Sigmoid DiseasesNCT02636673
Robotic-assisted Versus Laparoscopic Sigmoid Resection
An observational study of Sigmoid Diseases, run by Intuitive Surgical at 6 sites in United States.
Trial summary
Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sigmoid Diseases
- What is being tested?
- Sigmoid Resection
- Type of treatment
- Surgery or procedure
- How many people
- 518 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2015to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects that have undergone robotic-assisted or laparoscopic sigmoid resection for benign and malignant disease will be considered for inclusion except those that had emergency procedures.
Who may be able to join
- All patients that have undergone sigmoid resection for benign or malignant disease
Who cannot join
- Emergency Procedures
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Jackson South Community Hospital
Miami, Florida, 33136
Northern Weschester Hospital
Mount Kisco, New York, 10549
Progressive Surgical Associates/Silver Cross Hospital
New Lenox, Illinois
Aria Health
Phildelphia, Pennsylvania
HonorHealth / Colon & Rectal Clinic of Scottsdale
Scottsdale, Arizona, 85258
St. Joseph's Hospital
Tampa, Florida
About this study
Official title: Robotic-assisted Versus Laparoscopic Sigmoid Resection: a Retrospective Chart Review of Benign and Malignant Sigmoid Disease
Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease
Read the detailed description
The goal is to establish safety and effectiveness of robotic-assisted surgery in sigmoid resection for both benign and malignant disease by evaluation of short-term clinical outcomes through 30 days post index procedure.
- Conditions
- Sigmoid Diseases
- Being tested
- Sigmoid Resection
- Medical subject headings
- Sigmoid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigmoid ResectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted sigmoid resection | Patient that have undergone robotic-assisted sigmoid resection for benign or malignant disease between 2010 and 2015 Receives: Procedure: Sigmoid Resection | |
| Laparoscopic sigmoid resection | Patient that have undergone laparoscopic sigmoid resection for benign or malignant disease between 2010 and 2015 Receives: Procedure: Sigmoid Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications observed intraoperatively through 30-days
Number of complications observed intraoperatively through 30-days
Measured: Intraoperative through 30-days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid DiseasesStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636673
- Sponsor's protocol ID
- ISI-dVSR-001
- Status last verified
- Aug 2016
- First submitted
- 7 Dec 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Versus Laparoscopic Sigmoid Resection: a Retrospective Chart Review of Benign and Malignant Sigmoid Disease
- ClinicalTrials.gov ID
- NCT02636673
- Acronym / sponsor ID
- ISI-dVSR-001
- Conditions
- Sigmoid Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Dec 2015 (estimated)
- 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.
Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease
Detailed description
The goal is to establish safety and effectiveness of robotic-assisted surgery in sigmoid resection for both benign and malignant disease by evaluation of short-term clinical outcomes through 30 days post index procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted sigmoid resection | – | Procedure: Sigmoid ResectionPatient that have undergone robotic-assisted sigmoid resection for benign or malignant disease between 2010 and 2015 |
| Laparoscopic sigmoid resection | – | Procedure: Sigmoid ResectionPatient that have undergone laparoscopic sigmoid resection for benign or malignant disease between 2010 and 2015 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects that have undergone robotic-assisted or laparoscopic sigmoid resection for benign and malignant disease will be considered for inclusion except those that had emergency procedures.
Key inclusion criteria (1 listed)
- All patients that have undergone sigmoid resection for benign or malignant disease
Key exclusion criteria (1 listed)
- Emergency Procedures
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 |
|---|---|---|
| Sigmoid Resection | Procedure or surgery | Laparoscopic sigmoid resection, Robotic-assisted sigmoid resection |
Primary outcome
Number of complications observed intraoperatively through 30-days
Time frame: Intraoperative through 30-days follow-up
Number of complications observed intraoperatively through 30-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sigmoid Diseases, run by Intuitive Surgical at 6 sites 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 1 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: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of complications observed intraoperatively through 30-days (time frame: Intraoperative through 30-days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2016.