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INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer (INEXTREMO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Marco Scatizzi, Ospedale Misericordia e Dolce.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679756
First Posted: September 6, 2012
Last Update Posted: September 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marco Scatizzi, Ospedale Misericordia e Dolce
  Purpose
The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer.

Condition Intervention
Colorectal Cancer Procedure: Laparoscopic right hemicolectomy for cancer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer: a Randomized Clinical Trial. (IN EXTREMO Study)

Further study details as provided by Marco Scatizzi, Ospedale Misericordia e Dolce:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Operative time [ Time Frame: day of intervention ]
    Minutes from skin incision to skin closure

  • Largest incision length [ Time Frame: day of intervention ]
    millimeters of skin incision

  • Numbers of node harvested [ Time Frame: day of intervention ]
    Numbers of node harvested

  • Intraoperative complicatons [ Time Frame: day of intervention ]
    Incidence and kind of intraoperative morbidity

  • Mortality [ Time Frame: 60 days from surgery ]
    Incidence and kind of intraoperative morbidity

  • Non surgical site complications [ Time Frame: 60 days from surgery ]
    Incidence and kind of medical morbidity (cardiovascular, respiratory, or metabolic events; nonsurgical infections; deep venous thrombosis; and pulmonary embolism)

  • Bowel movement [ Time Frame: 10 days from surgery ]
    Defined as hours from surgery to peristalsis, assessement every 8 hours

  • First flatus [ Time Frame: 10 days from surgery ]
    Defined as hours from surgery to first flatus

  • First stool canalization [ Time Frame: 10 days from surgery ]
    Defined as hours from surgery to first stool canalization

  • Time to solid diet [ Time Frame: 10 days from surgery ]
    Defined as hours from surgery to solid diet tolerance

  • Naso gastric tube reintroduction [ Time Frame: 60 days from surgery ]
    Defined as rate of NGT reintroduction

  • Days of analgesic usage [ Time Frame: 60 days from surgery ]
    Defined as number of days after interventions

  • Length of hospital stay [ Time Frame: 60 days from surgery ]
    Defined as day from surgery to dismission plus eventual days of recovery after readmission

  • Readmission [ Time Frame: 60 day from intervention ]
    Rate of readmission after home dimission


Estimated Enrollment: 384
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intracorporeal anastomosis
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.
Procedure: Laparoscopic right hemicolectomy for cancer
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.
Active Comparator: Extracorporeal anastomosis

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.

Procedure: Laparoscopic right hemicolectomy for cancer
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Informed consent refusal
  • Metastatic disease
  • Not right colon cancer
  • Non elective procedure
  • Open or converted operations
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679756


Contacts
Contact: Francesco Feroci, MD +393398382381

Locations
Italy
Misericordia e Dolce Hospital Not yet recruiting
Prato, Po, Italy, 59100
Contact: Francesco Feroci, MD    +393398382381    fferoci@yahoo.it   
Principal Investigator: Elisa Lenzi, MD         
Sub-Investigator: Andrea Vannucchi, MD         
Sub-Investigator: Alessia Garzi, MD         
Sub-Investigator: Maddalena Baraghini, MD         
Sponsors and Collaborators
Ospedale Misericordia e Dolce
Investigators
Study Chair: Marco Scatizzi, MD Misericordia e Dolce Hospital
Study Director: Francesco Feroci, MD Misericordia e Dolce Hospital
Principal Investigator: Stefano Cantafio, MD Misericordia e Dolce Hospital
  More Information

Publications:
Responsible Party: Marco Scatizzi, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT01679756     History of Changes
Other Study ID Numbers: EAES 7625
First Submitted: September 1, 2012
First Posted: September 6, 2012
Last Update Posted: September 6, 2012
Last Verified: September 2012

Keywords provided by Marco Scatizzi, Ospedale Misericordia e Dolce:
Colorectal cancer
Laparoscopic right hemicolectomy
Intracorporeal anastomosis

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases