Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT03818633
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2019-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elastic Abdominal Binder Following Gynecologic Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily average postoperative pain scores', 'timeFrame': 'An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation', 'description': "The participants are asked to rate postoperative pain according to 10-cm visual analog scales from '0' (no pain) to '10' (worst possible pain)."}, {'measure': 'Six-minute walk test score change from baseline', 'timeFrame': 'One day before operation and postoperative day 3', 'description': 'Six-minute walk test (6MWT)'}], 'secondaryOutcomes': [{'measure': "Quality of life: EuroQol Group's ED-5D-5L questionnaire", 'timeFrame': 'In the morning of postoperative day 3', 'description': 'The EuroQol Group\'s ED-5D-5L questionnaire is employed. The health dimensions assessed include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the participants are asked to indicate their health state related to that dimension as no problems (score \'1\'), slight problems (score \'2\'), moderate problems (score \'3\'), severe problems (score \'4\'), and extreme problems (score \'5\'). For this study, a score of 1-2 is considered "normal" while a scores of 3-5 is regarded as "problem". In addition, the participants are asked to rate their overall health status according to a visual analog scale EQ VAS with \'0\' corresponding to "the worst health imaginable" and \'100\' indicating "the best health imaginable".'}, {'measure': 'Rate of postoperative complications', 'timeFrame': 'In the morning, up to 7 days postoperation', 'description': 'The complications of interest include febrile morbidity, wound complication, bowel ileus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': "Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides opportunities for removal of the affected organs and complete assessment of extent of cancer spread. However, the procedures are often associated with significant morbidity. This is especially true with open laparotomy, the most frequently employed approach in developing countries. Delayed functional recovery influenced by pain and immobilization are important contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient population have not been properly examined.\n\nThe aim of this study is to examine the effect of postoperative elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test \\[6MWT\\]) in postoperative gynecologic cancer patients who use versus do not use the elastic abdominal binder to support incisional site."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women, diagnosed with gynecologic malignancies (carcinoma of the cervix, endometrium, and ovary), undergoing open abdominal surgery\n\nExclusion Criteria:\n\n* Intraoperative accidental injury to urinary or gastrointestinal organs\n* Postoperative admission to intensive care unit (ICU)\n* Postoperative intraperitoneal drain placement\n* Unable to understand and follow oral/written instructions\n* Severe neuromuscular or circulatory disorders'}, 'identificationModule': {'nctId': 'NCT03818633', 'briefTitle': 'Elastic Abdominal Binder Following Gynecologic Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OBG-2560-05147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elastic abdominal binder', 'interventionNames': ['Device: Elastic abdominal binder']}, {'type': 'NO_INTERVENTION', 'label': 'No binder'}], 'interventions': [{'name': 'Elastic abdominal binder', 'type': 'DEVICE', 'description': "Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.", 'armGroupLabels': ['Elastic abdominal binder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Kittipat Charoenkwan', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Kittipat Charoenkwan, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kittipat Charoenkwan, MD', 'investigatorAffiliation': 'Chiang Mai University'}}}}