INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer

NCT01679756 | Unknown DMC

• 1 other identifier: EAES 7625
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Laparoscopic right hemicolectomy; Intracorporeal anastomosis

Outcome Measures

Primary Outcomes (1)

• 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.

  60 days from surgery

Secondary Outcomes (14)

• Operative time

  day of intervention

• Largest incision length

  day of intervention

• Numbers of node harvested

  day of intervention

• Intraoperative complicatons

  day of intervention

• Mortality

  60 days from surgery

Study Arms (2)

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.

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.

Procedure: Laparoscopic right hemicolectomy for cancer

Interventions

Laparoscopic right hemicolectomy for cancer PROCEDURE

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.

Extracorporeal anastomosis; Intracorporeal anastomosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Informed consent refusal
• Metastatic disease
• Not right colon cancer
• Non elective procedure
• Open or converted operations

Sponsors & Collaborators

• Ospedale Misericordia e Dolce: lead

Study Sites (1)

Misericordia e Dolce Hospital

Prato, Po, 59100, Italy

Location

Related Publications (1)

• 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.

  PMID: 20703468 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Marco Scatizzi, MD

  Misericordia e Dolce Hospital

  STUDY CHAIR

• Francesco Feroci, MD

  Misericordia e Dolce Hospital

  STUDY DIRECTOR

• Stefano Cantafio, MD

  Misericordia e Dolce Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Feroci, MD

CONTACT

+393398382381

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 1, 2012
• First Posted: September 6, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

IT (1)