Colorectal CancerNCT07371832
A Single Center Evaluation of AI Enabled SureForm Robotic Stapler (SureformTM) Compared to Conventional Stapler for Colorectal Cancer Procedures
An observational study of Colorectal Cancer, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- AI-enabled SureForm™ Robotic Stapler and Conventional Laparoscopic Stapler
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jan 2026to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AIG Hospitals
Hyderabad, Telangana, 500032
Sana Fathima, 9182859523, aigresearch7@gmail.com
About this study
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
- Colorectal Cancer
- Being tested
- AI-enabled SureForm™ Robotic Stapler, Conventional Laparoscopic Stapler
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled SureForm™ Robotic StaplerDevice
Use of AI-enabled SureForm™ robotic stapler during robotic-assisted colorectal resections for transection and/or anastomosis creation.
Conventional Laparoscopic StaplerDevice
Use of standard conventional laparoscopic staplers during laparoscopic colorectal resections for transection and/or anastomosis creation
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Surgery Group (Intervention Arm) | Subjects undergoing robotic-assisted colorectal cancer surgery where AI-enabled SureForm™ Robotic.Stapler is used for bowel transection and/or creation of anastomosis. Receives: Device: AI-enabled SureForm™ Robotic Stapler; Device: Conventional Laparoscopic Stapler | |
| Laparoscopic Surgery Group (Comparator Arm) | Subjects undergoing laparoscopic colorectal cancer surgery using conventional laparoscopic staplers for bowel transection and/or creation of anastomosis. Receives: Device: AI-enabled SureForm™ Robotic Stapler; Device: Conventional Laparoscopic Stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak rate
Percentage of participants diagnosed with an anastomotic leakage (confirmed clinically by gas, purulent/fecal discharge from the drain/rectum, pelvic abscess, peritonitis, or via radiological imaging/reoperation) following colorectal resection
Measured: From time of surgery through 30 days post-operatively.
Percentage of Participants Requiring a Surgical Stapler Articulation Angle Greater Than 45 Degrees
Proportion of participants in whom surgical transection required a robotic wrist articulation angle exceeding 45 degrees (calculated as resultant 3D vector articulation: square root of pitch squared plus yaw squared). Additional telemetry parameters recorded include mean pitch and yaw angles, number of clamping attempts, and successful firing completion rates.
Measured: Intra-operative (during the surgical procedure)
Other Complications Attributable to Stapler Use
Measured: From intra-operative procedure through 30 days post-operatively.
Secondary outcomes (16)
Operative time
Operative time is defined as the total duration of the surgical procedure, measured in minutes, from skin incision to completion of skin closure.
Measured: 24 MONTHS
Increase in Operative Time Due to Stapling Complications
Additional intra-operative time (in minutes) expended specifically to manage, troubleshoot, or repair staple-line-related issues or device malfunctions (such as over-sewing bleeding staple lines, applying hemostatic sealants, or redoing an anastomosis).
Measured: Intra-operative (day of surgery).
Intraoperative and Postoperative Adverse Events
Rate and severity of procedure-related complications categorized according to the Clavien-Dindo classification system, including requirements for intra-operative or post-operative blood transfusion.
Measured: From initiation of surgery through 30 days post-operatively.
Rate of Intracorporeal Anastomosis
Proportion of cases where the bowel anastomosis was constructed completely intracorporeally versus extracorporeally.
Measured: Intra-operative (day of surgery)
Surgical Conversion Rate
Percentage of minimally invasive procedures (robotic or laparoscopic) converted to an unplanned open laparotomy or hand-assisted approach.
Measured: Intra-operative (day of surgery).
Conversion Rate Due to Stapling-Related Complications
Percentage of conversions to open surgery or hand-assisted techniques directly resulting from stapler misfires, device failure, or intractable staple-line failure.
Measured: Intra-operative (day of surgery)
Length of ICU Stay
Total duration of intensive care unit admission recorded in continuous days.
Measured: From immediate post-operative transfer until discharge from the ICU (assessed up to 30 days post-surgery).
Increase in ICU Stay Due to Stapling Complications
Additional days spent in the intensive care unit directly attributable to the management and recovery from staple-line leaks, bleeding, or reinterventions.
Measured: From immediate post-operative period through hospital discharge (assessed up to 30 days post-surgery).
Total Length of Hospital Stay
Measured: From date of surgery through index hospital discharge (assessed up to 30 days post-surgery).
Increase in Hospital Stay Due to Stapling Complications
Measured: Through index hospital discharge (assessed up to 30 days post-surgery).
Resection Margin Positivity Rate
Measured: Through final histopathology reporting (typically within 14 to 30 days post-surgery).
Percentage of Participants With Complete Mesorectal Excision Quality Graded by Quirke Classification
Measured: Through final histopathology reporting (typically within 14 to 30 days post-surgery).
Number of Regional Lymph Nodes Harvested per Participant
Total count of regional lymph nodes harvested and histopathologically examined from the resected colorectal surgical specimen. Data will be reported as the mean or median number of lymph nodes retrieved per participant.
Measured: Through final histopathology reporting (typically within 14 to 30 days post-surgery).
30-Day Hospital Readmission Rate
Measured: From hospital discharge up to 30 days post-surgery.
30-Day Reoperation Rate
Measured: From completion of surgery through 30 days post-surgery.
Time to Initiation of Adjuvant Therapy
Measured: From date of surgery up to 30 days post-surgery (or standard post-operative follow-up window).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start19 Jan 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- DR G V RAO, MBBS,MAMS,FRCS, Principal investigator, Asian Institute Of Gastroenterology Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371832
- Sponsor's protocol ID
- STAPLER
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Evaluation of AI Enabled SureForm Robotic Stapler (SureformTM) Compared to Conventional Stapler for Colorectal Cancer Procedures
- ClinicalTrials.gov ID
- NCT07371832
- Acronym / sponsor ID
- STAPLER
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Surgery Group (Intervention Arm) | – | Device: AI-enabled SureForm™ Robotic Stapler, Device: Conventional Laparoscopic StaplerSubjects undergoing robotic-assisted colorectal cancer surgery where AI-enabled SureForm™ Robotic.Stapler is used for bowel transection and/or creation of anastomosis. |
| Laparoscopic Surgery Group (Comparator Arm) | – | Device: AI-enabled SureForm™ Robotic Stapler, Device: Conventional Laparoscopic StaplerSubjects undergoing laparoscopic colorectal cancer surgery using conventional laparoscopic staplers for bowel transection and/or creation of anastomosis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-enabled SureForm™ Robotic StaplerUse of AI-enabled SureForm™ robotic stapler during robotic-assisted colorectal resections for transection and/or anastomosis creation. | Device | Laparoscopic Surgery Group (Comparator Arm), Robotic-Assisted Surgery Group (Intervention Arm) |
| Conventional Laparoscopic StaplerUse of standard conventional laparoscopic staplers during laparoscopic colorectal resections for transection and/or anastomosis creation | Device | Laparoscopic Surgery Group (Comparator Arm), Robotic-Assisted Surgery Group (Intervention Arm) |
Primary outcome
Anastomotic leak rate
Time frame: From time of surgery through 30 days post-operatively.
Percentage of participants diagnosed with an anastomotic leakage (confirmed clinically by gas, purulent/fecal discharge from the drain/rectum, pelvic abscess, peritonitis, or via radiological imaging/reoperation) following colorectal resection
Percentage of Participants Requiring a Surgical Stapler Articulation Angle Greater Than 45 Degrees
Time frame: Intra-operative (during the surgical procedure)
Proportion of participants in whom surgical transection required a robotic wrist articulation angle exceeding 45 degrees (calculated as resultant 3D vector articulation: square root of pitch squared plus yaw squared). Additional telemetry parameters recorded include mean pitch and yaw angles, number of clamping attempts, and successful firing completion rates.
Other Complications Attributable to Stapler Use
Time frame: From intra-operative procedure through 30 days post-operatively.
16 secondary outcomes
Operative time
Time frame: 24 MONTHS
Increase in Operative Time Due to Stapling Complications
Time frame: Intra-operative (day of surgery).
Intraoperative and Postoperative Adverse Events
Time frame: From initiation of surgery through 30 days post-operatively.
Rate of Intracorporeal Anastomosis
Time frame: Intra-operative (day of surgery)
Surgical Conversion Rate
Time frame: Intra-operative (day of surgery).
Conversion Rate Due to Stapling-Related Complications
Time frame: Intra-operative (day of surgery)
Length of ICU Stay
Time frame: From immediate post-operative transfer until discharge from the ICU (assessed up to 30 days post-surgery).
Increase in ICU Stay Due to Stapling Complications
Time frame: From immediate post-operative period through hospital discharge (assessed up to 30 days post-surgery).
Total Length of Hospital Stay
Time frame: From date of surgery through index hospital discharge (assessed up to 30 days post-surgery).
Increase in Hospital Stay Due to Stapling Complications
Time frame: Through index hospital discharge (assessed up to 30 days post-surgery).
Resection Margin Positivity Rate
Time frame: Through final histopathology reporting (typically within 14 to 30 days post-surgery).
Percentage of Participants With Complete Mesorectal Excision Quality Graded by Quirke Classification
Time frame: Through final histopathology reporting (typically within 14 to 30 days post-surgery).
Number of Regional Lymph Nodes Harvested per Participant
Time frame: Through final histopathology reporting (typically within 14 to 30 days post-surgery).
30-Day Hospital Readmission Rate
Time frame: From hospital discharge up to 30 days post-surgery.
30-Day Reoperation Rate
Time frame: From completion of surgery through 30 days post-surgery.
Time to Initiation of Adjuvant Therapy
Time frame: From date of surgery up to 30 days post-surgery (or standard post-operative follow-up window).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DR G V RAO, MBBS,MAMS,FRCS principal investigator
Asian Institute Of Gastroenterology Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DR G V RAO, MBBS,MAMS,FRCS (+91-9182645727, gvraoaig@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak rate (time frame: From time of surgery through 30 days post-operatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.