Evaluating a new single port robotic approach for colorectal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of a Single Port (SP) Robotic Platform for colorectal surgeries, comparing its safety and effectiveness to the traditional Multi-port (Xi) Robotic Platform. It is a single center, prospective, open-label, investigator-initiated, non-randomized case-control study. Researchers will assess perioperative outcomes from surgeries performed with the SP platform and evaluate the feasibility and quality of these procedures. The aim is to determine if the SP platform can provide a viable alternative for colorectal surgical indications.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC Davis Medical Center
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Ankit Sarin, MD — University of California, Davis
• Study coordinator: Ankit Sarin, MD
• Email: axsarin@ucdavis.edu
• Phone: 9167034472

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.