Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-02-23 @ 1:10 AM
Study NCT ID:
NCT02480361
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2015-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045823', 'term': 'Ileus'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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'}], 'primaryOutcomes': [{'measure': 'Remnant sitz markers in small intestine at postoperative day 1', 'timeFrame': 'measured in postoperative day 1', 'description': 'Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 1.'}, {'measure': 'Remnant sitz markers in small intestine at postoperative day 3', 'timeFrame': 'measured in postoperative day 3', 'description': 'Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 3.'}, {'measure': 'Remnant sitz markers in small intestine at postoperative day 5', 'timeFrame': 'measured in postoperative day 5', 'description': 'Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 5.'}, {'measure': 'Remnant sitz markers in small intestine at postoperative day 7', 'timeFrame': 'measured in postoperative day 7', 'description': 'Numbers of of remnant sitz markers in the small intestine that did not pass through ileo-cecal valve, measured by X-ray on postoperative day 7.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'Gastric cancer'], 'conditions': ['Ileus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective surgery for gastric cancers\n* Patients with American Society of Anesthesiologists grades I-III\n* Patients who provided written informed consent\n\nExclusion Criteria:\n\n* Patients who developed intraoperative problems or complications\n* Patients with contraindications to had electrical stimulation devices (pacemaker or implantable defibrillator)\n* Patients who were allergic to acupuncture needle'}, 'identificationModule': {'nctId': 'NCT02480361', 'acronym': 'EAPIG', 'briefTitle': 'Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)', 'organization': {'class': 'OTHER', 'fullName': 'Daegu Catholic University Medical Center'}, 'officialTitle': 'Effect of Acupuncture on Postoperative Ileus After Gastrectomy in Patients With Gastric Cancer: A Pilot Study', 'orgStudyIdInfo': {'id': 'APOIGC-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'The patients who were received acupuncture after gastric cancer surgery', 'interventionNames': ['Device: acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'Non-acupuncture', 'description': 'The patients who were not received acupuncture after gastric cancer surgery'}], 'interventions': [{'name': 'acupuncture', 'type': 'DEVICE', 'description': 'Acupuncture treatment after gastric cancer surgery during 5 postoperative days', 'armGroupLabels': ['Acupuncture']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hyun-dong Chae, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Surgery, School of Medicine, Catholic University of Daegu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daegu Catholic University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'In-Hwan Kim', 'investigatorAffiliation': 'Daegu Catholic University Medical Center'}}}}