Application of Tachosil During Lymphadenectomy

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 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

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