Feasibility and Safety of Single Port Robot in Colorectal Procedures

Rectal Cancer Clinical Trial

Official title:

Feasibility and Safety of Single Port Robot in Colorectal Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03700593
• Other study ID #: F/N-R19-3864L
• Status: Enrolling by invitation
• Start date: October 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Marks Colorectal Surgical Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colon Polyp
• Diverticulitis
• Inflammatory Bowel Diseases
• Polyps
• Prolapse
• Prolapse, Rectal
• Rectal Cancer
• Rectal Polyp
• Rectal Prolapse

Intervention

Device:
• Single Port Robotic Colorectal Surgery
Single Port Robotic Colorectal Surgery

Locations

Country	Name	City	State
United States	Lankenau Medical Center, Marks Colorectal Surgical Associates	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Marks Colorectal Surgical Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the SP robot	Calculating the percentage of cases successfully performed using the SP robot, without conversion.	30 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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