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Trial · NCT04758728

Registered outcomes34

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySubcutaneous ecchymoses number 1d-postop24 hours post-operativelyThe absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day
PrimarySubcutaneous ecchymoses number 8d-post-op192 hours post-operativelyThe absolute number of subcutaneous ecchymoses on the operated limb on 8th post-operative day
PrimarySubcutaneous ecchymoses number 14d-post-op336 hours post-operativelyThe absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day
PrimarySubcutaneous hematomas number 1d-postop24 hours post-operativelyThe absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day
PrimarySubcutaneous hematomas number 8d-postop192 hours post-operativelyThe absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day
PrimarySubcutaneous hematomas number 14d-postop336 hours post-operativelyThe absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day
PrimarySubcutaneous ecchymoses total area 1d-postop24 hours post-operativelyThe total area in mm2 of subcutaneous ecchymoses in the operated limb on 1st post-operative day
PrimarySubcutaneous ecchymoses total area 8d-postop192 hours post-operativelyThe total area in mm2 of subcutaneous ecchymoses in the operated limb on 8th post-operative day
PrimarySubcutaneous ecchymoses total area 14d-postop336 hours post-operativelyThe total area in mm2 of subcutaneous ecchymoses in the operated limb on 14th post-operative day
PrimarySubcutaneous hematomas total area 1d-postop24 hours post-operativelyThe total area in mm2 of subcutaneous hematomas in the operated limb on 1st post-operative day
PrimarySubcutaneous hematomas total area 8d-postop192 hours post-operativelyThe total area in mm2 of subcutaneous hematomas in the operated limb on 8th post-operative day
PrimarySubcutaneous hematomas total area 14d-postop336 hours post-operativelyThe total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day
PrimaryQoL-SF36 preop24 hours pre-operatively
Quality of life assessment based on the 36-Item Short Form Survey (SF-36) questionnaire preoperatively. It is an often-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The eight scaled scores, which are the weighted sums of the questions in their section are directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
PrimaryQoL-SF36 1month-postop30 days post-operatively
Quality of life assessment based on the 36-Item Short Form Survey (SF-36) questionnaire 30 days post-operatively. It is an often-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The eight scaled scores, which are the weighted sums of the questions in their section are directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
PrimaryQoL-CIVIQ2 preop24 hours pre-operatively
Quality of life assessment based on the ChronIc Venous Insufficiency quality of life Questionnaire version 2 (CIVIQ-2) questionnaire preoperatively. The CIVIQ was developed and validated (relevance, acceptability, reliability, construct validity, and sensitivity) by French researchers in 1996. The CIVIQ is a 20-item self-reported instrument that includes four categories of questions: physical (4 items), psychological (9 items), social (4 items), and pain (3 items). Its score ranges from 0, the worst score, to 100, the best. There are five possible answers (from 1 to 5) to describe each symptom and the sensation of discomfort. The second version, the CIVIQ-2 (where 2 denotes the second draft of the same questionnaire), provides a global score covering all aspects of the questionnaire and weighs the categories equally.
PrimaryQoL-CIVIQ2 1month post-op30 days post-operatively
Quality of life assessment based on the CIVIQ-2 questionnaire 1 month post-operatively. Quality of life assessment based on the ChronIc Venous Insufficiency quality of life Questionnaire version 2 (CIVIQ-2) questionnaire preoperatively. The CIVIQ was developed and validated (relevance, acceptability, reliability, construct validity, and sensitivity) by French researchers in 1996. The CIVIQ is a 20-item self-reported instrument that includes four categories of questions: physical (4 items), psychological (9 items), social (4 items), and pain (3 items). Its score ranges from 0, the worst score, to 100, the best. There are five possible answers (from 1 to 5) to describe each symptom and the sensation of discomfort. The second version, the CIVIQ-2 (where 2 denotes the second draft of the same questionnaire), provides a global score covering all aspects of the questionnaire and weighs the categories equally.
SecondaryHCT preop24 hours pre-operativelyHematocrit (HCT) measured pre-operatively, in percentage (%).
SecondaryHCT postop24 hours post-operativelyHematocrit (HCT) measured post-operatively, in percentage (%).
SecondaryHgb preop24 hours pre-operativelyHemoglobin (Hgb) measured pre-operatively, in mg/dL.
SecondaryHgb postop24 hours post-operativelyHemoglobin (Hgb) measured post-operatively, in mg/dL.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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