Application of Tachosil During Lymphadenectomy
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|ClinicalTrials.gov Identifier: NCT03752606|
Recruitment Status : Completed
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
The prevention of lymphoceles was assessed using collagen patch coated with the human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland; NCT Number ICMJE NCT01192022; Other Study ID Numbers ICMJE TC-2402-040-SP; U1111-1130-9121 Registry Identifier: WHO) on 50 consecutive patients with endometrial and cervical cancer stages IB to II who had undergone open hysterectomy and pelvic lymphadenectomy (PL).
Each patient was simultaneously randomized in two groups: as a control (side without Tachosil applied) and study group (side with Tachosil applied). All surgical parameters were collected and patients underwent ultrasound examination on postoperative days 1, 6, and 30, and at the end of treatment.
|Condition or disease||Intervention/treatment||Phase|
|Lymphocele Endometrial Cancer Cervical Cancer||Biological: TACHOSIL GROUP||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||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.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Does Intraoperative Application of TachoSil Reduce the Number of Lymphocele After Pelvic Lymphadenectomy?|
|Actual Study Start Date :||November 29, 2013|
|Actual Primary Completion Date :||December 31, 2014|
|Actual Study Completion Date :||December 31, 2017|
Active Comparator: TACHOSIL GROUP
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.
Biological: TACHOSIL GROUP
Other Name: NCT01192022
No Intervention: GROUP WITHOUT TACHOSIL
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.
- The incidence and volume of lymphocele. [ Time Frame: 1 year ]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
- The incidence of lymphocele after adjuvant treatment [ Time Frame: 1 year ]Number of participants with lymphocele as assessed by USG scan after complement adjuvant treatament
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752606
|IInd Department of Gynecology|
|Lublin, Poland, 20-954|
|Principal Investigator:||Tomasz Rechberger, Prof||IInd Department of Gynecology, Medical University of Lublin, Poland|