Impact of a Digital Surgical Workflow and Digital Device Briefing Tool on Morbidity and Mortality in a Patient Population undergoing Primary Stapled Colorectal Anastomosis for Benign or Malignant Colorectal Disease: A Non-Interventional, Prospective Cohort Study

ABSTRACT: Interventions: Group 1: Patients whose treatment of their benign or malignant colorectal disease by left colorectal surgery with primary stapled colorectal anastomosis is supported by a digital surgical software system (digital surgical workflow on SPI platform) and additionally a new digital product briefing checklist called Digital Device Briefing Tool (DDBT). This product briefing checklist is a newly developed digital cognitive aid for primary stapled colorectal anastomosis called Digital Device Briefing Tool (DDBT). Group 2: Patients whose treatment of their benign or malignant colorectal disease is performed by left colorectal surgery with primary staple anastomosis without digitized surgical OR workflow. Group 3: Patients whose treatment of their benign or malignant colorectal disease by left-sided colorectal surgery with primary staple anastomosis is performed by supported by a digital surgical software system (digital surgical workflow on the SPI platform) without DDBT. Primary outcome(s): The primary endpoint is a composite outcome comprising the overall rate of surgical complications, including death, during hospitalization within the first 30 days after colorectal surgery with primary stapled colorectal anastomosis. For this study, a surgical complication is defined as any deviation from the normal postoperative course, including any undesirable clinical event that may be attributable to the surgical procedure or specifically to the circular stapler used to create the anastomosis and which might be expected in colon resection procedures up till discharge and up to 30-days ofter colorectal surgery. This includes all surgical procedure-related intraoperative and postoperative adverse events which might be expected in colon resection procedures. Study Design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: supportive care

DISEASE(S): Malignant Neoplasm Of Rectosigmoid Junction,Malignant Neoplasm Of Rectosigmoid, Transition, Incl:colon With Rectumtransition From Rectum To Sigmoid Colon

PROVIDER: 2754486 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR