Colon CancerNCT03700593
Feasibility and Safety of Single Port Robot in Colorectal Procedures
An observational study of Colon Cancer and Colon Polyp, run by Marks Colorectal Surgical Associates at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Colon Polyp, Rectal Cancer
- What is being tested?
- Single Port Robotic Colorectal Surgery
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 31 Dec 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with a colorectal pathology requiring a minimally invasive colorectal procedure.
Who may be able to join
- All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study.
Who cannot join
- emergency surgery
- inability to offer informed consent
- pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Lankenau Medical Center, Marks Colorectal Surgical Associates
Wynnewood, Pennsylvania, 19096
About this study
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.
Read the 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
- Being tested
- Single Port Robotic Colorectal Surgery
- Keywords
- Single port robotic surgery, Minimally invasive colectomy, Single port robotic colectomy, Single port robotic TEM
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps, Rectal Neoplasms, Diverticulitis, Rectal Prolapse, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Port Robotic Colorectal SurgeryDevice
Single Port Robotic Colorectal Surgery
| Study group | Role | What they receive |
|---|---|---|
| Single Port Robotic Colorectal Surgery Patients | All patients who undergo a single port robot colorectal surgery. Receives: Device: Single Port Robotic Colorectal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the SP robot
Calculating the percentage of cases successfully performed using the SP robot, without conversion.
Measured: 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.
Measured: 30 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Oct 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Marks Colorectal Surgical Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. John Marks, Marks Colorectal Surgical Associates
- Investigators
- John H Marks, MD, Principal investigator, Main Line Health System / Lankenau Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700593
- Sponsor's protocol ID
- F/N-R19-3864L
- Status last verified
- Feb 2020
- First submitted
- 2 Oct 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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. No abstract available.
PubMed 34001710Marks 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.
PubMed 34001709
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Single Port Robot in Colorectal Procedures
- ClinicalTrials.gov ID
- NCT03700593
- Acronym / sponsor ID
- F/N-R19-3864L
- Conditions
- Colon Cancer, Colon Polyp, Rectal Cancer, Diverticulitis, Prolapse, Rectal, Rectal Polyp
- Keywords
- Single port robotic surgery, Minimally invasive colectomy, Single port robotic colectomy, Single port robotic TEM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Marks Colorectal Surgical AssociatesUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Port Robotic Colorectal Surgery Patients | – | Device: Single Port Robotic Colorectal SurgeryAll patients who undergo a single port robot colorectal surgery. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a colorectal pathology requiring a minimally invasive colorectal procedure.
Key inclusion criteria (1 listed)
- All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study.
Key exclusion criteria (3 listed)
- emergency surgery
- inability to offer informed consent
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Port Robotic Colorectal SurgerySingle Port Robotic Colorectal Surgery | Device | Single Port Robotic Colorectal Surgery Patients |
Primary outcome
Feasibility of the SP robot
Time frame: 30 days
Calculating the percentage of cases successfully performed using the SP robot, without conversion.
Rate of postoperative complications and mortality of the SP robot
Time frame: 30 days
Measuring the post-operative morbidity and mortality will be used to evaluate the safety of the SP robot.
4 secondary outcomes
Assessment of patients quality of life using validated questionnaires.
Time frame: 1 year
Assessment of patients' satisfaction with their surgical scars using validated questionnaires.
Time frame: 1 year
Assessment of patient's quality of recovery
Time frame: 1 year
Assessment of patients' postoperative body image satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 34001710Marks 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.
- Derived from this study: PubMed 34001709Marks 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.
- Individual participant dataSharing planned: No
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John H Marks, MD principal investigator
Main Line Health System / Lankenau Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Colon Polyp, run by Marks Colorectal Surgical Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the SP robot (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700593, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.