Mechanical bowel preparation with or without oral antibiotics for rectal resection for cancer (REPCA trial): a study protocol for a multicenter randomized controlled trial.

BACKGROUND: There is still a lack of randomized trials assessing the clinical value of mechanical bowel preparation (MBP) and oral antibiotics (OA) before rectal surgery. Existing studies are inconsistent regarding OA. The aim of this study is to examine the role of MBP with or without OA (using Alfa Normix®) on postoperative complications in patients undergoing rectal resection for cancer. METHODS: We are conducting a prospective multicenter randomized controlled trial comparing MBP (Moviprep®) with OA (Alfa Normix®) versus MBP alone in patients undergoing elective rectal resection for cancer. Patients with rectal or rectosigmoid cancer are randomized in a 1:1 allocation ratio. The primary endpoint is incisional surgical site infection (SSI) assessed within 30 days after surgery. Secondary endpoints are anastomotic leakage (AL), organ/space SSI, other postoperative complications, intraoperative complications, operation time, bowel preparation quality, bowel preparation adherence. Intention-to-treat and per protocol analyses will be performed. CONCLUSIONS: The results of the REPCA trial will demonstrate whether MBP + OA is superior to MBP alone in rectal cancer surgery. This trial might influence current preoperative practice and improve postoperative outcomes.

Uncontrolled donors with controlled reperfusion after sixty minutes of asystole: a novel reliable resource for kidney transplantation.

BACKGROUND: Organ shortage leads to usage of kidneys from donors after sudden cardiac death, or uncontrolled donors (UDCD). Ischemic injury due to cessation of circulation remains a crucial problem that limits adoption of UDCD. Our clinical investigation was to determine the applicability of kidneys obtained from UDCD and resuscitated by extracorporeal perfusion in situ after 60 minutes of asystole. METHODS: In 2009-2011, organ procurement service of St. Petersburg, obtained kidneys from 22 UDCD with critically expanded warm ischemic time (WIT). No patients were considered as potential organ donors initially. All donors died after sudden irreversible cardiac arrest. Mean WIT was 61.4±4.5 minutes. For kidney resuscitation, the subnormothermic extracorporeal abdominal perfusion with thrombolytics and leukocyte depletion was employed. Grafts were transplanted into 44 recipients. The outcomes of transplantation of resuscitated kidneys were compared to outcomes of 87 KTx from 74 brain death donors (BDDs). RESULTS: Immediate functioning of kidney grafts was observed in 21 of the 44 recipients, with no cases of primary non function. By the end of the first post-transplant year there was an acute rejection rate of 9.1% (4 episodes of rejection) in the UDCD group versus 14.2% (13 episodes of rejection) in the BDD group. The actual 1-year graft survival rate was 95.5% (n = 42) in UDCD group, and 94.6% (n = 87) in BDD group. Creatinine levels at the end of the first year were 0.116±0.008 and 0.115±0.004 mmol/l in UDCD and BDD groups, respectively. CONCLUSIONS: UDCD kidneys with critically expanded WIT could be succefully used for transplantation if in situ organ "resuscitation" perfusion is included into procurement protocol. The results of 1-year follow-up meet the generally accepted criteria for graft survival and function. In situ reperfusion may exert a therapeutic effect on grafts before procurement. This approach could substantially expand the organ donors' pool.

Kidney from uncontrolled donors after cardiac death with one hour warm ischemic time: resuscitation by extracorporal normothermic abdominal perfusion "in situ" by leukocytes-free oxygenated blood.

The availability of brain death donors is restricted by many factors. Use of uncontrolled donors after cardiac death could be a promising perspective, but the limiting factor in uncontrolled donation after cardiac death is the warm ischemic time. The purpose of our work was to develop an in situ kidney preservation protocol with application of the extracorporal normothermic abdominal perfusion for organ resuscitation in uncontrolled donors after cardiac death. The main attention was paid to the elimination of leukocytes as the key damaging factor from modified donor oxygenated blood circulating in the device. In 2009, we had 10 uncontrolled donors with warm ischemic time from 45 to 92 min; a normothermic extracorporal perfusion device was applied, providing preservation and restoration of kidney after ischemic damage. In 6 out of 20 kidney recipients, graft function was recovered immediately. All kidney grafts are functioning, and to the end of the third month, the average creatinine was 118.5 ± 19.9 mM. Treatment of ischemically damaged kidney by normothermic extracorporal perfusion with leukocyte depletion before procurement seems to be a challenging protocol for expanding donors' pool and demands further study.

The use of in-situ normothermic extracorporeal perfusion and leukocyte depletion for resuscitation of human donor kidneys.

The unexploited potential of donors after cardiac death is an actual issue for all countries where organ transplantation is performed. The crucial point in uncontrolled donation after cardiac death is the warm ischemic time. The primary purpose of our work was to define the limits of warm ischemic time. Another purpose was the development of an in situ kidney preservation protocol. In 8 uncontrolled donors with warm ischemic time from 45 to 91 minutes, a normothermic extracorporeal perfusion device was applied, providing preservation and restoration of the kidney after ischemic damage. Main attention was paid to the elimination of leukocytes as the key damaging factor from modified donor blood circulating in the device. In 6 out of 16 kidney recipients, graft function was recovered immediately and, by the end of the third month, the average creatinine was 117.9±21.9 mmol/L. Treatment of ischemically damaged kidneys by normothermic extracorporeal perfusion, with leukocyte depletion before procurement, seems to be a challenging protocol and demands further study. Implementation of perfusion systems in organ procurement practice could lead to a partial solution in the organ deficit problem.