Neoplastic or Benign Disease of Right ColonNCT01453556
Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy
A study testing Laparoscopic right colectomy in people with Neoplastic or Benign Disease of Right Colon and Elective Laparoscopic Surgery, run by Scientific Institute San Raffaele at 1 site in Italy.
Trial summary
Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplastic or Benign Disease of Right Colon, Elective Laparoscopic Surgery
- What is being tested?
- Laparoscopic right colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Sep 2014
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 or more
- Benign o neoplastic disease of right colon
- Elective laparoscopic surgery
Who cannot join
- Emergency surgery
- Adhesion or infiltration of near organs
- Severe heart disease ( New York Heart Association class > 3 )
- Severe respiratory disease ( arterial PO2 < 70 torr )
- Severe Liver disease (Child-Pugh class C)
- Ongoing infections
- Number of plasmatic neutrophil < a 2.0 x 10 9/L
- Other contraindications to laparoscopy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Scientific Institute
Milan, MI, 20132
0039 02 2643 2272, maxbisso@gmail.com
Andrea Vignali, MD
About this study
Official title: Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial
Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.
- Being tested
- Laparoscopic right colectomy
- Keywords
- Laparoscopic surgery, Right colectomy, Mechanical anastomosis, Post-operative ileum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic right colectomyProcedure or surgery
Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L
| Study group | Role | What they receive |
|---|---|---|
| Intracorpopreal anastomosis | Experimental | Intracorporeal mechanical anastomosis Receives: Procedure: Laparoscopic right colectomy |
| Extracorporeal anastomosis | Active comparator | Extracorporeal mechanical anastomosis Receives: Procedure: Laparoscopic right colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative canalisation time and length of stay
Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups
Measured: Post-operative stay (about 7 days)
Secondary outcomes (1)
Impact of post-operative ileum and complications. Valuation of global costs
Comparison of post-operative short and long-term complications (in particular post-operative ileum) between the two study groups. Valuation of global costs differences.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic or Benign Disease of Right ColonStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Vignali, Scientific Institute San Raffaele
- Investigators
- Andrea Vignali, MD, Principal investigator, San Raffaele Scientific InstituteCarlo Staudacher, Prof, Study director, San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453556
- Sponsor's protocol ID
- Intraextra01
- Status last verified
- Oct 2011
- First submitted
- 13 Oct 2011
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01453556
- Acronym / sponsor ID
- Intraextra01
- Keywords
- Laparoscopic surgery, Right colectomy, Mechanical anastomosis, Post-operative ileum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 18 Oct 2011 (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.
Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorpopreal anastomosis | Experimental | Procedure: Laparoscopic right colectomyIntracorporeal mechanical anastomosis |
| Extracorporeal anastomosis | Active comparator | Procedure: Laparoscopic right colectomyExtracorporeal mechanical anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or more
- Benign o neoplastic disease of right colon
- Elective laparoscopic surgery
Key exclusion criteria (8 listed)
- Emergency surgery
- Adhesion or infiltration of near organs
- Severe heart disease ( New York Heart Association class > 3 )
- Severe respiratory disease ( arterial PO2 < 70 torr )
- Severe Liver disease (Child-Pugh class C)
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 |
|---|---|---|
| Laparoscopic right colectomyLaparoscopic right colectomy with mechanical ileo-colon anastomosis L-L | Procedure or surgery | Extracorporeal anastomosis, Intracorpopreal anastomosis |
Primary outcome
Post-operative canalisation time and length of stay
Time frame: Post-operative stay (about 7 days)
Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups
1 secondary outcome
Impact of post-operative ileum and complications. Valuation of global costs
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
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.
Andrea Vignali, MD principal investigator
San Raffaele Scientific Institute
Carlo Staudacher, Prof study director
San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic right colectomy in people with Neoplastic or Benign Disease of Right Colon and Elective Laparoscopic Surgery, run by Scientific Institute San Raffaele at 1 site in Italy.
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 8 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: status not confirmed, as of the sponsor's last update on 21 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Vignali, MD (0339 02 2643 2272, maxbisso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative canalisation time and length of stay (time frame: Post-operative stay (about 7 days)). 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 21 Oct 2011.