Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.

May 1, 2017 updated by: Prof. Mario Morino, University of Turin, Italy

Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.

During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However, the level of evidence coming from the currently available literature is low, based on the results of a few small and heterogeneous retrospective non-randomized studies. A randomised controlled trial is warranted to challenge these two procedures. The aim of this randomized controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right colectomy for right colon tumors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

While there are no differences in oncologic principles (no touch technique, proximal vessel ligation, lymphadenectomy) between laparoscopic right colectomy with IIA and EIA, potential advantages of IIA are: (1) no need for extensive mobilization of the transverse colon to reach the abdominal wall; (2) performing the anastomosis away from the abdominal wall may lead to reduced rates of superficial site infection; (3) a shorter incision for the specimen extraction may be associated with clinical benefits such as less pain and lower rates of superficial site infections; (4) laparoscopic visualization during the creation of the IIA may reduce unrecognized twisting of the terminal ileum mesentery, and (5) the ability to remove the specimen through any type of incision, with subsequent reduced risks of incisional hernias in case of Pfannenstiel incision when compared to midline or off-midline incisions.

Some retrospective and heterogeneous studies comparing perioperative outcomes after laparoscopic right colectomy with EIA and IIA have been published in the last decade, reporting controversial results. Furthermore, the results of recent metanalyses are challenged by the heterogeneity and the poor quality of the published studies. Lastly, no comprehensive economic evaluation of the two procedures have been performed yet.

Consecutive patients with right colon tumors are included in a randomized controlled trial. This is a single Institution prospective randomized controlled trial comparing the outcomes in patients undergoing laparoscopic right colectomy with IIA or EIA for right colon neoplasm. Eligible patients will be randomly assigned in a 1:1 ratio to undergo either laparoscopic IA or EA according to a list of randomization numbers with treatment assignments. This list will be computer generated. An Internet application will allow central randomization.

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs include healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marco E Allaix, MD, PhD
  • Phone Number: +390116335670
  • Email: mallaix@unito.it

Study Locations

  • Italy
      • Torino, Italy, 10126
        • Recruiting
        • Department of Surgical Sciences, University of Torino, AOU Città della Salute e della Scienza
        • Contact:
        • Principal Investigator:
          • Mario Morino, MD
        • Sub-Investigator:
          • Marco E Allaix, MD, PhD
        • Sub-Investigator:
          • Giuseppe Giraudo, MD, PhD
        • Sub-Investigator:
          • Alberto Arezzo, MD
        • Sub-Investigator:
          • Simone Arolfo, MD
        • Sub-Investigator:
          • Maurizio Degiuli, MD
        • Sub-Investigator:
          • Massimiliano Mistrangelo, MD, PhD
        • Sub-Investigator:
          • Roberto Passera, MD
        • Sub-Investigator:
          • Marco A Bonino, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient diagnosed with a solitary benign or malignant neoplasm localized in the right colon
  • Patients aged 18 years or older
  • Patients who give written informed consent

Exclusion Criteria:

  • acute intestinal obstruction
  • colon perforation;
  • liver and/or lung metastases;
  • multiple primary colonic tumors;
  • scheduled need for synchronous intra-abdominal surgery;
  • preoperative evidence of invasion of adjacent structures, as assessed by CT or ultrasonography;
  • previous ipsilateral colon surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intracorporeal ileocolic anastomosis (IIA)
After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected and a side-to-side anastomosis is fashioned with a laparoscopic stapler.
Procedure: Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)
After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The antimesenteric side of the stapled ends of the transverse colon and terminal ileum are approximated by a stay suture tied intracorporeally and then held by the assistant. An antimesenteric enterotomy and an antimesenteric colotomy are made about 10 cm distal to the stapled ends of the transverse colon and terminal ileum, respectively. A side-to-side anastomosis is fashioned with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The enterotomies are then closed by two layers of reabsorbable sutures tied intracorporeally. The specimen is delivered through a small Pfannenstiel or a median incision. A big dressing covering all incisions will be applied, similar to that used for the EIA group.
Active Comparator: Extracorporeal ileocolic anastomosis
After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. Then, a primary ileocolic side-to-side handsewn or mechanical anastomosis is fashioned extracorporeally.
Procedure: Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)
After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. A primary ileocolic side-to-side handsewn or mechanical (with GIA stapler - Covidien Medtronic) anastomosis is fashioned and the bowel returned to the abdominal cavity. After reinduction of pneumoperitoneum, the lack of twists of the ileocolic anastomosis is checked. A big dressing covering all incisions will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of incisions
Time Frame: At the end of the operation
At the end of the operation
Intraoperative complications
Time Frame: intraoperatively
intraoperatively
Number of lymph nodes harvested
Time Frame: 3 weeks
evaluation of the number of lymph nodes in the specimen on pathology report
3 weeks
30-day postoperative morbidity according to the Clavien-Dindo classification
Time Frame: 1 month
1 month
First gas and stool passage
Time Frame: 1 week
1 week
Evaluation of postoperative pain (VAS)
Time Frame: 1 week
measurement of VAS scores
1 week
Duration of intravenous analgesic therapy
Time Frame: 1 week
1 week
Narcotics use rate
Time Frame: from day 1 to day 5 after surgery
percentage of patients requiring narcotics after surgery
from day 1 to day 5 after surgery
Reoperation rate
Time Frame: 1 week
1 week
Hospital readmission
Time Frame: 90 days
rate and causes of hospital readmission
90 days
In-hospital costs
Time Frame: 60 days
Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs included healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.
60 days
Rate of incisional hernias
Time Frame: postoperatively at 3 and 6 months
postoperatively at 3 and 6 months
Quality of life
Time Frame: preoperatively, at 3 and 6 months after surgery
the SF-12 questionnaire will assess quality of life
preoperatively, at 3 and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Mario Morino, MD, University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Anticipated)

January 31, 2020

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 3, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS 863

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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