Added Value of 3D-vision During Biotissue Robotic Pancreatoduodenectomy Anastomoses (LAEBOT-3D2D): a Randomized Controlled Cross-Over Trial

Abstract Background Pancreatoduodenectomy is a complex and challenging procedure that requires meticulous tissue dissection and proficient suturing skills. Minimally invasive surgery with the utilization of robotic platforms has demonstrated advantages in perioperative patient outcomes in retrospective studies. The development of robotic pancreatoduodenectomy (RPD) in specific has progressed significantly, since first reported in 2003, and high-volume centers in pancreatic surgery are reporting large patient series with improved pain management and reduced length of stay. However, prospective studies to assess objectively the feasibility and safety of RPD compared to open pancreatoduodenectomy (OPD) are currently lacking. Methods/design The PORTAL trial is a multicenter randomized controlled, patient-blinded, parallel-group, phase III non-inferiority trial performed in seven high-volume centers for pancreatic and robotic surgery in China (> 20 RPD and > 100 OPD annually in each participating center). The trial is designed to enroll and randomly assign 244 patients with an indication for elective pancreatoduodenectomy for malignant periampullary and pancreatic lesions, as well as premalignant and symptomatic benign periampullary and pancreatic disease. The primary outcome is time to functional recovery postoperatively, measured in days. Secondary outcomes include postoperative morbidity and mortality, as well as perioperative costs. A sub-cohort of 128 patients with pancreatic adenocarcinoma (PDAC) will also be compared to assess the percentage of patients who undergo postoperative adjuvant chemotherapy within 8 weeks, in each arm. Secondary outcomes in this cohort will include patterns of disease recurrence, recurrence-free survival, and overall survival. Discussion The PORTAL trial is designed to assess the feasibility and safety of RPD compared to OPD, in terms of functional recovery as described previously. Additionally, this trial will explore whether RPD allows increased access to postoperative adjuvant chemotherapy, in a sub-cohort of patients with PDAC. Trial registration ClinicalTrials.govNCT04400357. Registered on May 22, 2020

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The NUTRAOLEOUM Study, a randomized controlled trial, for achieving nutritional added value for olive oils

BMC Complementary and Alternative Medicine ◽

10.1186/s12906-016-1376-6 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 5

Author(s):

Sara Biel ◽

Maria-Dolores Mesa ◽

Rafael de la Torre ◽

Juan-Antonio Espejo ◽

Jose-Ramón Fernández-Navarro ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Added Value ◽

Olive Oils ◽

Randomized Controlled

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No added value for Computer-Assisted surgery to improve femoral component positioning and Patient Reported Outcomes in Hip Resurfacing Arthroplasty; a multi-center randomized controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/s12891-019-2883-7 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

M. C. Koper ◽

M. Reijman ◽

E. M. van Es ◽

J. H. Waarsing ◽

H. W. J. Koot ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Femoral Component ◽

Controlled Trial ◽

Computer Assisted Surgery ◽

Hip Resurfacing ◽

Added Value ◽

Computer Assisted ◽

Hip Resurfacing Arthroplasty ◽

Resurfacing Arthroplasty ◽

Randomized Controlled

Abstract Background Computer Assisted Surgery (CAS) has proven to improve the accuracy in several orthopedic procedures. Therefore we used this technique to evaluate femoral component positioning in Hip Resurfacing Arthroplasty (HRA). The aim of this study was to evaluate imageless CAS compared to manually implanted femoral components and subsequently evaluates Patient Related Outcome Measures (PROMs). We hypothesized that the use of CAS optimizes the position of the femoral component and improves PROMs. Methods This is a multicenter, single-blinded, randomized, controlled trial of two groups. In the CAS group guiding of the femoral component was done with imageless navigation. In the Conventional (control) group the femoral component was placed manually according to the preplanned position. The primary outcome measure consists of a maximum of 3 degrees difference between the postoperative Stem Shaft Angle (SSA) and preplanned SSA. Secondary outcome measures consist of the Hip disability and Osteoarthritis Outcome Scale (HOOS), the Harris Hip Score (HHS) and Visual Analogue Scale (VAS) pain score. Results A total of 122 patients were randomized, 61 in the CAS group and 61 in the conventional group. There was no significant differences in accuracy of femoral implant position. The mean difference between the postoperative- and preplanned SSA was − 2.26 and − 1.75 degrees (more varus) respectively in the CAS and Conventional group. After surgery both groups show significant improvement in all PROMs compared to the baseline measurements, with no significant differences between the groups. Conclusion Our cohort indicates no benefit for the use of CAS in accuracy of placement of the femoral component in HRA compared to manual implantation. There are no clinical differences in PROMs after 1 year follow up. This study showed no added value and no justification for the use of CAS in femoral component positioning in HRA. Trial registration This trial is registered at ClinicalTrails.gov (https://clinicaltrials.gov/) on the 25th of October 2006: NCT00391937. Level of incidence Level IIb, multicenter randomized controlled trial.

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