Clinical trial NCT03700593: Feasibility and Safety of Single Port Robot in Colorectal Procedures
Official title: Feasibility and Safety of Single Port Robot in Colorectal Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Colon Polyp
Rectal Cancer
Diverticulitis
Prolapse, Rectal
Rectal Polyp
Inflammatory Bowel Diseases
Keywords: Single port robotic surgery
Minimally invasive colectomy
Single port robotic colectomy
Single port robotic TEM
Lead sponsor: Marks Colorectal Surgical Associates
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a colorectal pathology requiring a minimally invasive colorectal procedure.

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.

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

Primary outcomes:
measure: Feasibility of the SP robot
timeFrame: 30 days
measure: Rate of postoperative complications and mortality of the SP robot
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of patients quality of life using validated questionnaires.
timeFrame: 1 year
measure: Assessment of patients' satisfaction with their surgical scars using validated questionnaires.
timeFrame: 1 year
measure: Assessment of patient's quality of recovery
timeFrame: 1 year
measure: Assessment of patients' postoperative body image satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Lankenau Medical Center, Marks Colorectal Surgical Associates
state: Pennsylvania
Study officials:
affiliation: Main Line Health System / Lankenau Medical Center
name: John H Marks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.