Feasibility and Safety of Single Port Robot in Colorectal Procedures

NCT ID: NCT03700593

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2020-12-31

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.

Detailed Description

In the colorectal arena, the robotic approach for benign and malignant disease is well established, with a great deal of literature generated regarding the safety and benefits of a colorectal robotic approach for benign and malignant disease. The section of colorectal surgery at the Lankenau Medical Center has been an active and robust contributor to surgical literature on laparoscopic surgery, robotic colorectal surgery, and single port laparoscopic surgery. Its one investigator has been involved in the development of clinical applications to the single port robotic platform where this has been utilized in cadaver work that has been published. Recently, the SP robot has gone through FDA clearance and is now available for clinical utilization. The FDA approval is for urologic surgery. The SP robot will be utilized in the same fashion to perform the same colorectal operations that the investigators have been performing with multiple port placements in the past to accomplish robotic surgery in a single port platform in the colorectal arena. The principal investigator has worked on the SP robot over the past 3 years with extensive cadaver experience to develop its safe application in the colorectal field. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this, report on the outcomes, and notably answer questions to demonstrate the feasibility and safety of this approach in colorectal patients.

Conditions

Colon Cancer; Colon Polyp; Rectal Cancer; Diverticulitis; Prolapse, Rectal; Rectal Polyp; Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Port Robotic Colorectal Surgery Patients

All patients who undergo a single port robot colorectal surgery.

Single Port Robotic Colorectal Surgery

Intervention Type: DEVICE

Single Port Robotic Colorectal Surgery

Interventions

Single Port Robotic Colorectal Surgery

Single Port Robotic Colorectal Surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study.

Exclusion Criteria

• emergency surgery
• inability to offer informed consent
• pregnant patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marks Colorectal Surgical Associates

OTHER

Sponsor Role: lead

Responsible Party

Dr. John Marks

Chief of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John H Marks, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health System / Lankenau Medical Center

Locations

Lankenau Medical Center, Marks Colorectal Surgical Associates

Wynnewood, Pennsylvania, United States

Countries

United States

References

Marks JH, Agarwal S, Kunkel E, Schoonyoung H, Salem JF. Video Demonstration of an Initial Single-Port Robotic Transanal Total Mesorectal Excision. Dis Colon Rectum. 2021 Aug 1;64(8):e472-e473. doi: 10.1097/DCR.0000000000002139. No abstract available.

Reference Type: DERIVED

PMID: 34001710 (View on PubMed)

Marks JH, Kunkel E, Salem JF, Martin CT, Anderson B, Agarwal S. First Clinical Experience With Single-Port Robotic Transanal Minimally Invasive Surgery: Phase II Trial of the Initial 26 Cases. Dis Colon Rectum. 2021 Aug 1;64(8):1003-1013. doi: 10.1097/DCR.0000000000001999.

Reference Type: DERIVED

PMID: 34001709 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

F/N-R19-3864L

Identifier Type: -

Identifier Source: org_study_id