RecruitingNCT07371832

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


Sponsor

Asian Institute of Gastroenterology, India

Enrollment

200 participants

Start Date

Feb 5, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing an AI-assisted robotic surgical stapler (SureForm) with standard surgical staplers to see whether the AI-enabled tool leads to fewer complications — such as leaks or bleeding — during colorectal cancer surgery. **You may be eligible if...** - You are between 18 and 90 years old - You are scheduled for robotic-assisted or laparoscopic (minimally invasive) surgery for non-metastatic colorectal cancer - Your surgery will use a stapler to cut or reconnect the bowel **You may NOT be eligible if...** - Your surgery is an emergency - You are being treated for recurrent (returned) colorectal cancer - You have cancer that has extensively grown into surrounding tissues or has perforated the bowel - You require another major abdominal or pelvic procedure at the same time as your colorectal surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAI-enabled SureForm™ Robotic Stapler

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

DEVICEConventional Laparoscopic Stapler

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


Locations(1)

AIG Hospitals

Hyderabad, Telangana, India

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NCT07371832


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