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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Apr 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a new type of robotic surgery called the Single Port (SP) platform for patients with colorectal issues, such as colorectal cancer and rectal prolapse. Traditionally, surgeons have used a multiport robotic system, but this study aims to determine how safe and effective the SP technology is for these types of surgeries. The trial is currently recruiting participants who are at least 18 years old and have a documented colorectal diagnosis that requires surgery.

To be eligible for the trial, participants must be in good overall health, able to give informed consent, and agree to follow the study guidelines. They should not be pregnant or breastfeeding, and individuals with severe medical conditions or advanced cancer are excluded from participation. If you join the study, you can expect to undergo a robotic surgery using the SP platform, and researchers will track your recovery and overall health afterward. This trial is important as it may help improve surgical options for patients needing colorectal surgery.

Gender

ALL

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.