An observational study in Colon Cancer, Colon Polyp and Rectal Cancer, sponsored by Marks Colorectal Surgical Associates. Status unknown at 1 site in United States. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Marks Colorectal Surgical Associates · Observational
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.
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 200 is below the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →This is the only study on the registry with Marks Colorectal Surgical Associates as lead sponsor.
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All patients with a colorectal pathology requiring a minimally invasive colorectal procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients who undergo a single port robot colorectal surgery.
Device: Single Port Robotic Colorectal Surgery
Single Port Robotic Colorectal Surgery
Feasibility of the SP robot
Calculating the percentage of cases successfully performed using the SP robot, without conversion.
Time frame: 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.
Time frame: 30 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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