Colonic NeoplasmsNCT03019016
Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
An observational study of Colonic Neoplasms and Crohn Disease, run by Intuitive Surgical.
Trial summary
The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms, Crohn Disease
- What is being tested?
- Right Colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Oct 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age ≥ 18 years Patients with benign or malignant right colon disease Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon
Who may be able to join
- Age ≥ 18 years
- Patients with benign or malignant right colon disease
- Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon
Who cannot join
- Patients with perforated, obstructing or locally invasive neoplasm (T4b)
- Emergency procedures
- Patients undergoing right colectomy as a secondary procedure
- Patients undergoing radiation therapy for malignant neoplasia before and after procedure
About this study
Official title: A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease.
The secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.
Read the detailed description
This is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating Institution/Investigator and IRB approval has been obtained.
It is anticipated that the retrospective chart review will span the period between January 1, 2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA). Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.
- Conditions
- Colonic Neoplasms, Crohn Disease
- Being tested
- Right Colectomy
- Medical subject headings
- Colonic Neoplasms, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right ColectomyProcedure or surgery
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
| Study group | Role | What they receive |
|---|---|---|
| Robotic RC (IA) | Benign or malignant disease under going a right colectomy. Receives: Procedure: Right Colectomy | |
| Robotic RC (EA) | Patients with benign or malignant disease under going a right colectomy. Receives: Procedure: Right Colectomy | |
| Laparoscopic RC (IA) | Patients with benign or malignant disease under going a right colectomy. Receives: Procedure: Right Colectomy | |
| Laparoscopic RC (EA) | Patients with benign or malignant disease under going a right colectomy. Receives: Procedure: Right Colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart review on PeriOperative Information
Number of complications observed intraoperatively through 30-days
Measured: Intraoperative through 30-days follow-up
Secondary outcomes (1)
Chart review on Postoperative Information
Number of complications observed postoperatively through 6 month
Measured: Postoperative through 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shilpa Mehendale, Study director, Sr Director, Clinical Affairs, Intuitive Surgical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019016
- Sponsor's protocol ID
- ISI-dVRC-001
- Status last verified
- Oct 2017
- First submitted
- 29 Aug 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
- ClinicalTrials.gov ID
- NCT03019016
- Acronym / sponsor ID
- ISI-dVRC-001
- Conditions
- Colonic Neoplasms, Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 12 Jan 2017 (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.
The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease.
The secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.
Detailed description
This is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating Institution/Investigator and IRB approval has been obtained.
It is anticipated that the retrospective chart review will span the period between January 1, 2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA). Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Robotic RC (IA) | – | Procedure: Right ColectomyBenign or malignant disease under going a right colectomy. |
| Robotic RC (EA) | – | Procedure: Right ColectomyPatients with benign or malignant disease under going a right colectomy. |
| Laparoscopic RC (IA) | – | Procedure: Right ColectomyPatients with benign or malignant disease under going a right colectomy. |
| Laparoscopic RC (EA) | – | Procedure: Right ColectomyPatients with benign or malignant disease under going a right colectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥ 18 years Patients with benign or malignant right colon disease Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with benign or malignant right colon disease
- Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon
Key exclusion criteria (4 listed)
- Patients with perforated, obstructing or locally invasive neoplasm (T4b)
- Emergency procedures
- Patients undergoing right colectomy as a secondary procedure
- Patients undergoing radiation therapy for malignant neoplasia before and after procedure
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 |
|---|---|---|
| Right ColectomyRobotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon. | Procedure or surgery | Laparoscopic RC (EA), Laparoscopic RC (IA), Robotic RC (EA), Robotic RC (IA) |
Primary outcome
Chart review on PeriOperative Information
Time frame: Intraoperative through 30-days follow-up
Number of complications observed intraoperatively through 30-days
1 secondary outcome
Chart review on Postoperative Information
Time frame: Postoperative through 6 month follow-up
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 26 Oct 2017.
- Individual participant dataSharing planned: Yes
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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.
Shilpa Mehendale study director
Sr Director, Clinical Affairs, Intuitive Surgical, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasms and Crohn Disease, run by Intuitive Surgical.
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 3 inclusion and 4 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Chart review on PeriOperative Information (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 26 Oct 2017.