Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

• ClinicalTrials.gov Identifier: NCT05321134
• Recruitment Status: Recruiting
• First Posted: April 11, 2022
• Last Update Posted: May 13, 2024
• Sponsor: Ankit Sarin
• Collaborators: University of California, San Francisco; Yale University; Henry Ford Hospital; University of Massachusetts, Worcester
• Information provided by (Responsible Party): Ankit Sarin, University of California, Davis

Tracking Information

• First Submitted Date: March 31, 2022
• First Posted Date: April 11, 2022
• Last Update Posted Date: May 13, 2024
• Actual Study Start Date: April 28, 2022
• Estimated Primary Completion Date: April 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2022)

Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations [ Time Frame: 30 days ]

A safety & quality event will be defined as occurring if any of the following occur:

• Conversion to open or laparoscopic procedure
• EBL > 200 ml, or
• Operative time > 90th percentile of all procedures with matching CPT code, or
• Positive pathological margins (if applicable), or
• Fragmented specimen (if applicable) or
• Unplanned ICU stay or
• Post-procedure LOS > 90th percentile of all procedures with matching CPT code, or
• Reoperation within 30 days or
• Post Procedure Pain > 90th percentile (visual analog score)
• Postoperative complication as defined by NSQIP (including SSI, DVT, PE, readmission, anastomotic Leak (if applicable)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
• Official Title: Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
• Brief Summary: Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

Detailed Description

This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform.

AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms.

AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Colo-rectal Cancer
• Rectal Prolapse
• Colostomy Stoma
• Colorectal Disorders

Intervention

Device: Single port robotic colorectal surgical procedure

After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System).

Using standardized case report forms, the investigators will track clinical parameters and describe the safety & quality event rate for SP platform transabdominal and transanal colorectal operations.

Study Arms

Experimental: Single Port Robotic Surgery Arm

Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system

Intervention: Device: Single port robotic colorectal surgical procedure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 8, 2022): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2028
• Estimated Primary Completion Date: April 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• The subject is male or female, greater than or equal to 18 years of age. If female, the subject has a negative urine pregnancy test and is not lactating, or has not been of childbearing potential for at least 3 months prior to use of study product. To be considered to be not of childbearing potential, the subject must be postmenopausal for at least 2 years; have had a hysterectomy or bilateral tubal ligation, or be proven to be otherwise incapable of pregnancy. If of childbearing potential, the subject must have been practicing one of the following methods of contraception consistently for at least 1 month prior to study entry and agree to continue practicing it during the study: hormonal contraceptives, intrauterine device, spermicide and barrier, spouse/partner sterility; or is practicing abstinence and agrees to continue abstinence or to start an acceptable method of contraception from the above list if sexual activity commences.
• There is documentation of a colorectal diagnosis requiring operative interventions with clinical plans for a robotic operation.
• For robotic transanal procedures, patients who would meet standard guidelines for a transanal procedures (T1N0 rectal adenocarcinoma, Precancerous adenomas, and localized neuroendocrine tumors) distal to 15 cm from the anal verge.
• The subject is in good general health as evidenced by medical history and physical examination
• The subject is able and willing to provide written informed consent.
• The subject agrees to comply with the requirements of the protocol and complete study measures.
• The subject has stable residence and telephone.

Exclusion Criteria:

• The subject is child less than 18 years of age
• The subject is a female who is pregnant or lactating
• The subject falls under the American Society of Anesthesia Class IV (Patients with severe systemic disease that is a constant threat to life).
• The subject falls under American Society of Anesthesia Class V (Moribund patients who is not expected to survive without the operation)
• The subject has a history of clinically significant renal, hepatic, neurological, cardiac or chronic pulmonary disease that in the judgment of the investigator precludes participation.
• The subject has advanced/ Stage IV cancer
• The subject has received neo-adjuvant chemotherapy or radiation therapy
• The subject requires an emergency operation.
• The subject is unable to fully comprehend or consent to the study
• The subject is unwilling to be available for follow-up assessments.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ankit Sarin, MD; 9167034472; axsarin@ucdavis.edu

Contact: Pallavi Vaidya, BPharm; 9167346609; pmvaidya@ucdavis.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05321134
• Other Study ID Numbers: 3637342
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ankit Sarin, University of California, Davis
• Original Responsible Party: Ankit Sarin, MD, MHA, University of California, San Francisco, Associate Professor, Surgery
• Current Study Sponsor: Ankit Sarin
• Original Study Sponsor: Ankit Sarin, MD, MHA

Collaborators

• University of California, San Francisco
• Yale University
• Henry Ford Hospital
• University of Massachusetts, Worcester

Investigators

• Principal Investigator: Ankit Sarin, MD; University of California, Davis

• PRS Account: University of California, Davis
• Verification Date: May 2024