Colorectal CancerINEXTREMONCT01679756
INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer
A study testing Laparoscopic right hemicolectomy for cancer in people with Colorectal Cancer, run by Ospedale Misericordia e Dolce at 1 site in Italy.
Trial summary
The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Laparoscopic right hemicolectomy for cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suitable for curative surgery 18-80 years old
- ASA grade I-III
- Histhopatological confirmed right only colon carcinoma.
- Elective interventions
- Laparoscopic surgery
- Informed consent
Who cannot join
- Informed consent refusal
- Metastatic disease
- Not right colon cancer
- Non elective procedure
- Open or converted operations
Trial locations and contacts
1 site in 1 country.
Francesco Feroci, MD contact
Italy1 site
Misericordia e Dolce Hospital
Prato, Po, 59100
Francesco Feroci, MD, +393398382381, fferoci@yahoo.it
Elisa Lenzi, MD
About this study
Official title: INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer: a Randomized Clinical Trial. (IN EXTREMO Study)
The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer.
Read the detailed description
Background. Only a few retrospective publications comparing these anastomotic techniques and no randomized clinical trial has been performed. We conducted a meta-analysis of the existing non randomized comparative studies on the argument: the results suggest that the IA results in better postoperative recovery outcomes, such as shorter hospital stay, faster bowel movement recovery, faster first flatus, faster time to solid diet and lesser analgesic usage.
Design: Two-armed, double-blinded, randomized, controlled study.
The patients will be randomized into two groups:
- After laparoscopic right colectomy for cancer, anastomosis will be carried out intracorporeally (IA) B. After laparoscopic right colectomy for cancer, anastomosis will be carried out extracorporeally (EA)
Primary endpoint: Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.
Secondary endpoints:
- Intra-operative: operative time, largest incision length (mm), number of nodes harvested, intraoperative complications.
- Early postoperative: mortality, non-surgical site complications.
- Postoperative recovery: bowel movement, first flatus, time to solid diet, nasogastric tube (NGT) reintroduction, day of analgesic usage, length of stay, readmission.
Randomization. The randomization will be obtained through a computer generated program (GraphPad Software, Inc, La Jolla, California, USA). The randomization, will be done before the beginning of the study and it will consist with an ordered series of numbers with a corresponding letter: A for intracorporeal anastomosis and B for extracorporeal anastomosis. This series of numbers will be kept in a central dedicated web database; after right colon cancer diagnosis, if the patient fulfills the inclusion criteria and signs the consent a number, progressive as in order of inclusion, will be assigned to him or her. The letter corresponding to the number, and hence the type of procedure to perform, will be notified to the operating surgeon, who will proceed accordingly.
Blinding. A second surgeon team (different from the one who participate in the intervention), aware of the operative findings but not the management of the anastomosis, will then assume the care of the patient. Postoperative care and ability to be discharged from the hospital will be determined by the second surgical team. This second surgical team will be blinded to the kind of anastomosis. The primary operative team will be in every moment available for emergent consultation.
Power Calculation. The reported prevalence of surgical morbidity after laparoscopic colectomy varies widely from 5-15%16-39, usually depending on the definition of complications and the type of resection performed. The most recent Cochrane review on the argument indicates a 8.6% of local morbidity (Wound infection, anastomotic insufficiency, postoperative ileus, postoperative bleeding)40. Therefore the number of patients required was based on the hope of improving the rate of surgical morbidity from 8.6% to 4.3%; considering a drop-out rate of 5%, 384 patients (192 in the IA group and 192 in the EA group) are necessary to ensure an 80% power with an alpha of 5%, when using a two-sided log-rank test. The statistical power sample calculation was carried out using PASS 2005 (Power Analysis and Sample Size, within the statistical package "NCSS 2004 and PASS 2005").
Sixty-four patients will be included by each of the six centers of the consortium. Only surgeons with at least 30 right colectomies performed with intracorporeal anastomosis will be allowed to recruit patients as first operator.
Statistics. To evaluate significance of differences between the two groups, chi-squared and Fisher's exact test will be used as appropriated for categorical variables, and the non-parametric Mann-Whitney U-test for continuous variables. Significance level will be set at 5%. The statistical analysis will be carried out using the Statistical Package for the Social Sciences (SPSS version 13; SPSS Inc. Chicago, Illinois, USA).
Monitoring. as commonly requested for Randomized Controlled Trials on patients, a strict control of outcomes has been planned during the study. Three experts in laparoscopic colorectal surgery will be designed as member of IN EXTREMO Trial Monitoring Committee. They would have access to the data during the whole course of the study and indicate cessation of the trial if one arm is providing manifestly inferior results.
- Conditions
- Colorectal Cancer
- Being tested
- Laparoscopic right hemicolectomy for cancer
- Keywords
- Colorectal cancer, Laparoscopic right hemicolectomy, Intracorporeal anastomosis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic right hemicolectomy for cancerProcedure or surgery
After induction of anesthesia, a foley catheter and an NG tube will be inserted. All patients will have their NG tubes removed after the procedure. During the procedure patients will be placed in Trendelenburg position with 15 degrees of tilt and with a right side up (tilt to the left of 25 degrees). A Veres needle will be inserted and pneumoperitoneum induced and maintained at 12 mmHg for the entire duration of the procedure. Under direct vision, three 10-12mm trocars will be inserted in the left abdominal wall. The ileocolic vessels, the right colic vessels (when present), the right branch of the middle colic vessels and the right gastroepiploic vessels will be ligated intracorporeally at their origin using clips. Anastomosis are described in each arm description.
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomosis | Experimental | Laparoscopic right hemicolectomy for cancer. .For the IA group, colon, transverse mesocolon, ileum and terminal ileum mesentery will be resected intracorporeally through a 45 mm endoscopic linear stapler with vascular cartridge. Then, the linear stapler will inserted through two small enterotomies and a mechanical ileo-transverse, side-to-side isoperistaltic intracorporeal anastomosis performed using the vascular cartridge with six rows of closely placed staples. The enterotomies will be then closed using a double layered continuous intra corporeal manual suture with 3-0 Polyglactin 910. The mesenteric defects will be left open. The specimen will be placed in a protective plastic bag and then extracted through a Pfannestiel incision. Receives: Procedure: Laparoscopic right hemicolectomy for cancer |
| Extracorporeal anastomosis | Active comparator | Laparoscopic right hemicolectomy for cancer. In the EA group, the bowel will be externalized by widening the incision of one of the trocars or by performing a mini-laparotomy at another location (subcostal, suprapubic) protected with a plastic sheet. The ileum and colon will be then resected through a 45 mm endoscopic linear stapler with vascular cartridge (staple height = 3.85 mm) and a side-to-side isoperistaltic mechanical anastomosis will be then performed using the same vascular cartridge. The enterotomies will be then closed using a double layered continuous manual suture using a 3-0 Polyglactin 910.
In both groups, a drain will not routinely inserted. Receives: Procedure: Laparoscopic right hemicolectomy for cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall surgical morbidity
Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.
Measured: 60 days from surgery
Secondary outcomes (14)
Operative time
Minutes from skin incision to skin closure
Measured: day of intervention
Largest incision length
millimeters of skin incision
Measured: day of intervention
Numbers of node harvested
Numbers of node harvested
Measured: day of intervention
Intraoperative complicatons
Incidence and kind of intraoperative morbidity
Measured: day of intervention
Mortality
Incidence and kind of intraoperative morbidity
Measured: 60 days from surgery
Non surgical site complications
Incidence and kind of medical morbidity (cardiovascular, respiratory, or metabolic events; nonsurgical infections; deep venous thrombosis; and pulmonary embolism)
Measured: 60 days from surgery
Bowel movement
Defined as hours from surgery to peristalsis, assessement every 8 hours
Measured: 10 days from surgery
First flatus
Defined as hours from surgery to first flatus
Measured: 10 days from surgery
First stool canalization
Defined as hours from surgery to first stool canalization
Measured: 10 days from surgery
Time to solid diet
Defined as hours from surgery to solid diet tolerance
Measured: 10 days from surgery
Naso gastric tube reintroduction
Defined as rate of NGT reintroduction
Measured: 60 days from surgery
Days of analgesic usage
Defined as number of days after interventions
Measured: 60 days from surgery
Length of hospital stay
Defined as day from surgery to dismission plus eventual days of recovery after readmission
Measured: 60 days from surgery
Readmission
Rate of readmission after home dimission
Measured: 60 day from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionJun 2014 (estimated)
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 Colorectal CancerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Misericordia e Dolce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Scatizzi, Ospedale Misericordia e Dolce
- Investigators
- Marco Scatizzi, MD, Study chair, Misericordia e Dolce HospitalFrancesco Feroci, MD, Study director, Misericordia e Dolce HospitalStefano Cantafio, MD, Principal investigator, Misericordia e Dolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679756
- Sponsor's protocol ID
- EAES 7625
- Acronym
- INEXTREMO
- Status last verified
- Sep 2012
- First submitted
- 1 Sep 2012
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scatizzi M, Kroning KC, Borrelli A, Andan G, Lenzi E, Feroci F. Extracorporeal versus intracorporeal anastomosis after laparoscopic right colectomy for cancer: a case-control study. World J Surg. 2010 Dec;34(12):2902-8. doi: 10.1007/s00268-010-0743-6.
PubMed 20703468
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer: a Randomized Clinical Trial. (IN EXTREMO Study)
- ClinicalTrials.gov ID
- NCT01679756
- Acronym / sponsor ID
- INEXTREMO / EAES 7625
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Laparoscopic right hemicolectomy, Intracorporeal anastomosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Ospedale Misericordia e DolceUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 6 Sep 2012 (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 aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer.
Detailed description
Background. Only a few retrospective publications comparing these anastomotic techniques and no randomized clinical trial has been performed. We conducted a meta-analysis of the existing non randomized comparative studies on the argument: the results suggest that the IA results in better postoperative recovery outcomes, such as shorter hospital stay, faster bowel movement recovery, faster first flatus, faster time to solid diet and lesser analgesic usage.
Design: Two-armed, double-blinded, randomized, controlled study.
The patients will be randomized into two groups:
- After laparoscopic right colectomy for cancer, anastomosis will be carried out intracorporeally (IA) B. After laparoscopic right colectomy for cancer, anastomosis will be carried out extracorporeally (EA)
Primary endpoint: Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.
Secondary endpoints:
- Intra-operative: operative time, largest incision length (mm), number of nodes harvested, intraoperative complications.
- Early postoperative: mortality, non-surgical site complications.
- Postoperative recovery: bowel movement, first flatus, time to solid diet, nasogastric tube (NGT) reintroduction, day of analgesic usage, length of stay, readmission.
Randomization. The randomization will be obtained through a computer generated program (GraphPad Software, Inc, La Jolla, California, USA). The randomization, will be done before the beginning of the study and it will consist with an ordered series of numbers with a corresponding letter: A for intracorporeal anastomosis and B for extracorporeal anastomosis. This series of numbers will be kept in a central dedicated web database; after right colon cancer diagnosis, if the patient fulfills the inclusion criteria and signs the consent a number, progressive as in order of inclusion, will be assigned to him or her. The letter corresponding to the number, and hence the type of procedure to perform, will be notified to the operating surgeon, who will proceed accordingly.
Blinding. A second surgeon team (different from the one who participate in the intervention), aware of the operative findings but not the management of the anastomosis, will then assume the care of the patient. Postoperative care and ability to be discharged from the hospital will be determined by the second surgical team. This second surgical team will be blinded to the kind of anastomosis. The primary operative team will be in every moment available for emergent consultation.
Power Calculation. The reported prevalence of surgical morbidity after laparoscopic colectomy varies widely from 5-15%16-39, usually depending on the definition of complications and the type of resection performed. The most recent Cochrane review on the argument indicates a 8.6% of local morbidity (Wound infection, anastomotic insufficiency, postoperative ileus, postoperative bleeding)40. Therefore the number of patients required was based on the hope of improving the rate of surgical morbidity from 8.6% to 4.3%; considering a drop-out rate of 5%, 384 patients (192 in the IA group and 192 in the EA group) are necessary to ensure an 80% power with an alpha of 5%, when using a two-sided log-rank test. The statistical power sample calculation was carried out using PASS 2005 (Power Analysis and Sample Size, within the statistical package "NCSS 2004 and PASS 2005").
Sixty-four patients will be included by each of the six centers of the consortium. Only surgeons with at least 30 right colectomies performed with intracorporeal anastomosis will be allowed to recruit patients as first operator.
Statistics. To evaluate significance of differences between the two groups, chi-squared and Fisher's exact test will be used as appropriated for categorical variables, and the non-parametric Mann-Whitney U-test for continuous variables. Significance level will be set at 5%. The statistical analysis will be carried out using the Statistical Package for the Social Sciences (SPSS version 13; SPSS Inc. Chicago, Illinois, USA).
Monitoring. as commonly requested for Randomized Controlled Trials on patients, a strict control of outcomes has been planned during the study. Three experts in laparoscopic colorectal surgery will be designed as member of IN EXTREMO Trial Monitoring Committee. They would have access to the data during the whole course of the study and indicate cessation of the trial if one arm is providing manifestly inferior results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomosis | Experimental | Procedure: Laparoscopic right hemicolectomy for cancerLaparoscopic right hemicolectomy for cancer. .For the IA group, colon, transverse mesocolon, ileum and terminal ileum mesentery will be resected intracorporeally through a 45 mm endoscopic linear stapler with vascular cartridge. Then, the linear stapler will inserted through two small enterotomies and a mechanical ileo-transverse, side-to-side isoperistaltic intracorporeal anastomosis performed using the vascular cartridge with six rows of closely placed staples. The enterotomies will be then closed using a double layered continuous intra corporeal manual suture with 3-0 Polyglactin 910. The mesenteric defects will be left open. The specimen will be placed in a protective plastic bag and then extracted through a Pfannestiel incision. |
| Extracorporeal anastomosis | Active comparator | Procedure: Laparoscopic right hemicolectomy for cancerLaparoscopic right hemicolectomy for cancer. In the EA group, the bowel will be externalized by widening the incision of one of the trocars or by performing a mini-laparotomy at another location (subcostal, suprapubic) protected with a plastic sheet. The ileum and colon will be then resected through a 45 mm endoscopic linear stapler with vascular cartridge (staple height = 3.85 mm) and a side-to-side isoperistaltic mechanical anastomosis will be then performed using the same vascular cartridge. The enterotomies will be then closed using a double layered continuous manual suture using a 3-0 Polyglactin 910. In both groups, a drain will not routinely inserted. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients suitable for curative surgery 18-80 years old
- ASA grade I-III
- Histhopatological confirmed right only colon carcinoma.
- Elective interventions
- Laparoscopic surgery
Key exclusion criteria (5 listed)
- Informed consent refusal
- Metastatic disease
- Not right colon cancer
- Non elective procedure
- Open or converted operations
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 hemicolectomy for cancerAfter induction of anesthesia, a foley catheter and an NG tube will be inserted. All patients will have their NG tubes removed after the procedure. During the procedure patients will be placed in Trendelenburg position with 15 degrees of tilt and with a right side up (tilt to the left of 25 degrees). A Veres needle will be inserted and pneumoperitoneum induced and maintained at 12 mmHg for the entire duration of the procedure. Under direct vision, three 10-12mm trocars will be inserted in the left abdominal wall. The ileocolic vessels, the right colic vessels (when present), the right branch of the middle colic vessels and the right gastroepiploic vessels will be ligated intracorporeally at their origin using clips. Anastomosis are described in each arm description. | Procedure or surgery | Extracorporeal anastomosis, Intracorporeal anastomosis |
Primary outcome
Overall surgical morbidity
Time frame: 60 days from surgery
Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.
14 secondary outcomes
Operative time
Time frame: day of intervention
Largest incision length
Time frame: day of intervention
Numbers of node harvested
Time frame: day of intervention
Intraoperative complicatons
Time frame: day of intervention
Mortality
Time frame: 60 days from surgery
Non surgical site complications
Time frame: 60 days from surgery
Bowel movement
Time frame: 10 days from surgery
First flatus
Time frame: 10 days from surgery
First stool canalization
Time frame: 10 days from surgery
Time to solid diet
Time frame: 10 days from surgery
Naso gastric tube reintroduction
Time frame: 60 days from surgery
Days of analgesic usage
Time frame: 60 days from surgery
Length of hospital stay
Time frame: 60 days from surgery
Readmission
Time frame: 60 day from intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Background: PubMed 20703468Scatizzi M, Kroning KC, Borrelli A, Andan G, Lenzi E, Feroci F. Extracorporeal versus intracorporeal anastomosis after laparoscopic right colectomy for cancer: a case-control study. World J Surg. 2010 Dec;34(12):2902-8. doi: 10.1007/s00268-010-0743-6.
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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.
Francesco Feroci, MD contact
Marco Scatizzi, MD study chair
Misericordia e Dolce Hospital
Francesco Feroci, MD study director
Misericordia e Dolce Hospital
Stefano Cantafio, MD principal investigator
Misericordia e Dolce Hospital
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 hemicolectomy for cancer in people with Colorectal Cancer, run by Ospedale Misericordia e Dolce 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 6 inclusion and 5 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 6 Sep 2012. 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 Francesco Feroci, MD (+393398382381), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall surgical morbidity (time frame: 60 days from surgery). 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 NCT01679756, 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 6 Sep 2012.