Secondary Peritonitis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
AIG Hospitals
RECRUITING
Hyderabad
Contact Information
Primary
DR G V RAO, MBBS,MAMS,FRCS
gvraoaig@gmail.com
+91-9182645727
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 200
Treatments
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.
Laparoscopic Surgery Group (Comparator Arm)
Subjects undergoing laparoscopic colorectal cancer surgery using conventional laparoscopic staplers for bowel transection and/or creation of anastomosis.
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov