An interventional study of Single port robotic colorectal surgical procedure in Colo-rectal Cancer, Rectal Prolapse and Colostomy Stoma, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.
This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform.
AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms.
AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 25 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system
Device: Single port robotic colorectal surgical procedure
After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System). Using standardized case report forms, the investigators will track clinical parameters and describe the safety \& quality event rate for SP platform transabdominal and transanal colorectal operations.
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations
A safety \& quality event will be defined as occurring if any of the following occur: * Conversion to open or laparoscopic procedure * EBL \> 200 ml, or * Operative time \> 90th percentile of all procedures with matching CPT code, or * Positive pathological margins (if applicable), or * Fragmented specimen (if applicable) or * Unplanned ICU stay or * Post-procedure LOS \> 90th percentile of all procedures with matching CPT code, or * Reoperation within 30 days or * Post Procedure Pain \> 90th percentile (visual analog score) * Postoperative complication as defined by NSQIP (including SSI, DVT, PE, readmission, anastomotic Leak (if applicable)
Time frame: 30 days
Plan to share: No
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