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Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)

This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS),…

Spinal Bupivacaine/Morphine in laparoscopic gastro-intestinal surgery

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with retroperitoneal sarcoma (RPS)

To assess whether preoperative radiotherapy, as an adjunct to curative-intent surgery, improves the abdominal local recurrence-free survival.

REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus* Valve System - Randomized Clinical Evaluation

The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus* Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered…

A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys from donors older than 50 years of age and donated after circulatory death.

To compare the effect of oxygenated versus non-oxygenated hypothermic machine perfusion of grafts of DCD category III (awaiting circulatory death - controlled), kidneys aged 50 years or older on kidney graft function.

Neo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases ;The CHARISMA randomized multicenter clinical trial

The primary study objective is to compare the efficacy, as assessed by overall survival, of surgery and neo-adjuvant chemotherapy to surgery alone in patients with resectable liver metastases of colorectal cancer and a high clinical risk score.…

The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch multicentre cohort study l

The study aim is to decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. Therefore, we investigate whether completion axillary…

A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

To evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

A randomized, single blinded trial to evaluate the efficacy of Imiquimod in women with residual/recurrent Cervical Intraepithelial Neoplasia (CIN) after previous treatment

Primary objectives: Evaluation of the efficacy of imiquimod 5% cream compared to treatment with Large Loop excision of the transformation zone (LLETZ) for recurrent/residual CIN.Secondary objectives: evaluation of the effect of treatments on HPV DNA…

A Randomized Controlled Multicenter Study of an Incisionless Operating Platform for Primary Obesity vs. Diet-Exercise alone: The MILEPOST Study

The primary objective of this study is:* To evaluate the safety and effectiveness of the g-Cath* EZ Delivery Catheter with Snowshoe Suture Anchors* gastric procedure as an weight loss intervention compared to diet and exercise only.A key secondary…

Prospective randomized trial to evaluate and to compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.

1. To evaluate and compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.2. It is still uncertain whether laparoscopic salpingectomy for hydrosalpinx…

Joint distraction (KJD) in treatment of knee osteoarthritis: cartilage changes in a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage changes after KJD and after HTO, based on MRI, radiographs and biomarkers, evaluated 2 years post treatment. 2. To compare clinical efficacy after KJD and after HTO during 2 year follow-up by a questionnaire (KOOS; for pain,…

Primary stability of cemented vs uncemented stems in revision total knee arthroplasty measured with RSA: a randomised controlled trial.

Which technique, cementing or press-fit implanting, of the tibial and femoral stem of the Legion revision total knee prosthesis provides the most primary stability?

A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee

Primary ObjectiveTo demonstrate that the effectiveness of the NOVOCART® 3D plus autologouschondrocyte transplantation system is superior to microfracture for the treatment ofarticular cartilage defects of the knee by demonstrating superiority of the…

Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.

The primary objective of this study is to estimate the effect of endovascular treatment on overall functional outcome after acute ischemic stroke of less than six hour duration, in patients with a symptomatic anterior circulation IAO. The secondary…

Semi-mechanical versus hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for esophageal cancer; the SHARE study

The primary objective of this study is to compare a semi-mechanical with a hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for cancer.

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…

Regenerative surgical treatment of peri-implantosseous defects - a multicenter randomized prospective clinical study

Project description:A controlled randomized multicentre prospective clinical trial of 12 months duration at 5 centres. To evaluate and compare appliance of porous titanium granules (PTG) during surgical treatment of peri-implant osseous defects of…

Randomized Phase III trial comparing immediate versus deferred nephrectomy in
patients with synchronous metastatic renal cell carcinoma.
EORTC 30073 SURTIME

The principal objective of the trial is to investigate whether the sequence of the nephrectomy in patients who receive sunitinib has an effect on patient outcome.

Joint distraction as a treatment for end stage knee osteoarthritis: a comparison with presently applied surgical alternatives.

1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?2. Is KJD superior to HTO in actual structural repair of cartilage?3. Is KJD cost-effective in the long-term compared to HTO and TKP?