A Single Center Evaluation of AI Enabled SureForm Robotic Stapler (SureformTM) Compared to Conventional Stapler for Colorectal Cancer Procedures

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorAsian Institute of Gastroenterology, India

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • AI-enabled SureForm™ Robotic Stapler

    Device

    Use of AI-enabled SureForm™ robotic stapler during robotic-assisted colorectal resections for transection and/or anastomosis creation.

  • Conventional Laparoscopic Stapler

    Device

    Use of standard conventional laparoscopic staplers during laparoscopic colorectal resections for transection and/or anastomosis creation

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Robotic-Assisted Surgery Group (Intervention Arm)2 interventions
Group B: Laparoscopic Surgery Group (Comparator Arm)2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From time of surgery through 30 days post-operatively.
2

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.

Time frame
Intra-operative (during the surgical procedure)
3

Other Complications Attributable to Stapler Use

Time frame
From intra-operative procedure through 30 days post-operatively.

Secondary outcomes

1

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.

Time frame
24 MONTHS
2

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).

Time frame
Intra-operative (day of surgery).
3

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.

Time frame
From initiation of surgery through 30 days post-operatively.
4

Rate of Intracorporeal Anastomosis

Proportion of cases where the bowel anastomosis was constructed completely intracorporeally versus extracorporeally.

Time frame
Intra-operative (day of surgery)

Other outcomes

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