About this trial
Robotic-assisted surgeries are especially valuable for colorectal pathologies because they offer better vision and control for surgical manipulation given the narrow operative region within the pelvis .Some of the iatrogenic risk factors associated with higher post-operative adverse events following colorectal surgeries are surgeon experience' and hospital case load'. In order to mitigate these factors, surgical staplers have gained preference amongst surgeons due to their reproducible results and ease of learning At present there are only two methods of creating an anastomosis: hand-sewn technique using sutures or surgical staplers. Surgical staplers have been shown to be as effective as hand-sewn techniques for colorectal anastomoses However, anastomotic strictures can be bothersome for patients and the rate of stricture is fourfold higher for stapled anastomoses than for those that are hand sewn in colorectal anastomoses . Additionally, overzealous or incorrect stapling could also result in hemostasis or ischemia One of the most dreaded adverse events of colorectal resection is anastomotic leakages followed, in decreasing severity, by post-operative bleeding and ileus. Because of the severity of adverse events associated with an anastomotic leak, it is important to detect it early and provide early management for the same. However, diagnosis of anastomotic leakage is commonly a symptomatic diagnosis based on development of gas, purulent or fecal discharge from the drain, purulent discharge from the rectum, pelvic abscess or peritonitis. Such severe symptoms further complicate the post-operative recovery and lengthen the hospital stay. Interestingly, it has been
reported that anastomotic leaks were more often diagnosed late in the postoperative period and more often after hospital discharge, or 12 days postoperatively . Anastomotic leakage rates vary from the colon to the rectum, with much higher rates in the rectum. Because of the severity of adverse events associate with an anastomotic leak, there is a pressing need for new techniques for prevention of anastomotic leakages .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is 18 to 85 years of age
Subjects who will undergo Planned robotic-assisted surgery or laparoscopic surgery (as the primary treatment) for non-metastatic colorectal cancer where staplers are utilized for transection and/or creation of anastomosis
Disqualifiers
Emergency Surgery for non-metastatic colorectal cancer
Subjects who are being treated for recurrent colorectal cancer
Subjects who will require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler
Subjects who have perforated, obstructing or locally invasive neoplasm (T4b)
Trial population
200
Trial design
Cohort
Prospective
Treatments tested in this trial
AI-enabled SureForm™ Robotic Stapler
DeviceUse of AI-enabled SureForm™ robotic stapler during robotic-assisted colorectal resections for transection and/or anastomosis creation.
Conventional Laparoscopic Stapler
DeviceUse of standard conventional laparoscopic staplers during laparoscopic colorectal resections for transection and/or anastomosis creation
Treatment groups
Trial outcomes
Primary outcomes
Anastomotic leak rate
Percentage of participants diagnosed with an anastomotic leakage (confirmed clinically by gas, purulent/fecal discharge from the drain/rectum, pelvic abscess, peritonitis, or via radiological imaging/reoperation) following colorectal resection
Percentage of Participants Requiring a Surgical Stapler Articulation Angle Greater Than 45 Degrees
Proportion of participants in whom surgical transection required a robotic wrist articulation angle exceeding 45 degrees (calculated as resultant 3D vector articulation: square root of pitch squared plus yaw squared). Additional telemetry parameters recorded include mean pitch and yaw angles, number of clamping attempts, and successful firing completion rates.
Other Complications Attributable to Stapler Use
Secondary outcomes
Operative time
Operative time is defined as the total duration of the surgical procedure, measured in minutes, from skin incision to completion of skin closure.
Increase in Operative Time Due to Stapling Complications
Additional intra-operative time (in minutes) expended specifically to manage, troubleshoot, or repair staple-line-related issues or device malfunctions (such as over-sewing bleeding staple lines, applying hemostatic sealants, or redoing an anastomosis).
Intraoperative and Postoperative Adverse Events
Rate and severity of procedure-related complications categorized according to the Clavien-Dindo classification system, including requirements for intra-operative or post-operative blood transfusion.
Rate of Intracorporeal Anastomosis
Proportion of cases where the bowel anastomosis was constructed completely intracorporeally versus extracorporeally.
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