Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01620151
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2012-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain score', 'timeFrame': 'First postoperative week', 'description': "Post-operative pain ranges from 0 to 10 according to the Visual Analogue pain scale (VAS), and which 0 is 'No pain' and 10 is 'Worst possible pain'"}], 'secondaryOutcomes': [{'measure': 'Surgically related complications', 'timeFrame': 'Immediate and after 6 months', 'description': 'Neck exposure, duration of operation, skin incision length, intra-operative blood loss, RLN injury, post-operative hypocalcaemia'}, {'measure': 'Postoperative pain scores', 'timeFrame': 'Day 0, day 1 and after two weeks', 'description': "Post-operative pain ranges from 0 to 10 according to the Visual Analogue pain scale (VAS), and which 0 is 'No pain' and 10 is 'Worst possible pain'"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-operative pain', 'Wound bleeding requiring exploration', 'PTH', 'RLN complication', 'Hypocalcaemia complication'], 'conditions': ['Post-operative Pain']}, 'referencesModule': {'references': [{'pmid': '19199002', 'type': 'BACKGROUND', 'citation': 'Bae JS, Park WC, Song BJ, Jung SS, Kim JS. Endoscopic thyroidectomy and sentinel lymph node biopsy via an anterior chest approach for papillary thyroid cancer. Surg Today. 2009;39(2):178-81. doi: 10.1007/s00595-008-3840-5. Epub 2009 Feb 7.'}, {'pmid': '15933531', 'type': 'BACKGROUND', 'citation': 'Terris DJ, Bonnett A, Gourin CG, Chin E. Minimally invasive thyroidectomy using the Sofferman technique. Laryngoscope. 2005 Jun;115(6):1104-8. doi: 10.1097/01.MLG.0000163761.03764.44.'}, {'pmid': '11510599', 'type': 'BACKGROUND', 'citation': 'Park CS, Chung WY, Chang HS. Minimally invasive open thyroidectomy. Surg Today. 2001;31(8):665-9. doi: 10.1007/s005950170066.'}, {'pmid': '14616561', 'type': 'BACKGROUND', 'citation': "Serpell JW, Grodski SF, O'Donell C. Does neck extension elevate the thyroid gland cephalad to potentially improve access during thyroidectomy? ANZ J Surg. 2003 Nov;73(11):887-9. doi: 10.1046/j.1445-2197.2003.02845.x."}, {'pmid': '9707207', 'type': 'BACKGROUND', 'citation': 'Weintraub MI, Khoury A. Cerebral hemodynamic changes induced by simulated tracheal intubation: a possible role in perioperative stroke? Magnetic resonance angiography and flow analysis in 160 cases. Stroke. 1998 Aug;29(8):1644-9. doi: 10.1161/01.str.29.8.1644.'}, {'pmid': '16105529', 'type': 'BACKGROUND', 'citation': 'Lang BH, Lo CY. Total thyroidectomy for multinodular goiter in the elderly. Am J Surg. 2005 Sep;190(3):418-23. doi: 10.1016/j.amjsurg.2005.03.029.'}, {'pmid': '17479325', 'type': 'BACKGROUND', 'citation': 'Clements RH, Palepu R. In vivo comparison of the coagulation capability of SonoSurg and Harmonic Ace on 4 mm and 5 mm arteries. Surg Endosc. 2007 Dec;21(12):2203-6. doi: 10.1007/s00464-007-9345-2. Epub 2007 May 4.'}, {'pmid': '12807591', 'type': 'BACKGROUND', 'citation': 'Warden V, Hurley AC, Volicer L. Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. J Am Med Dir Assoc. 2003 Jan-Feb;4(1):9-15. doi: 10.1097/01.JAM.0000043422.31640.F7.'}, {'pmid': '7431615', 'type': 'BACKGROUND', 'citation': 'Beaver WT. Management of cancer pain with parenteral medication. JAMA. 1980 Dec 12;244(23):2653-7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Primary: To compare the post-operative pain in patients with neck extension and without neck extension.\n\nSecondary: To determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups.\n\nHypothesis: Patients who undergoing thyroidectomy without neck extension will have less post-operative pain and there are no significant difference of post-operation complications between both groups.', 'detailedDescription': 'Conventional open thyroid surgery is still one of the most common operations performed globally. Traditionally, patients who undergoing thyroid surgeries are usually positioned with extended neck by using pillow under shoulder in order to facilitate neck exposure and make the surgery easier. However, the degree of benefit from the extended neck is doubtful and there is little objective evidence that suggest extended neck thyroid surgery offers better outcomes. On the the hand, over-extension of the neck should be avoided because of it is associated with post-operative pain, vomiting, spinal damage and stroke. The objective of the present study is to compare the post-operative pain in patients with neck extension and without neck extension. In addition to that, we also like to determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups. This is a prospective randomized controlled trial, which will be conducted from 1st of March 2012 till 30th September 2012. Given that approximately 300 to 400 patients would undergo thyroid surgery in each year, we estimated 180 patients will be recruited and randomly divided into 2 groups (neck extension and no neck extension) before undergoing open thyroid surgery for this trial. Visual analogue scale (VAS) is used to determine the post-operative pain. Primary end point and other peri-operative variables are then analyzed with SPSS software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who will be undergoing thyroid surgery in Queen Mary Hospital and Tung Wah Hospital.\n* Age from 18 till 80 years old.\n\nExclusion Criteria:\n\n* Patients with history of bleeding disorder and tendency.\n* Patients with history of cervical spine surgery and disease.\n* Patients with history of RLN injury and underlying cause of hypocalcemia.\n* Patient with mental disorder and subnormal intelligence.\n* Pregnant and lactating women.\n* Patients who is having other surgical problem that needed other surgical procedure performed at the same setting.'}, 'identificationModule': {'nctId': 'NCT01620151', 'briefTitle': 'Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Post-operative Pain & Outcomes of Open Thyroidectomy; Extended Neck vs No Extended Neck', 'orgStudyIdInfo': {'id': 'RCTECS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No extended neck', 'description': 'Patient will not undergo thyroid surgery with extended neck'}, {'type': 'EXPERIMENTAL', 'label': 'Extended neck', 'description': 'Patients who undergoing thyroid surgeries are positioned with extended neck by using pillow under shoulder in order to facilitate neck exposure and make the surgery easier.', 'interventionNames': ['Procedure: Extended neck with standard support or pillow']}], 'interventions': [{'name': 'Extended neck with standard support or pillow', 'type': 'PROCEDURE', 'otherNames': ['neck extension', 'neck hyper-extension'], 'description': 'Patient will undergo thyroid surgery with an extended neck', 'armGroupLabels': ['Extended neck']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Sheung Wan', 'country': 'Hong Kong', 'facility': 'Tung Wah Hospital', 'geoPoint': {'lat': 22.28383, 'lon': 114.1496}}], 'overallOfficials': [{'name': 'Hung Hin, Brian Lang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Clinical Associate Professor', 'investigatorFullName': 'Dr. Lang Hung Hin, Brian', 'investigatorAffiliation': 'The University of Hong Kong'}}}}