5
measure: white blood cell count in postoperative day 7
timeFrame: measured in postoperative day 7
measure: serum C reactive protein level in preoperative period
timeFrame: measured in day before operation
measure: serum C reactive protein level in postoperative day 1
timeFrame: measured in postoperative day 1
measure: serum C reactive protein level in postoperative day 3
timeFrame: measured in postoperative day 3
measure: serum C reactive protein level in postoperative day 5
timeFrame: measured in postoperative day 5
measure: serum C reactive protein level in postoperative day 7
timeFrame: measured in postoperative day 7
measure: serum albumin level in preoperative period
timeFrame: measured in day before operation
measure: serum albumin level in postoperative day 1
timeFrame: measured in postoperative day 1
measure: serum albumin level in postoperative day 3
timeFrame: measured in postoperative day 3
measure: serum albumin level in postoperative day 5
timeFrame: measured in postoperative day 5
measure: serum albumin level in postoperative day 7
timeFrame: measured in postoperative day 7
Locations:
Study officials:
affiliation: Department of Surgery, School of Medicine, Catholic University of Daegu
name: Hyun-dong Chae, Professor
role: STUDY_DIRECTOR
References: