Benign Right Colon DiseaseANCORNCT03312569
Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses
An observational study of Benign Right Colon Disease and Malignant Right Colon Disease, run by Intuitive Surgical at 4 sites in United States.
Trial summary
To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Right Colon Disease, Malignant Right Colon Disease
- What is being tested?
- Right Colectomy with Intracorporeal Anastomosis and Right Colectomy with Extracorporeal Anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 306 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2018to 24 Jul 2023
- 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: Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
Who may be able to join
- Subject is 18 years or older
- Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
- Subject undergoing intracorporeal or extracorporeal anastomosis proximal to mid-transverse colon
Who cannot join
- Subject is contraindicated for general anesthesia or surgery
- Emergent Case
- Subject has perforated, obstructing or locally invasive neoplasm (T4b)
- Subject with inflammatory bowel disease
- Subject with prior incisional hernia repair
- Planned right colectomy along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
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- Metastatic disease with life expectancy of less than 1 year
- Pregnant or suspect pregnancy
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48197
University of California
Irvine, California, 92697
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Washington University at St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies
Read the detailed description
This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.
- Being tested
- Right Colectomy with Intracorporeal Anastomosis, Right Colectomy with Extracorporeal Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Colectomy with Intracorporeal AnastomosisProcedure or surgery
With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. The right mesocolon is mobilized and the ileal mesentery is divided. The transverse colon and ileum are then divided with the stapler. Next, attention is turned to constructing the anastomosis. For this purpose, the terminal ileum and the transverse colon stump are brought together. A colotomy and ileostomy is created to form a common channel. The common enterotomy is then closed as per the surgeon's standard of care. The specimen is extracted through an off-midline incision (muscle splitting transverse incision, Pfannenstiel).
Right Colectomy with Extracorporeal AnastomosisProcedure or surgery
With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. Intracorporeal devascularization may be performed at the surgeon's discretion. The gastrocolic ligament is taken down and the hepatic flexure is mobilized. After complete mobilization of the right colon, the midline incision is extended to serve as the extraction site. The specimen is delivered through the midline extraction incision and the anastomosis is conducted in a standard open technique. The two cut ends of the bowels are aligned for extracorporeal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal Anastomosis | Participants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease. Receives: Procedure: Right Colectomy with Intracorporeal Anastomosis | |
| Extracorporeal Anastomosis | Participants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease. Receives: Procedure: Right Colectomy with Extracorporeal Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia at one year after index procedure.
The primary endpoint of the study is the incidence of incisional hernia for intracorporeal and extracorporeal anastomoses within one year after the right colectomy procedure. Incidence of incisional hernia either patient self-reported or clinical diagnosis will be assessed at one year after the right colectomy procedure.
Measured: 1 year
Secondary outcomes (1)
Time to first flatus after index procedure
The secondary endpoint of the study is time to first flatus for intracorporeal and extracorporeal anastomoses after the right colectomy procedure. Time to first flatus is defined as days from a right colectomy procedure to first occurrence of flatus during subject's post-operative recovery.
Measured: up to 1 week after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Feb 2018
- Primary completion14 Feb 2022
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Right Colon DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shilpa Mehendale, Study director, Intuitive Surgical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312569
- Sponsor's protocol ID
- ISI-dVRC-002
- Acronym
- ANCOR
- Status last verified
- Mar 2024
- First submitted
- 12 Oct 2017
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cleary RK, Silviera M, Reidy TJ, McCormick J, Johnson CS, Sylla P, Cannon J, Lujan H, Kassir A, Landmann RG, Gaertner W, Lee E, Bastawrous AL, Bardakcioglu O, Pandey S, Attaluri V, Bernstein M, Obias V, Pigazzi A. Extraction site hernia and short-term outcomes following intracorporeal versus extracorporeal anastomosis for robotic and laparoscopic right colectomy: a multi-center prospective trial. Surg Endosc. 2026 Jan;40(1):502-511. doi: 10.1007/s00464-025-12327-7. Epub 2025 Oct 27.
PubMed 41145697
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
- ClinicalTrials.gov ID
- NCT03312569
- Acronym / sponsor ID
- ANCOR / ISI-dVRC-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 17 Oct 2017 (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.
To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies
Detailed description
This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal Anastomosis | – | Procedure: Right Colectomy with Intracorporeal AnastomosisParticipants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease. |
| Extracorporeal Anastomosis | – | Procedure: Right Colectomy with Extracorporeal AnastomosisParticipants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
Key inclusion criteria (3 listed)
- Subject is 18 years or older
- Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
- Subject undergoing intracorporeal or extracorporeal anastomosis proximal to mid-transverse colon
Key exclusion criteria (10 listed)
- Subject is contraindicated for general anesthesia or surgery
- Emergent Case
- Subject has perforated, obstructing or locally invasive neoplasm (T4b)
- Subject with inflammatory bowel disease
- Subject with prior incisional hernia repair
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 Colectomy with Intracorporeal AnastomosisWith the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. The right mesocolon is mobilized and the ileal mesentery is divided. The transverse colon and ileum are then divided with the stapler. Next, attention is turned to constructing the anastomosis. For this purpose, the terminal ileum and the transverse colon stump are brought together. A colotomy and ileostomy is created to form a common channel. The common enterotomy is then closed as per the surgeon's standard of care. The specimen is extracted through an off-midline incision (muscle splitting transverse incision, Pfannenstiel). | Procedure or surgery | Intracorporeal Anastomosis |
| Right Colectomy with Extracorporeal AnastomosisWith the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. Intracorporeal devascularization may be performed at the surgeon's discretion. The gastrocolic ligament is taken down and the hepatic flexure is mobilized. After complete mobilization of the right colon, the midline incision is extended to serve as the extraction site. The specimen is delivered through the midline extraction incision and the anastomosis is conducted in a standard open technique. The two cut ends of the bowels are aligned for extracorporeal anastomosis. | Procedure or surgery | Extracorporeal Anastomosis |
Primary outcome
Incidence of incisional hernia at one year after index procedure.
Time frame: 1 year
The primary endpoint of the study is the incidence of incisional hernia for intracorporeal and extracorporeal anastomoses within one year after the right colectomy procedure. Incidence of incisional hernia either patient self-reported or clinical diagnosis will be assessed at one year after the right colectomy procedure.
1 secondary outcome
Time to first flatus after index procedure
Time frame: up to 1 week after index procedure
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 12 Mar 2024.
- Derived from this study: PubMed 41145697Cleary RK, Silviera M, Reidy TJ, McCormick J, Johnson CS, Sylla P, Cannon J, Lujan H, Kassir A, Landmann RG, Gaertner W, Lee E, Bastawrous AL, Bardakcioglu O, Pandey S, Attaluri V, Bernstein M, Obias V, Pigazzi A. Extraction site hernia and short-term outcomes following intracorporeal versus extracorporeal anastomosis for robotic and laparoscopic right colectomy: a multi-center prospective trial. Surg Endosc. 2026 Jan;40(1):502-511. doi: 10.1007/s00464-025-12327-7. Epub 2025 Oct 27.
- Individual participant dataSharing planned: No
Related trials for Benign Right Colon Disease
Not yet recruiting
Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy
Colorectal Neoplasms, Colorectal Neoplasms Malignant
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
Intuitive Surgical
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Right Colon Disease and Malignant Right Colon Disease, run by Intuitive Surgical at 4 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 3 inclusion and 10 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Incidence of incisional hernia at one year after index procedure. (time frame: 1 year). 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 NCT03312569, which also lists 1 linked publication.
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 12 Mar 2024.