Brief Title
Application of Tachosil During Lymphadenectomy
Official Title
Does Intraoperative Application of TachoSil Reduce the Number of Lymphocele After Pelvic Lymphadenectomy?
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.
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
The incidence and volume of lymphocele.
Secondary Outcome
The incidence of lymphocele after adjuvant treatment
Condition
Lymphocele
Intervention
TACHOSIL GROUP
Study Arms / Comparison Groups
TACHOSIL GROUP
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
50
Start Date
November 29, 2013
Completion Date
December 31, 2017
Primary Completion Date
December 31, 2014
Eligibility 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
Gender
Female
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Tomasz Rechberger, Prof, ,
Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT03752606
Organization ID
022018
Responsible Party
Principal Investigator
Study Sponsor
Medical University of Lublin
Collaborators
Takeda
Study Sponsor
Tomasz Rechberger, Prof, Principal Investigator, IInd Department of Gynecology, Medical University of Lublin, Poland
Verification Date
November 2018