Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

NCT ID: NCT01453556

Last Updated: 2011-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-09-30

Brief Summary

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Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.

Detailed Description

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Conditions

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Neoplastic or Benign Disease of Right Colon Elective Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intracorpopreal anastomosis

Intracorporeal mechanical anastomosis

Group Type EXPERIMENTAL

Laparoscopic right colectomy

Intervention Type PROCEDURE

Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L

Extracorporeal anastomosis

Extracorporeal mechanical anastomosis

Group Type ACTIVE_COMPARATOR

Laparoscopic right colectomy

Intervention Type PROCEDURE

Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L

Interventions

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Laparoscopic right colectomy

Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 or more
* Benign o neoplastic disease of right colon
* Elective laparoscopic surgery

Exclusion Criteria

* Emergency surgery
* Adhesion or infiltration of near organs
* Severe heart disease ( New York Heart Association class \> 3 )
* Severe respiratory disease ( arterial PO2 \< 70 torr )
* Severe Liver disease (Child-Pugh class C)
* Ongoing infections
* Number of plasmatic neutrophil \< a 2.0 x 10 9/L
* Other contraindications to laparoscopy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Andrea Vignali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Vignali, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Scientific Institute

Carlo Staudacher, Prof

Role: STUDY_DIRECTOR

San Raffaele Scientific Institute

Locations

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San Raffaele Scientific Institute

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Vignali, MD

Role: CONTACT

0339 02 2643 2272

Facility Contacts

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Role: primary

0039 02 2643 2272

Other Identifiers

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Intraextra01

Identifier Type: -

Identifier Source: org_study_id