Feasibility and Safety of Single Port Robot in Colorectal Procedures

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Rectal Cancer; Diverticulitis; Colon Cancer; Colon Polyp; Rectal Polyp; Prolapse, Rectal
• Intervention / Treatment: Device: Single Port Robotic Colorectal Surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center, Marks Colorectal Surgical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a colorectal pathology requiring a minimally invasive colorectal procedure.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Port Robotic Colorectal Surgery Patients; All patients who undergo a single port robot colorectal surgery.	Device: Single Port Robotic Colorectal Surgery; Single Port Robotic Colorectal Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the SP robot	Calculating the percentage of cases successfully performed using the SP robot, without conversion.	30 days
Rate of postoperative complications and mortality of the SP robot	Measuring the post-operative morbidity and mortality will be used to evaluate the safety of the SP robot.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of patients quality of life using validated questionnaires.	Validated questionnaire will be administered to assess the quality of life of patients: - RAND 36 item Health Survey (by the RAND corporation): All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. This validated questionnaire asks patients to rate their own health and rate their ability to perform a variety of everyday activities using the same scale.	1 year
Assessment of patients' satisfaction with their surgical scars using validated questionnaires.	Validated questionnaire will be administered to assess the patients satisfaction with surgery Patient Scar Assessment Questionnaire (PSAQ)- The PSAQ consists of 5 subscales: Appearance (# of items-9; min-9; max-36), Consciousness (#-6; min-6; max-24), Satisfaction with Appearance (#-8; min-8; max-32) and Satisfaction with Symptoms (#-5; min-5; max-20). Higher scores define more favorable scar appearance, less consciousness of one's scar, increased satisfaction with appearance and symptoms. The scales for each of these subsections is the same; however, min and max scores differ due to differing numbers of questions in each section.	1 year
Assessment of patient's quality of recovery	- Quality of Recovery 40 questionnaire: score range: 40-200. Higher values represent better outcomes. The validate questionnaire measure quality of recovery by evaluating patients' comfort, emotions, physical independence, and support using the same scale.	1 year
Assessment of patients' postoperative body image satisfaction	Body image questionnaire- 13 items total; min score-13 and max score-100. Higher scores correlate to more favorable body image. In reflecting on their own body image, patients are then asked to rate how likely they would be to undergo a laparoscopic, open, versus single port surgery given their experience. These variables are measured on the same scale.	1 year

Collaborators and Investigators

• Sponsor: Marks Colorectal Surgical Associates
• Investigators: Principal Investigator: John H Marks, MD, Main Line Health System / Lankenau Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Single port robotic surgery; Minimally invasive colectomy; Single port robotic colectomy; Single port robotic TEM
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Diverticular Diseases; Pelvic Organ Prolapse; Inflammatory Bowel Diseases; Prolapse; Polyps; Diverticulitis; Rectal Prolapse
• Other Study ID Numbers: F/N-R19-3864L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes