A Prospective Single-Center Evaluation of SureForm Staplers in Robotic-assisted Colorectal Procedures

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Intuitive Surgical
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Updated on 19 February 2024
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Summary

The primary objective of this study is to evaluate the performance of SureForm Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

Description

This is a prospective, single-center observational study to evaluate the performance of SureForm Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.

The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

Details
Condition Benign Colon Tumor, Malignant Colorectal Tumor, Benign Colorectal Neoplasm
Age 18-100 years
Treatment Colorectal resection
Clinical Study IdentifierNCT04247958
SponsorIntuitive Surgical
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

The subject must be 18 years of age or older at the time of consent
Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureFormStaplers are utilized for transection and/or creation of anastomosis

Exclusion Criteria

Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy
Subject with active bacterial or fungal infection
Subject is contraindicated for general anesthesia or surgery
Subject is undergoing an emergency procedure
Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure
Subject has metastatic disease and/or subject has life expectancy of less than 1 year
Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgical procedure
Subject has history of coagulation or hematologic disorder
Pregnant or suspect pregnancy
The subject is unable to comply with the follow-up visit schedule
Subject has perforated, obstructing or locally invasive neoplasm (T4b)
Subject with inflammatory bowel disease
Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Intra-Operative Exclusion Criteria
Subjects who require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler
Inadequate visualization making an endoscopic approach not feasible
Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
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