AI-enabled robotic stapler versus conventional stapler for colorectal cancer surgery
A Single Center Evaluation of AI Enabled SureForm Robotic Stapler (SureformTM) Compared to Conventional Stapler for Colorectal Cancer Procedures
This study will try whether an AI-enabled robotic stapler leads to fewer stapling-related problems than a conventional stapler in adults having planned robotic or laparoscopic surgery for non-metastatic colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT07371832 on ClinicalTrials.gov |
What this trial studies
This is a single-center observational comparison at AIG Hospitals in Hyderabad between the AI-enabled SureForm™ robotic stapler and conventional laparoscopic staplers used during planned colorectal cancer operations. Adults aged 18–90 undergoing robotic-assisted or laparoscopic resection with stapled transection or anastomosis are eligible, while emergency, recurrent, locally invasive (T4b) tumors and cases requiring major concomitant procedures are excluded. Investigators will collect intraoperative stapling performance data and postoperative outcomes such as anastomotic leak, bleeding, stricture, and other adverse events. The goal is to compare real-world device performance and patient outcomes without randomizing participants.
Who should consider this trial
Good fit: Adults 18 to 90 years old scheduled for planned robotic-assisted or laparoscopic surgery for non-metastatic colorectal cancer where staplers will be used, and who do not have emergency, recurrent, or locally invasive disease, are the intended participants.
Not a fit: Patients undergoing emergency surgery, treatment for recurrent disease, with T4b tumors, extensive adhesions, or planned major concomitant abdominal/pelvic procedures are excluded and unlikely to benefit from the comparison.
Why it matters
Potential benefit: If successful, the AI-enabled stapler could reduce stapling errors and lower rates of anastomotic complications like leaks or strictures.
How similar studies have performed: Standard surgical staplers have been shown to perform similarly to hand-sewn anastomoses in many studies, but AI-enabled robotic staplers are relatively new and clinical outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hyderabad, Telangana
- AIG Hospitals — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Principal investigator: Dr G V Rao, Mbbs,mams,frcs — Asian Institute Of Gastroenterology Private Limited
- Study coordinator: Dr G V Rao, Mbbs,mams,frcs
- Email: gvraoaig@gmail.com
- Phone: +91-9182645727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.