ID

31745

Description

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT01473784

Link

https://clinicaltrials.gov/show/NCT01473784

Keywords

Versions (1)
  1. 9/24/18 9/24/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 24, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Recurrent Adenoid Cystic Carcinoma of the Oral Cavity NCT01473784

English

Eligibility Recurrent Adenoid Cystic Carcinoma of the Oral Cavity NCT01473784

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
Description

Indication Diagnostic procedure Oral cavity diseases | Indication Therapeutic procedure Oral cavity diseases | Indication Diagnostic procedure Disorder of laryngopharynx | Indication Therapeutic procedure Disorder of laryngopharynx | Lesion Neoplastic Tongue | Lesion Neoplastic Tongue base | Lesion Neoplastic Retromolar trigone | Lesion Neoplastic Tonsils | Lesion Neoplastic Palate | Lesion Neoplastic Posterior pharynx | Neoplasm of lateral wall of pharynx | Lesion Neoplastic Glottic larynx | Lesion Neoplastic Supraglottic larynx | Lesion Neoplastic Subglottic larynx

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0026636
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0026636
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0430022
UMLS CUI [3,3]
C0544058
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0544058
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C1709160
UMLS CUI [5,3]
C0040408
UMLS CUI [6,1]
C0221198
UMLS CUI [6,2]
C1709160
UMLS CUI [6,3]
C0226958
UMLS CUI [7,1]
C0221198
UMLS CUI [7,2]
C1709160
UMLS CUI [7,3]
C0226920
UMLS CUI [8,1]
C0221198
UMLS CUI [8,2]
C1709160
UMLS CUI [8,3]
C0836921
UMLS CUI [9,1]
C0221198
UMLS CUI [9,2]
C1709160
UMLS CUI [9,3]
C0700374
UMLS CUI [10,1]
C0221198
UMLS CUI [10,2]
C1709160
UMLS CUI [10,3]
C2367481
UMLS CUI [11]
C2103120
UMLS CUI [12,1]
C0221198
UMLS CUI [12,2]
C1709160
UMLS CUI [12,3]
C0017681
UMLS CUI [13,1]
C0221198
UMLS CUI [13,2]
C1709160
UMLS CUI [13,3]
C2239273
UMLS CUI [14,1]
C0221198
UMLS CUI [14,2]
C1709160
UMLS CUI [14,3]
C0934489
patients must have adequate transoral exposure of the oral cavity and laryngopharynx for tors instrumentation
Description

Oral cavity Appropriate Transoral Robotic Surgery Instrumentation | Laryngopharynx Appropriate Transoral Robotic Surgery Instrumentation

Data type

boolean

Alias
UMLS CUI [1,1]
C0226896
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2986516
UMLS CUI [1,4]
C1704339
UMLS CUI [2,1]
C0020629
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C2986516
UMLS CUI [2,4]
C1704339
written informed consent and/or consent waiver by institutional review board (irb)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unexplained fever and/or untreated, active infection
Description

Unexplained fever | Communicable Disease untreated

Data type

boolean

Alias
UMLS CUI [1]
C1844662
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332155
patient pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
previous head and neck surgery precluding transoral/robotic procedures
Description

Head and neck surgery Previous Excludes Procedure by transoral approach | Head and neck surgery Previous Excludes Robotic Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1512343
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C1298719
UMLS CUI [2,1]
C1512343
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C3850136
the presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Description

Medical contraindication General Anesthesia | Medical contraindication Procedure by transoral approach

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002915
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1298719
inability to grant informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
intraoperative exclusion criteria:
Description

Exclusion Criteria Intraoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0456904
inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Description

Visualization Anatomy Unable | Procedure by transoral approach Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0178707
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1298719
UMLS CUI [2,2]
C1272705
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Similar models

Eligibility Recurrent Adenoid Cystic Carcinoma of the Oral Cavity NCT01473784

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Diagnostic procedure Oral cavity diseases | Indication Therapeutic procedure Oral cavity diseases | Indication Diagnostic procedure Disorder of laryngopharynx | Indication Therapeutic procedure Disorder of laryngopharynx | Lesion Neoplastic Tongue | Lesion Neoplastic Tongue base | Lesion Neoplastic Retromolar trigone | Lesion Neoplastic Tonsils | Lesion Neoplastic Palate | Lesion Neoplastic Posterior pharynx | Neoplasm of lateral wall of pharynx | Lesion Neoplastic Glottic larynx | Lesion Neoplastic Supraglottic larynx | Lesion Neoplastic Subglottic larynx
Item
patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
boolean
C3146298 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0026636 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0026636 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0430022 (UMLS CUI [3,2])
C0544058 (UMLS CUI [3,3])
C3146298 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0544058 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C1709160 (UMLS CUI [5,2])
C0040408 (UMLS CUI [5,3])
C0221198 (UMLS CUI [6,1])
C1709160 (UMLS CUI [6,2])
C0226958 (UMLS CUI [6,3])
C0221198 (UMLS CUI [7,1])
C1709160 (UMLS CUI [7,2])
C0226920 (UMLS CUI [7,3])
C0221198 (UMLS CUI [8,1])
C1709160 (UMLS CUI [8,2])
C0836921 (UMLS CUI [8,3])
C0221198 (UMLS CUI [9,1])
C1709160 (UMLS CUI [9,2])
C0700374 (UMLS CUI [9,3])
C0221198 (UMLS CUI [10,1])
C1709160 (UMLS CUI [10,2])
C2367481 (UMLS CUI [10,3])
C2103120 (UMLS CUI [11])
C0221198 (UMLS CUI [12,1])
C1709160 (UMLS CUI [12,2])
C0017681 (UMLS CUI [12,3])
C0221198 (UMLS CUI [13,1])
C1709160 (UMLS CUI [13,2])
C2239273 (UMLS CUI [13,3])
C0221198 (UMLS CUI [14,1])
C1709160 (UMLS CUI [14,2])
C0934489 (UMLS CUI [14,3])
Oral cavity Appropriate Transoral Robotic Surgery Instrumentation | Laryngopharynx Appropriate Transoral Robotic Surgery Instrumentation
Item
patients must have adequate transoral exposure of the oral cavity and laryngopharynx for tors instrumentation
boolean
C0226896 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2986516 (UMLS CUI [1,3])
C1704339 (UMLS CUI [1,4])
C0020629 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C2986516 (UMLS CUI [2,3])
C1704339 (UMLS CUI [2,4])
Informed Consent
Item
written informed consent and/or consent waiver by institutional review board (irb)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Unexplained fever | Communicable Disease untreated
Item
unexplained fever and/or untreated, active infection
boolean
C1844662 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Pregnancy
Item
patient pregnancy
boolean
C0032961 (UMLS CUI [1])
Head and neck surgery Previous Excludes Procedure by transoral approach | Head and neck surgery Previous Excludes Robotic Surgical Procedures
Item
previous head and neck surgery precluding transoral/robotic procedures
boolean
C1512343 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1298719 (UMLS CUI [1,4])
C1512343 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C3850136 (UMLS CUI [2,4])
Medical contraindication General Anesthesia | Medical contraindication Procedure by transoral approach
Item
the presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
boolean
C1301624 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1298719 (UMLS CUI [2,2])
Informed Consent Unable
Item
inability to grant informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Exclusion Criteria Intraoperative
Item
intraoperative exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0456904 (UMLS CUI [1,2])
Visualization Anatomy Unable | Procedure by transoral approach Unsuccessful
Item
inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
boolean
C0178707 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1298719 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
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