Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07371832

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

Led by Asian Institute of Gastroenterology, India · Updated on 2026-02-17

200

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 90 years
  • Planned robotic-assisted or laparoscopic surgery for non-metastatic colorectal cancer
  • Use of staplers for transection and/or creation of anastomosis during surgery
Not Eligible

You will not qualify if you...

  • Emergency surgery for non-metastatic colorectal cancer
  • Treatment for recurrent colorectal cancer
  • Need for extensive dissection due to adhesions or advanced cancer that may cause anastomotic leak or bleeding unrelated to stapler
  • Presence of perforated, obstructing, or locally invasive neoplasm (T4b)
  • Planned major additional abdominal or pelvic surgeries such as hepatectomy, hernia repair, nephrectomy, or hysterectomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

AIG Hospitals

Hyderabad, Telangana, India, 500032

Actively Recruiting

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Research Team

D

DR G V RAO, MBBS,MAMS,FRCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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