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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Ospedale Misericordia e Dolce
Sponsor:
Information provided by (Responsible Party):
Marco Scatizzi, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT01679756
First received: September 1, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer: a Randomized Clinical Trial. (IN EXTREMO Study)

Resource links provided by NLM:


Further study details as provided by Ospedale Misericordia e Dolce:

Primary Outcome Measures:
  • Overall surgical morbidity [ Time Frame: 60 days from surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Minutes from skin incision to skin closure

  • Largest incision length [ Time Frame: day of intervention ] [ Designated as safety issue: No ]
    millimeters of skin incision

  • Numbers of node harvested [ Time Frame: day of intervention ] [ Designated as safety issue: No ]
    Numbers of node harvested

  • Intraoperative complicatons [ Time Frame: day of intervention ] [ Designated as safety issue: Yes ]
    Incidence and kind of intraoperative morbidity

  • Mortality [ Time Frame: 60 days from surgery ] [ Designated as safety issue: Yes ]
    Incidence and kind of intraoperative morbidity

  • Non surgical site complications [ Time Frame: 60 days from surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Defined as hours from surgery to peristalsis, assessement every 8 hours

  • First flatus [ Time Frame: 10 days from surgery ] [ Designated as safety issue: No ]
    Defined as hours from surgery to first flatus

  • First stool canalization [ Time Frame: 10 days from surgery ] [ Designated as safety issue: No ]
    Defined as hours from surgery to first stool canalization

  • Time to solid diet [ Time Frame: 10 days from surgery ] [ Designated as safety issue: No ]
    Defined as hours from surgery to solid diet tolerance

  • Naso gastric tube reintroduction [ Time Frame: 60 days from surgery ] [ Designated as safety issue: No ]
    Defined as rate of NGT reintroduction

  • Days of analgesic usage [ Time Frame: 60 days from surgery ] [ Designated as safety issue: No ]
    Defined as number of days after interventions

  • Length of hospital stay [ Time Frame: 60 days from surgery ] [ Designated as safety issue: No ]
    Defined as day from surgery to dismission plus eventual days of recovery after readmission

  • Readmission [ Time Frame: 60 day from intervention ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 1, 2012
Last Updated: September 1, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014