LymphoceleNCT04205864
Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.
A study testing Thrombi-Gel and Conventional Pelvic lymphadenectomy in people with Lymphocele and Lymphocele After Surgical Procedure, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Lymphocele, Lymphocele After Surgical Procedure, Endometrium Cancer
- What is being tested?
- Thrombi-Gel and Conventional Pelvic lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2019to 2 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endometrial cancer patients who need laparotomic bilateral PLND
- Patients suitable for surgery
Who cannot join
- Previous pelvic surgery
- Previous Chemotherapy or Radiotherapy
- Patients who undergo only lymph node sampling
- Patients who have not signed Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.
Read the detailed description
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.
- Being tested
- Thrombi-Gel, Conventional Pelvic lymphadenectomy
- Medical subject headings
- Lymphocele, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombi-GelDrug
Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy
Conventional Pelvic lymphadenectomyProcedure or surgery
Conventional Pelvic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Conventional pelvic lymphadenectomy | Active comparator | Conventional pelvic lymphadenectomy Receives: Procedure: Conventional Pelvic lymphadenectomy |
| Thrombin gel matrix pelvic lymphadenectomy | Experimental | Thrombin gel matrix applicated after conventional pelvic lymphadenectomy Receives: Drug: Thrombi-Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pelvic lymphocele
Frequency pelvic lymphocele at post-operative 2th month
Measured: post-operative 2th month
Secondary outcomes (3)
Volume of radiographic lymphoceles
Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres)
Measured: post-operative 2th month
duration of postoperative drainage catheter
duration of postoperative drainage catheter
Measured: up to post-operative 1 week
Postoperative drain amount (ml: milliliters)
Postoperative drain amount (ml: milliliters)
Measured: with 1 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start20 Dec 2019
- Primary completion1 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şener Gezer, Kocaeli University
- Investigators
- Şener Gezer, M.D, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205864
- Sponsor's protocol ID
- KIA 2019/93
- Status last verified
- Jul 2020
- First submitted
- 13 Dec 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim YH, Shin HJ, Ju W, Kim SC. Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study. J Gynecol Oncol. 2017 May;28(3):e37. doi: 10.3802/jgo.2017.28.e37. Epub 2017 Feb 28.
PubMed 28382800
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.
- ClinicalTrials.gov ID
- NCT04205864
- Acronym / sponsor ID
- KIA 2019/93
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.
| Arm | Type | Receives |
|---|---|---|
| Conventional pelvic lymphadenectomy | Active comparator | Procedure: Conventional Pelvic lymphadenectomyConventional pelvic lymphadenectomy |
| Thrombin gel matrix pelvic lymphadenectomy | Experimental | Drug: Thrombi-GelThrombin gel matrix applicated after conventional pelvic lymphadenectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endometrial cancer patients who need laparotomic bilateral PLND
- Patients suitable for surgery
Key exclusion criteria (4 listed)
- Previous pelvic surgery
- Previous Chemotherapy or Radiotherapy
- Patients who undergo only lymph node sampling
- Patients who have not signed Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombi-GelThrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy | Drug | Thrombin gel matrix pelvic lymphadenectomy |
| Conventional Pelvic lymphadenectomyConventional Pelvic lymphadenectomy | Procedure or surgery | Conventional pelvic lymphadenectomy |
Primary outcome
Frequency of pelvic lymphocele
Time frame: post-operative 2th month
Frequency pelvic lymphocele at post-operative 2th month
3 secondary outcomes
Volume of radiographic lymphoceles
Time frame: post-operative 2th month
duration of postoperative drainage catheter
Time frame: up to post-operative 1 week
Postoperative drain amount (ml: milliliters)
Time frame: with 1 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 28382800Kim YH, Shin HJ, Ju W, Kim SC. Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study. J Gynecol Oncol. 2017 May;28(3):e37. doi: 10.3802/jgo.2017.28.e37. Epub 2017 Feb 28.
- Individual participant dataSharing planned: No
Related trials for Lymphocele
Recruiting
Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
Lymphocele
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şener Gezer, M.D principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombi-Gel and Conventional Pelvic lymphadenectomy in people with Lymphocele and Lymphocele After Surgical Procedure, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of pelvic lymphocele (time frame: post-operative 2th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.