Application of Tachosil During Lymphadenectomy

NCT03752606 | Completed Phase 4 DMC

• 1 other identifier: 022018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphocele; Endometrial Cancer; Cervical Cancer

Keywords

lymphadenectomy; lymphocele; endometrial cancer; cervical cancer

Outcome Measures

Primary Outcomes (1)

• The incidence and volume of lymphocele.

  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

  1 year

Secondary Outcomes (1)

• The incidence of lymphocele after adjuvant treatment

  1 year

Study Arms (2)

TACHOSIL GROUP

ACTIVE COMPARATOR

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

GROUP WITHOUT TACHOSIL

NO INTERVENTION

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.

Interventions

TACHOSIL GROUP BIOLOGICAL

Also known as: NCT01192022

TACHOSIL GROUP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Women with cervical or endometrial cancer age between 18 and 70 years signed a written informed consent
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Lublin: lead
• Takeda: collaborator

Study Sites (1)

IInd Department of Gynecology

Lublin, 20-954, Poland

Location

Related Publications (2)

• Tinelli A, Giorda G, Manca C, Pellegrino M, Prudenzano R, Guido M, Dell'Edera D, Malvasi A. Prevention of lymphocele in female pelvic lymphadenectomy by a collagen patch coated with the human coagulation factors: a pilot study. J Surg Oncol. 2012 Jun 15;105(8):835-40. doi: 10.1002/jso.22110. Epub 2011 Oct 10.

  PMID: 21987409 RESULT

• Tinelli A, Mynbaev OA, Tsin DA, Giorda G, Malvasi A, Guido M, Nezhat FR. Lymphocele prevention after pelvic laparoscopic lymphadenectomy by a collagen patch coated with human coagulation factors: a matched case-control study. Int J Gynecol Cancer. 2013 Jun;23(5):956-63. doi: 10.1097/IGC.0b013e31828eeea4.

  PMID: 23574881 RESULT

MeSH Terms

Conditions

Lymphocele; Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Study Officials

• Tomasz Rechberger, Prof

  IInd Department of Gynecology, Medical University of Lublin, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Proffesor

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 26, 2018
• Study Start: November 29, 2013
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2017
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from now to ongoing
• Access Criteria: from the corresponding author on reasonable request.

Locations

PL (1)