Lymphedema, Post Mastectomy
Conditions
Brief summary
This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema
Interventions
PROCEDURELymphaticovenous Micro-Anastomosis
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A lymphatic diversion with lymphaticovenous microanastomosis will be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject is 18-70 years of age * Subject is Stage II-IV unilateral lymphedema
Exclusion criteria
* Subject is less than 6 months from completion of cancer treatment * Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue) * Subject is medically unfit for the procedure * Subject is unable to complete the follow-up visits * Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence. * Subject has bilateral lymphedema
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery | 3 and 6 months from surgery | Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lymphaticovenous Micro-Anastomosis Lymphaticovenous Micro-Anastomosis | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Lymphaticovenous Micro-Anastomosis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Count of Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.
Time frame: 3 and 6 months from surgery
Population: Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.