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

Recruiting

• Conditions: C19 Malignant neoplasm of rectosigmoid, transition, Incl:Colon with rectumtransition from rectum to sigmoid colon; C19; Malignant neoplasm of rectosigmoid junction

• Registration Number: DRKS00029682
• Lead Sponsor: Johnson & Johnson Medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-29
• Results First Posted: 2023-03-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 528

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>This includes all surgical procedure-related intraoperative and postoperative adverse events which might be expected in colon resection procedures.

Secondary Outcome Measures

Name	Time	Method
- OR Time - from surgical incision to end of suture (min)<br>- Length of hospital stay (days)<br>- 30 day readmission rate (percent)