AI-enabled robotic stapler versus conventional stapler for colorectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion criteria:

* 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

Exclusion criteria:

* 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)
* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.