Trial Outcomes & Findings for A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer (NCT NCT01321697)
NCT ID: NCT01321697
Last Updated: 2013-08-27
Results Overview
Recruitment status
TERMINATED
Target enrollment
7 participants
Primary outcome timeframe
at time of surgery
Results posted on
2013-08-27
Participant Flow
Participant milestones
| Measure |
Vulvar Cancer
Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Vulvar Cancer
Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
|
|---|---|
|
Overall Study
Study Terminated
|
7
|
Baseline Characteristics
A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer
Baseline characteristics by cohort
| Measure |
Vulvar Cancer
n=7 Participants
Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of surgeryPopulation: Data were not collected/analyzed due to study termination.
Outcome measures
Outcome data not reported
Adverse Events
Vulvar Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place