C19 Malignant neoplasm of rectosigmoid, transition, Incl: Colon with rectumtransition from rectum to sigmoid colon C19
Conditions
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 sy
Sponsors
Johnson & Johnson Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients satisfying the following criteria will be considered eligible for enrollment in this study: - Undergoing left hemi-colectomy, sigmoidectomy, anterior rectal resection or Hartman Reversal operation for benign or malignant pathology in which the Ethicon circular stapler (CDH/B) is planned to be used for stapled colorectal anastomosis. - All standard surgical techniques of the clinical sites (open, laparoscopic, robotic) can be used during the study execution. - Willingness to give consent and comply with all study-related evaluations and visit schedule. - At least 18 years of age.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be considered ineligible for enrollment or analysis in this study: a) Preoperative - Physical or psychological condition which would impair study participation. - The procedure is a revision/reoperation for the same indication or same anatomical location. - The procedure is an urgent or emergency colorectal surgery. b) Intraoperative - Nonrestorative surgery (anastomosis not made) - Study device (Ethicon circular stapler CDH/B) not attempted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - OR Time - from surgical incision to end of suture (min) - Length of hospital stay (days) - 30 day readmission rate (percent) | — |
Countries
Germany
Contacts
Public ContactJohannes Christian Lauscher;Ute Lauscher;Schöber
Charité Campus Benjamin Franklin;Clinische Studien Gesellschaft mbH
Outcome results
None listed