Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-04-13 @ 1:34 AM
Study NCT ID:
NCT01679418
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2012-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-09-05', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of post-operative nausea using visual analogue scale (VAS)', 'timeFrame': '24 hours post surgery', 'description': 'The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.'}, {'measure': 'Assessment of postoperative vomiting using visual analogue scale (VAS)', 'timeFrame': '24 hours post surgery', 'description': 'The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery'}, {'measure': 'Assessment of post-operative nausea using visual analogue scale (VAS)', 'timeFrame': '48 hours post surgery', 'description': 'The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.'}, {'measure': 'Assessment of postoperative vomiting using visual analogue scale (VAS)', 'timeFrame': '48 hours post surgery', 'description': 'The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery'}], 'secondaryOutcomes': [{'measure': 'Antiemetic therapy post surgery in patients with and without postoperative drainage', 'timeFrame': 'after 48 hours', 'description': 'In the postoperative course, we counted the amount of anti-emetic interventions for patients post surgery over the first 48 hours. The givage of anti-emetic drugs was based on a prior determined protocol, that was strictly followed.\n\nThe protocol was as follows for antiemetic drugs:\n\nFirst line Drug: Tropisetron 2 mg i.v. when patient is vomiting, max. twice a day. Second line therapy: Haloperidol 0.5 mg i.v. with a maximum of 3 mg every 24 hours, when first line therapy is not sufficient. The change to second line therapy is controlled by the study physician.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PONV', 'thyroid', 'surgery', 'nausea and vomiting', 'postoperative'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '9082107', 'type': 'BACKGROUND', 'citation': 'Schwarz W, Willy C, Ndjee C. [Gravity or suction drainage in thyroid surgery? Control of efficacy with ultrasound determination of residual hematoma]. Langenbecks Arch Chir. 1996;381(6):337-42. doi: 10.1007/BF00191314. German.'}, {'pmid': '31243574', 'type': 'DERIVED', 'citation': 'Kunzli BM, Walensi M, Wilimsky J, Bucher C, Buhrer T, Kull C, Zuse A, Maurer CA. Impact of drains on nausea and vomiting after thyroid and parathyroid surgery: a randomized controlled trial. Langenbecks Arch Surg. 2019 Sep;404(6):693-701. doi: 10.1007/s00423-019-01799-6. Epub 2019 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and Vomiting (PONV)', 'detailedDescription': 'Postoperative nausea and vomiting (PONV) is common after thyroid surgery. Many patients describe PONV as more irritant in the postoperative course than the endured pain. Postoperative drains are put after thyroid surgery to early recognize bleeding and to collect wound secretion to avoid pressure on the trachea. Whether wound drains do impact on PONV is not known. Therefore, we tested the impact of wound drains on PONV after thyroid- and parathyroid surgery in a randomized controlled clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years of age\n* informed consent\n* planed thyroid- or parathyroid resection\n* euthyreostatic preoperative condition\n\nExclusion Criteria:\n\n* younger than 18 years of age\n* pregnancy\n* no informed consent\n* retrosternal struma\n* known postoperative nausea and vomiting prior to surgery\n* severe and life threatening systemic health issues'}, 'identificationModule': {'nctId': 'NCT01679418', 'acronym': 'PONTS', 'briefTitle': 'Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Liestal'}, 'officialTitle': 'Randomized Controlled Trial on the Impact of Postoperative Drainage on Nausea and Vomiting After Thyroid- and Parathyroid Surgery', 'orgStudyIdInfo': {'id': 'PONV_thyroidsurgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drain placement (Group A)', 'description': 'Patients in group A received a wound drain after surgery.', 'interventionNames': ['Device: Placement of a wound drain post surgery (Redon; Medicoplast)']}, {'type': 'SHAM_COMPARATOR', 'label': 'No-drain placement (group B)', 'description': 'Patients assigned to group B, did not receive a wound drain after surgery.', 'interventionNames': ['Other: No-drain after surgery']}], 'interventions': [{'name': 'Placement of a wound drain post surgery (Redon; Medicoplast)', 'type': 'DEVICE', 'otherNames': ['Redon Drainage (Ref. 750), 3.0 mm in diameter', 'Medicoplast, 66557 Illingen, Germany'], 'description': 'The wound drain, type Redon Drainage 3.0 mm in diameter', 'armGroupLabels': ['Drain placement (Group A)']}, {'name': 'No-drain after surgery', 'type': 'OTHER', 'description': 'After surgery, no drain was put', 'armGroupLabels': ['No-drain placement (group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonsspital Liestal', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'overallOfficials': [{'name': 'Christoph A Maurer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Surgery, Head of the Department, Kantonsspital Liestal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Liestal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Christoph A. Maurer, MD', 'investigatorAffiliation': 'Kantonsspital Liestal'}}}}