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

Overview

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 .

Interventions

• Device AI-enabled SureForm™ Robotic Stapler
  Use of AI-enabled SureForm™ robotic stapler during robotic-assisted colorectal resections for transection and/or anastomosis creation.
• Device Conventional Laparoscopic Stapler
  Use of standard conventional laparoscopic staplers during laparoscopic colorectal resections for transection and/or anastomosis creation

Primary outcome measures

• Anastomotic leak rates [Time frame: 24 MONTHS]

Secondary outcome measures (1)

• Operative time [Time frame: 24 MONTHS]

Eligibility criteria

Inclusion criteria

A. Subjects, 18 to 90 years B. 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

Exclusion criteria

• A. Emergency Surgery for non-metastatic colorectal cancer B. Subjects who are being treated for recurrent colorectal cancer C. 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 D. Subjects who have perforated, obstructing or locally invasive neoplasm (T4b) E. Subjects who have major concomitant abdominal or pelvic procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with surgery for colorectal cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

India · 1 center

• AIG Hospitals — Hyderabad

Identifiers

NCT: NCT07371832 · STAPLER

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗