Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2020-07-02

Brief Summary

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To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.

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Detailed Description

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Pelvic lymph node dissection is the most accurate staging tool to determine lymph node involvement in endometrial cancer. Lymphoceles developed after surgery can cause serious morbidity, additional costs and delays in chemotherapy or radiotherapy. In this study, conventional pelvic lymphadenectomy will be compared with thrombin gel matrix application after pelvic lymphadenectomy. Our goal is to prospectively assess the lymphostatic effect of thrombin gel matrix in endometrial cancer patients undergoing pelvic lymph node dissection.

Conditions

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Lymphocele Lymphocele After Surgical Procedure Endometrium Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional pelvic lymphadenectomy

Group Type ACTIVE_COMPARATOR

Conventional Pelvic lymphadenectomy

Intervention Type PROCEDURE

Conventional Pelvic lymphadenectomy

Thrombin gel matrix pelvic lymphadenectomy

Thrombin gel matrix applicated after conventional pelvic lymphadenectomy

Group Type EXPERIMENTAL

Thrombi-Gel

Intervention Type DRUG

Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy

Interventions

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Thrombi-Gel

Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy

Intervention Type DRUG

Conventional Pelvic lymphadenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Endometrial cancer patients who need laparotomic bilateral PLND
* Patients suitable for surgery

Exclusion Criteria

* Previous pelvic surgery
* Previous Chemotherapy or Radiotherapy
* Patients who undergo only lymph node sampling
* Patients who have not signed Informed Consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No