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Seroma is one of the most common encountered morbidities after inguinal lymph node dissection (ILND). It can cause not only much nuisance to both patients and doctors but also its presence can lead to many complications. This study aimed at evaluation of the role and effect of using fibrin glue on seroma reduction in patients undergoing ILND. Thirty-two patient have undergone ILND for various causes. The patients were randomized into two groups; 16 ILND in each. In one group, fibrin glue sealant was applied with a dose of 2ml per 100 cm2 surface area then drain placement was performed. Whereas, in the control group, only drain placement was used. Preoperative, operative and postoperative data were recorded and analyzed.
Seroma is one of the most frequent complications occurring after ILND as it affects nearly one third of these cases. During the past decades, many actions have been tried in the perioperative care to decrease the incidence of these complications, as employing well vascularized bulky flaps to obliterate the dead space and to protect vessels, great saphenous vein sparing, strict bed rest and fibrin sealant application. Realizing the underlying pathology for seroma formation is the key point in its prevention. Thirty-nine patients scheduled to perform Inguinal lymphadenectomy for various causes have been checked for eligibility to be enrolled in this prospective, randomized study. Thirty-two patients have met the inclusion criteria. Inguinal lymphadenectomy has been performed including scarifying saphenous vein. Sartorius muscle transposition flap was routinely performed for protection of femoral vessels, then an 18 French conventional non-suction tube drain was inserted in all patients. All the previous steps were similar in both groups. At this stage, the wound was closed for the control group, while fibrin glue was prepared to be applied to the fibrin glue group in a dose of 2mL for 100 cm2 surface area. Postoperatively, the daily collected drain fluid was measured till the drain was removed when the daily drainage was less than 30 ml. Then the patients were planned to be followed up postoperatively for at least 4 weeks, to detect the possible clinically encountered complications as seroma, wound infection, or skin flap necrosis.
Patients' demographic data and preexisting co-morbidities were recorded. Operative and pathological data regarding defect size, blood transfusion, primary tumor pathology, and number and status of retrieved lymph nodes were collected. The occurrence of post-operative seroma was the primary outcome. Other non serious adverse effect as hematoma, infection, or skin flap necrosis were recorded and compared between the two groups.
The normality of distribution of variables was verified by Kolmogorov- Smirnov test. Chi-square test (Fisher or Monte Carlo) was used for comparisons between groups for categorical variables. Student t-test was used to compare two groups for normally distributed quantitative variables. For not normally distributed quantitative variables, Mann Whitney test was used to compare between two groups. P value was set to be significant if <0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin glue | Experimental | A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain. |
|
| Control | No Intervention | Lymphadenctomy wound was closed after insertion of a drain, |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of fibrin glue sealant | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Seroma Formation | Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered. Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated | 4 weeks postpertively |
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Inclusion Criteria:
• Patients scheduled to perform ILND for various causes
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Ashraf Balbaa, M.D. | Menoufia University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22424660 | Background | Buda A, Fruscio R, Pirovano C, Signorelli M, Betti M, Milani R. The use of TachoSil for the prevention of postoperative complications after groin dissection in cases of gynecologic malignancy. Int J Gynaecol Obstet. 2012 Jun;117(3):217-9. doi: 10.1016/j.ijgo.2011.12.021. Epub 2012 Mar 15. |
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Study protocol will be available to be shared on request after study publication for 6 months.
Six months from the time of study publication
Contacting the corresponding author
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibrin Glue | A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain. Application of fibrin glue sealant |
| FG001 | Control | Lymphadenctomy wound was closed after insertion of a drain, |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibrin Glue | A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain. Application of fibrin glue sealant |
| BG001 | Control | Lymphadenctomy wound was closed after insertion of a drain, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Seroma Formation | Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered. Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated | Serum formation has been looked for | Posted | Number | participants | 4 weeks postpertively |
|
The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.
Hematoma, infection and partial superficial skin edge necrosis have been recorded as adverse effects that are categorized as "Other" adverse effects as per clinical trails.gov definitions,
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibrin Glue | A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain. Application of fibrin glue sealant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Ashraf BAlbaa | Menoufia Univeristy | +20482224216 | mohamed.balbaa@med.menofia.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2020 | Aug 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D049291 | Seroma |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Inguinal lymphadenectomy | Number | participants |
|
Lymphadenctomy wound was closed after insertion of a drain,
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Control | Lymphadenctomy wound was closed after insertion of a drain, | 0 | 16 | 0 | 16 | 9 | 16 |
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Partial superficial skin edge necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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