NCT01453556

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 21, 2011

Status Verified

October 1, 2011

Enrollment Period

1.9 years

First QC Date

October 13, 2011

Last Update Submit

October 20, 2011

Conditions

Neoplastic or Benign Disease of Right ColonElective Laparoscopic Surgery

Keywords

Laparoscopic surgeryRight colectomyMechanical anastomosisPost-operative ileum

Outcome Measures

Primary Outcomes (1)

  • Post-operative canalisation time and length of stay

    Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups

    Post-operative stay (about 7 days)

Secondary Outcomes (1)

  • Impact of post-operative ileum and complications. Valuation of global costs

    12 months

Study Arms (2)

Intracorpopreal anastomosis

EXPERIMENTAL

Intracorporeal mechanical anastomosis

Procedure: Laparoscopic right colectomy

Extracorporeal anastomosis

ACTIVE COMPARATOR

Extracorporeal mechanical anastomosis

Procedure: Laparoscopic right colectomy

Interventions

Laparoscopic right colectomyPROCEDURE

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

Extracorporeal anastomosisIntracorpopreal anastomosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Scientific Institute

Milan, MI, 20132, Italy

RECRUITING

Study Officials

  • Andrea Vignali, MD

    San Raffaele Scientific Institute

    PRINCIPAL INVESTIGATOR

  • Carlo Staudacher, Prof

    San Raffaele Scientific Institute

    STUDY DIRECTOR

Central Study Contacts

Andrea Vignali, MD

CONTACT

0339 02 2643 2272maxbisso@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 18, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

October 21, 2011

Record last verified: 2011-10

Locations

IT(1)