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

Sponsor
Ankit Sarin, MD, MHA (Other)
Overall Status
Recruiting
CT.gov ID
NCT05321134
Collaborator
(none)
25
1
1
71.1
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Single port robotic colorectal surgical procedure
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control studySingle center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Actual Study Start Date :
Apr 28, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2028

Arms and Interventions

Arm Intervention/Treatment
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

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.

Outcome Measures

Primary Outcome Measures

  1. Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCSF Medical Center at Mission Bay San Francisco California United States 94158

Sponsors and Collaborators

  • Ankit Sarin, MD, MHA

Investigators

  • Principal Investigator: Ankit Sarin, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ankit Sarin, MD, MHA, Associate Professor, Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05321134
Other Study ID Numbers:
  • 3637342
First Posted:
Apr 11, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Ankit Sarin, MD, MHA, Associate Professor, Surgery, University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022