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Lymphocele clinical trials

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NCT ID: NCT06284135 Completed - Clinical trials for Lymphocele After Surgical Procedure

MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles

Start date: June 19, 2017
Phase: N/A
Study type: Interventional

A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention.

NCT ID: NCT05398458 Completed - Varicose Veins Clinical Trials

Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report

Start date: January 1, 2019
Phase:
Study type: Observational

A 48-year-old female presented to the plastic surgery outpatient department (OPD) with a history of painful, progressive swelling of the right groin and medial aspect of the right thigh for 4 months. After investigation, it was diagnosed as a giant lymphocele. A pedicled gracilis muscle flap was used to reconstruct and obliterate the cavity. There was no recurrence of the swelling. : Lymphocele is a common complication after extensive vascular surgeries. In the unfortunately case of its development, prompt intervention must be done to prevent its growth and ensuing complications.

NCT ID: NCT04853095 Completed - Prostate Cancer Clinical Trials

Effect of Peritoneal Fixation on Lymphocele Formation

PerFix
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The PerFix Trial aims to compare the use of peritoneal fixation technique to standard of care (no fixation) during robot-assisted radical prostatectomy with extended pelvic lymph node dissection (RARP + eLND) for the prevention of symptomatic and radiologic lymphocele formation.

NCT ID: NCT04205864 Completed - Endometrium Cancer Clinical Trials

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

Start date: December 20, 2019
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03914963 Completed - Lymphocele Clinical Trials

Efficacy of a Fibrin Sealant for the Prevention of Lymphocele After Lymphadenectomy

Start date: February 1, 2012
Phase: Phase 3
Study type: Interventional

Objective: Lymphocele (LC) is a potential complication of lymph node removal. The objective of this study was to assess the efficacy of the Tissucol Duo® (Baxter AG Industriestrasse 67 A-1221 Vienna, Austria) fibrin sealant in decreasing the incidence of LC after pelvic laparoscopic lymph node dissection using harmonic shears. Material and Methods: This prospective double blind randomised study was conducted between February 2012 and June 2016 in Donostia University Hospital (Spain). Overall, 74 patients diagnosed with gynaecological cancer gave written informed consent and were included in the study. After bilateral pelvic lymphadenectomy, the fibrin sealant was used following manufacturer's instructions in one hemipelvis but not the other. Overall, the product was applied in 41 (55.4%) left and 33 (44.6%) right hemipelvises. The primary objective of the study was to determine the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography and magnetic resonance) was performed to detect LC at 3, 6 and 12 months after surgery.

NCT ID: NCT03765320 Completed - Gynecologic Cancer Clinical Trials

Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection

Start date: November 6, 2018
Phase:
Study type: Observational

To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection.

NCT ID: NCT03752606 Completed - Cervical Cancer Clinical Trials

Application of Tachosil During Lymphadenectomy

Start date: November 29, 2013
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03567525 Completed - Clinical trials for Lymphocele After Surgical Procedure

Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

Start date: September 14, 2018
Phase: N/A
Study type: Interventional

Lymphoceles are a potentially serious complication of radical prostatectomy (RP) with pelvic lymph node dissection. They are associated with abdominal pain, urinary tract symptoms, fever, lower extremity swelling and deep vein thrombosis. They can be severe enough to necessitate intervention in 5% of patients after RRP with PLND, with sequela that could include infection and nerve damage. Studies evaluating strategies to preclude lymphocele formation after RP have included comparisons of the use of titanium clips vs bipolar coagulation to seal lymphatic vessels during pelvic lymph node dissection. In a recent prospective randomized trial comparing these approaches, no differences were observed in the rates of lymphocele formation as detected by ultrasound. There is a need to continue to test potential strategies to minimize the formation of lymphoceles after RRP. Creation of a peritoneal iliac flap is one approach has potential towards this end. At the Lahey Hospital and Medical Center in Burlington, MA surgeons routinely fold the bladder into a peritoneal flap to overlay the area of extended lymphadenectomy. It is thought that this method prevents the formation of lymphoceles because the flap creates a window, which allows drainage of the lymph fluid into the peritoneal cavity to be reabsorbed. While the Lahey study supports the safety and effectiveness of the peritoneal flap approach, the procedure has never been evaluated through a randomized prospective trial and the practice is certainly not standard of care. We therefore propose a randomized, prospective clinical trial to be conducted in the Hartford Hospital Urology Department to examine the effectiveness of a peritoneal iliac flap on the formation of lymphoceles after RRP with pelvic lymph node dissection. Hypotheses: 1. We hypothesize that, at 3 months after RP, rates of lymphocele formation (symptomatic and asymptomatic lymphoceles) will be significantly lower in patients who have pelvic lymph node dissection using the peritoneal iliac flap approach than in patients who have pelvic lymph node dissection using the standard approach. 2. Lymphoceles are often associated with lower urinary tract symptoms. We hypothesize that, after RP, severity of urinary bother symptoms and urinary incontinence will be significantly lower at each measurement period for patients who had pelvic lymph node dissection using the peritoneal iliac flap approach relative to patients who had pelvic lymph node dissection using the standard approach.

NCT ID: NCT02658851 Completed - Clinical trials for Lymphoceles Following Pelvic Lymph Node Dissection

Cold Plasma for the Reduction of Lymphoceles Following PLND

Start date: June 2016
Phase: N/A
Study type: Interventional

This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.

NCT ID: NCT02476357 Completed - Lymphoedema Clinical Trials

A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

Start date: January 2009
Phase: N/A
Study type: Interventional

Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.