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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
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Paweł Miotła, Medical University of Lublin

Brief Summary:

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).

Methods:

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

Detailed Description:
The study was approved by the Bioethics Committee of the Medical University of Lublin, Lublin, Poland (KE-0254/276/2013). The study population consisted of 50 women undergoing pelvic lymphadenectomy for cervical and endometrial cancer and meeting the inclusion/exclusion criteria requirements. Inclusion criteria for the study included women undergoing open hysterectomy and lymphadenectomy for cervical or endometrial cancer, age between 18 and 70 years, who signed a written informed consent. Exclusion criteria included women with previously diagnosed lymph edema or disease of the lymphatic system or a known disease of the immune system. Prospective randomized clinical intervention trial of 50 open surgery during 2013-2014 at 2nd Department of Gynecology in Lublin. Women were centrally randomized by the principal investigator (TR). Surgeons allocated Tachosil for one side (left or right) after lymphadenectomy, second side was as a control side without Tachosil. 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. The open surgery were performed as follows: in women who underwent routine pelvic lymphadenectomy, lymph node tissue was removed from the external iliac vessels, the obturator fossa, the interiliac region, and the common iliac region after identification and appropriate preparation of iliac vessels and obturator nerve. At the end of the procedure, hemostasis was checked. 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. The next step was a radical hysterectomy with adnexa. After completion of the procedure, the stump of the vagina stitching to the hollow was performed by passing the vaginal seam through the vaginal wall, the right-side sacro-uterus ligament, the right round ligament, the peritoneal uterine vesiculitis, the left round ligament, the left sacro-uterine ligament and finally the vaginal wall. This way of fixation allowed free lymphatic drainage of the retroperitoneal space. Two drains from the vicinity of the pits of the curtains were removed through the abdominal wall, which were left to the second day after surgery or longer if the volume of secretion in the drainage exceeded 40 ml per day. The urinary bladder catheter was removed on the third day after surgery and ultrasound after voiding (PVR) was evaluated. Surgical procedures were performed by four doctors with extensive experience in oncological gynecology. The surgical protocols were blinded to other researchers who controlled patients in the postoperative period. The data obtained by them were analyzed by an independent reviewer. The evaluation criteria of the study were the development of lymph cysts and their volume. Antibiotic prophylaxis was implemented according to local hospital recommendations. In addition, metronidazole was administered at a dose of 500 mg every 8 hours. i.v. for the first three days after the procedure. Patients also received small-molecule heparin at a dose of 4,000 IU from the day preceding the surgery up to 30 days after its completion. Due to the fact that lymphatic cysts usually appear 7 to 15 days after lymphadenectomy, the ultrasound examination of the presence and volume of lymphocele was performed on the 7th and 30th day after the surgery and after completing the oncological complementary treatmentThe criteria proposed by Tinelli et al. were used to define lymphocele.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: TachoSil

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with cervical or endometrial cancer age between 18 and 70 years signed a written informed consent
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cervical cancer (FIGO IA1, IA2, IB1, IB2)
  • endometrial cancer (FIGO IA, IB, II)
  • age between 18 and 70 years
  • signed a written informed consent

Exclusion Criteria:

  • lymph edema
  • disease of the lymphatic system
  • a known disease of the immune system

Information from the National Library of Medicine

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


Locations
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Poland
IInd Department of Gynecology
Lublin, Poland, 20-954
Sponsors and Collaborators
Medical University of Lublin
Takeda
Investigators
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Principal Investigator: Tomasz Rechberger, Prof IInd Department of Gynecology, Medical University of Lublin, Poland

Publications of Results:
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Responsible Party: Paweł Miotła, Clinical Proffesor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03752606     History of Changes
Other Study ID Numbers: 022018
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Supporting Materials: Study Protocol
Time Frame: from now to ongoing
Access Criteria: from the corresponding author on reasonable request.
Keywords provided by Paweł Miotła, Medical University of Lublin:
lymphadenectomy
lymphocele
endometrial cancer
cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Endometrial Neoplasms
Lymphocele
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cysts
Lymphatic Diseases