Fibrin Glue in Inguinal Lymphadenectomy

NCT ID: NCT04666051

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Seroma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fibrin glue

A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.

Group Type: EXPERIMENTAL

Application of fibrin glue sealant

Intervention Type: BIOLOGICAL

Control

Lymphadenctomy wound was closed after insertion of a drain,

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Application of fibrin glue sealant

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients scheduled to perform ILND for various causes

Exclusion Criteria

• BMI more than 35,
• Uncompensated diabetes
• Advanced liver disease
• Previous history of surgery and/or irradiation to the inguinal region
• Preoperative chemotherapy
• Significant coagulation disorders
• Platelet counts <100,000/mL.
• Use of systemic steroids or anticoagulants.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

M. Ashraf Balbaa

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M. Ashraf Balbaa, M.D.

Role: STUDY_DIRECTOR

Menoufia University

References

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.

Reference Type: BACKGROUND

PMID: 22424660 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

4/2015/SURG

Identifier Type: -

Identifier Source: org_study_id