Breast-cancer
Conditions
Keywords
Mastectomy flap fixation
Brief summary
The goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. The main questions it aims to answer are: \- To compare seroma formation after mastectomy flap fixation with conventional surgery in breast cancer patients Participants will be randomly divided into 2 groups, 1. Mastectomy flap fixation 2. Conventional surgery with non flap fixation. Researchers will record the amount and color of drainage fluid, patient and tumor characteristics, and operative related factor after surgery. Researchers will compare with conventional surgery to see if seroma formation, and wound infection.
Detailed description
Seroma is collection of blood plasma or lymphatic fluid under skin flap or axillary dead space. It occurred after modified radical mastectomy. Patient will have subcutaneous swelling or edema which be confirmed by physical examination or bedside ultrasound. It categorized by common terminology criteria for adverse events version 5.0 for 3 grades. 1. asymptomatic 2. symptomatic with medical intervention or simple aspiration 3. symptomatic with required interventional radiology or operative intervention.
Interventions
PROCEDUREFlap fixation technique
After complete the modified radical mastectomy procedure, the researcher will use absorbable sutures (vicryl), multiple alternating stitched 2.5 cm apart between the subcutaneous of the flap and underlying muscle
Sponsors
Nakhon Phanom Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The statistician will generate randomization list from block randomization, then concealed envelope
Intervention model description
Single blinded randomized control trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Breast cancer (CA Breast) patients plan to modified radical mastectomy * Operable case, or Resectable case
Exclusion criteria
* Having medical bleeding tendency e.g., Idiopathic Thrombocytopenia (ITP), leukemia, other bleeding disorder * Immunocompromised e.g., HIV, Systemic Lupus Erythematosus (SLE), liver cirrhosis, immunosuppressive drug * Other modified radical mastectomy whom required reconstruction, flap coverage e.g., Transverse Rectus Abdominis Musculocutaneous (TRAM) flap, Latissimus Dorsi (LD) flap * Past history of mammoplasty, augmentation * Past history of axillary lymphatic system operation * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroma Formation | Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period. | Every day for 7 days post operative period, fluid from drains was recorded (ml) daily. After discharge during follow up period, seroma formation was observed if seroma was observed, aspiration was performed and recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date | Data were assessed 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days. Data from any time point were combined by counted and sum number of specific outcome of interest. | 1. wound infection; any clinical signs and symptoms of wound infection, redness , swelling, wound dehiscence, of Fever \> 38 C. 2. Joint stiffness; limitation of range of movement of Shoulder same side of mastectomy. 3. Visit before the appointment date; any visit relevant surgical conditions before appointment. |
Countries
Thailand
Participant flow
Recruitment details
A single-blinded randomized control trial was conducted between December 2023 to June 2024. All operable breast cancer patients who were 18 years old and over, early and locally advance breast cancer who underwent modified radical mastectomy by single surgeon in Nakhonphanom hospital were screened
Pre-assignment details
Excluded accidental finding liver cirrhosis before surgery (n=1), plan to move another province (n=1)
Participants by arm
| Arm | Count |
|---|---|
| Flap Fixation Average age was 53±14 years. 13 patients with class I obesity (BMI \> 25kg/m2) and above. 5 (14.7%)patients received neoadjuvant chemotherapy. Average operative time were 57±10 minutes. Average blood loss was 33.53±13.23 ml.
Most of breast cancer cell type in this group was invasive ductal carcinoma = 32. Average tumor size in group A was 3.5 cm. Most of patients in this group were diagnosed in stage 2A, 14(41.18%).1 patients had distance metastasis, (2.94%). | 34 |
| Non Flap Fixation Average 58±10 years. 13 patients with class I obesity (BMI \> 25kg/m2) and above. 9 (26.47%) patients received neoadjuvant chemotherapy. Average operative time was 58±10 minutes. Average blood loss was 35.88±17.60 ml.
Most of breast cancer cell type in this group was invasive ductal carcinoma = 31 Average tumor size 4.09 cm. Most of patients in this group were diagnosed in stage 2A, 12 (35.29%). 4 (11.76%) patients had distance metastasis. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | Non Flap Fixation | Total | Flap Fixation |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10 | 56 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 24 |
| Body mass index | 23.91 kg/m2 STANDARD_DEVIATION 4.49 | 24.23 kg/m2 STANDARD_DEVIATION 4.16 | 24.59 kg/m2 STANDARD_DEVIATION 3.84 |
| Co-morbidity | 22 Participants | 40 Participants | 18 Participants |
| Neo-adjuvant chemotherapy | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 34 Participants | 68 Participants | 34 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Thailand | 34 participants | 68 participants | 34 participants |
| Sex: Female, Male Female | 34 Participants | 68 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 3 / 34 | 10 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Seroma Formation
Every day for 7 days post operative period, fluid from drains was recorded (ml) daily. After discharge during follow up period, seroma formation was observed if seroma was observed, aspiration was performed and recorded.
Time frame: Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period.
Population: Analysis population is patients whom randomized were performed operation as randomized and have data during follow up period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flap Fixation | Seroma Formation | Follow up 42 days | 0.00 ml | Standard Deviation 0 |
| Flap Fixation | Seroma Formation | Follow up 63 days | 0.00 ml | Standard Deviation 0 |
| Flap Fixation | Seroma Formation | Follow up 84 days | 0.00 ml | Standard Deviation 0 |
| Flap Fixation | Seroma Formation | Follow up 21 days | 0.00 ml | Standard Deviation 0 |
| Flap Fixation | Seroma Formation | post operative day 0 | 54.27 ml | Standard Deviation 27.47 |
| Flap Fixation | Seroma Formation | post operative day 1 | 102.21 ml | Standard Deviation 40.02 |
| Flap Fixation | Seroma Formation | post operative day 2 | 85.00 ml | Standard Deviation 40.82 |
| Flap Fixation | Seroma Formation | post operative day 3 | 63.38 ml | Standard Deviation 26.9 |
| Flap Fixation | Seroma Formation | post operative day 4 | 53.68 ml | Standard Deviation 24.81 |
| Flap Fixation | Seroma Formation | post operative day 5 | 45.59 ml | Standard Deviation 23.05 |
| Flap Fixation | Seroma Formation | post operative day 6 | 30.59 ml | Standard Deviation 18.37 |
| Flap Fixation | Seroma Formation | post operative day 7 | 15.44 ml | Standard Deviation 14.27 |
| Flap Fixation | Seroma Formation | Follow up 7 days | 40.00 ml | Standard Deviation 18.26 |
| Flap Fixation | Seroma Formation | Follow up 15 days | 20.00 ml | Standard Deviation 0 |
| Non Flap Fixation | Seroma Formation | post operative day 2 | 94.24 ml | Standard Deviation 39.06 |
| Non Flap Fixation | Seroma Formation | Follow up 42 days | 86.25 ml | Standard Deviation 31.98 |
| Non Flap Fixation | Seroma Formation | post operative day 7 | 26.18 ml | Standard Deviation 21.61 |
| Non Flap Fixation | Seroma Formation | Follow up 63 days | 30.00 ml | Standard Deviation 0 |
| Non Flap Fixation | Seroma Formation | post operative day 3 | 82.50 ml | Standard Deviation 45.75 |
| Non Flap Fixation | Seroma Formation | Follow up 84 days | 0.00 ml | Standard Deviation 0 |
| Non Flap Fixation | Seroma Formation | Follow up 15 days | 72.50 ml | Standard Deviation 55 |
| Non Flap Fixation | Seroma Formation | post operative day 6 | 42.06 ml | Standard Deviation 23.36 |
| Non Flap Fixation | Seroma Formation | Follow up 21 days | 72.50 ml | Standard Deviation 55 |
| Non Flap Fixation | Seroma Formation | post operative day 4 | 60.29 ml | Standard Deviation 29.64 |
| Non Flap Fixation | Seroma Formation | post operative day 0 | 59.56 ml | Standard Deviation 49.78 |
| Non Flap Fixation | Seroma Formation | Follow up 7 days | 86.19 ml | Standard Deviation 56.88 |
| Non Flap Fixation | Seroma Formation | post operative day 1 | 117.94 ml | Standard Deviation 43.14 |
| Non Flap Fixation | Seroma Formation | post operative day 5 | 55.00 ml | Standard Deviation 28.37 |
p-value: <0.005t-test, 2 sided
Secondary
Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date
1. wound infection; any clinical signs and symptoms of wound infection, redness , swelling, wound dehiscence, of Fever \> 38 C. 2. Joint stiffness; limitation of range of movement of Shoulder same side of mastectomy. 3. Visit before the appointment date; any visit relevant surgical conditions before appointment.
Time frame: Data were assessed 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days. Data from any time point were combined by counted and sum number of specific outcome of interest.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flap Fixation | Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date | wound infection | 0 Participants |
| Flap Fixation | Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date | joint stiffness | 3 Participants |
| Flap Fixation | Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date | visit before follow up date | 0 Participants |
| Non Flap Fixation | Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date | wound infection | 2 Participants |
| Non Flap Fixation | Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date | joint stiffness | 2 Participants |
| Non Flap Fixation | Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date | visit before follow up date | 6 Participants |
p-value: <0.05Fisher Exact