Salvage lymphnode dissection is performed on the PSMA PET positive side, according to template (obturator, iliac external, iliac internal, iliac commun) and possibly including other anatomical pelvic regions

In addition, a salvage lymphnode dissection is performed on the opposite side with resection of the corresponding fields, which were taken on the PSMA-PET positive side

Prostate Cancer

A salvage lymphnode dissection is performed in all study patients (both arms)using standard surgical techniques (openly or DaVinci).In patients who were randomized to the bilateral pelvic lymphnode dissection group, a salvage lymphadenectomy was also performed on the opposite side with resection of the corresponding fields that were removed on the PSMA-PET positive side (th "Blinding" must be guaranteed during pathological assessment)

Salvage Lymphnode dissection

Martini-Klinik am UKE GmbH

Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)

Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s): is One-sided Salvage Extended Lymph Node Dissection Enough

cBR: PSA <0.2ng / ml after salvage lymph node dissection without adjuvant prostate cancer specific therapy

University Hospital Hamburg, Institute of Tumor Biology

Surgical procedures were performed by four doctors with extensive experience in oncological gynecology. A TachoSil® absorbable patch of 4.8x4.8 cm was attached, once, intraoperatively to one side of the obturator fossa (study group). Specific drainage of the retroperitoneum was performed.

The same patient constituted also control group, because no TachoSil® absorbable patche was used on the second side of lymphadenectomy. Specific drainage of the retroperitoneum was performed.

Lymphocele

Endometrial Cancer

Cervical Cancer

Women with cervical or endometrial cancer age between 18 and 70 years signed a written informed consent

TACHOSIL GROUP

IInd Department of Gynecology

Application of Tachosil During Lymphadenectomy

Does Intraoperative Application of TachoSil Reduce the Number of Lymphocele After Pelvic Lymphadenectomy?

Number of participants with lymphocele as assessed by USG scan at 1,6,30 days and the drainage volume in ml with/without Tachosil assessed by USG scan at 1,2,6,30 days

Number of participants with lymphocele as assessed by USG scan after complement adjuvant treatament

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Paweł Miotła

Clinical Proffesor

Medical University of Lublin

Takeda

A Tachosil® patch of 4.8x4.8 cm was attached to one side of the obturator fossa (study group) and the same patient constituted also control group, because no Tachosil® patch was used on the second side of lymphadenectomy. Specific drainage of the retroperitoneum was performed. Patients had to agree to participate in the study and signed informed consent at least one day before surgery. Taking into consideration the examined group the patient was allocated to, the surgeon applied either one Tachosil® patches in the study group or no Tachosil® in the control group. After placing for 4 minutes, a uniform pressure was applied to it to provide rapid haemostasis by forming a strong, fibrin clot adjacent to the tissue surface. Tachosil was placed alternately once in the left, once in the right obturator fossa, so that each of the patients participating in the study could be their own control.

Allocation was communicated by telephone after informed consent had been obtained and after lymphadenectomy had been completed. Outcome assessment was performed by the independent reviewers. Outcome assessors were blinded to the treatment allocation.

Prostate or Bladder Cancer

1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.

Ghent University Hospital

Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.

Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.

University Hospital, Ghent

A Tachosil® patch of 4.8x4.8cm will be attached to the obturator fossa and a Tachosil® patch of 4.8x4.8cm will be attached to the femoral canal of each side of surgery in the intervention group.

In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.

A Tachosil® patch of 4.8x4.8cm will be attached to the obturator fossa and a Tachosil® patch of 4.8x4.8cm will be attached to the femoral canal of each side of surgery in the intervention group. In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.

Tachosil fibrin patch

Medical University of Vienna

Ruhr University Bochum

Tachosil for the Prevention of Symptomatic Lymph Cysts

A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphoceles After Pelvic Lymphadenectomy in Women With Gynecologic Malignancies: a Randomized Clinical Trial

Primary outcome variable:
2.1. To evaluate the incidence of symptomatic pelvic lymphoceles defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery.

Secondary outcome variables:
2.2. To evaluate the incidence of sonographically detected pelvic lymphoceles of at least 2cm in the largest diameter 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery.
2.3. To evaluate the rate and type of medical interventions for clinically symptomatic pelvic lymphoceles such as analgesics and/or lymphocele puncture and drainage.

lymphocele/edema

Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)

Application of Tachosil During Lymphadenectomy

Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.

Tachosil for the Prevention of Symptomatic Lymph Cysts

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