Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Single port robotic colorectal surgical procedure
DeviceAfter 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Single Port Robotic Surgery ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations
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)
Time frame
30 daysSponsors and contacts
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University of California, Davis
Lead sponsor
University of California, San Francisco
Collaborator
Yale University
Collaborator
Henry Ford Hospital
Collaborator
University of Massachusetts, Worcester
Collaborator
Source ClinicalTrials.gov