RECRUITING

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

Conditions

Colo-rectal Cancer Rectal Prolapse Colostomy Stoma Colorectal Disorders robotic surgery colorectal surgery single port Intuitive SP platform

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-28

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05321134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Ankit Sarin, MD

CONTACT

9167034472

axsarin@ucdavis.edu

Pallavi Vaidya, BPharm

CONTACT

9167346609

pmvaidya@ucdavis.edu

Principal Investigator

Ankit Sarin, MD

PRINCIPAL_INVESTIGATOR

University of California, Davis

Study Locations (Sites)

UC Davis Medical Center

Sacramento, California, 95817

United States

Collaborators and Investigators

Sponsor: University of California, Davis

Ankit Sarin, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-28

Study Completion Date2028-04

Study Record Updates

Study Start Date2022-04-28

Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

robotic surgery
colorectal surgery
single port
Intuitive SP platform

Additional Relevant MeSH Terms

Colo-rectal Cancer
Rectal Prolapse
Colostomy Stoma
Colorectal Disorders