NCT01772407

Brief Summary

The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2009

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 20, 2017

Status Verified

May 1, 2016

Enrollment Period

6.9 years

First QC Date

January 17, 2013

Last Update Submit

November 17, 2017

Conditions

Colon Cancer

Keywords

Colon Cancer SurgeryLaparoscopyOpen surgeryCostsMortalityMorbidityQuality of life

Outcome Measures

Primary Outcomes (1)

  • Cost during the 2 postoperative years

    during the 2 postoperative years

Secondary Outcomes (1)

  • Mortality, morbidity and quality of life during the 2 postoperative years

    during the 2 postoperative years

Study Arms (2)

1

laparoscopic surgery in right colon cancer operations

2

open surgery in right colon cancer operations

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Right colon cancer \< T4 without metastasis needing colectomy

You may qualify if:

  • Age ≥18 years old \<= 80 years old
  • Right colon cancer \< T4 without metastasis
  • \<T4 N0M0

You may not qualify if:

  • Pregnant patient
  • T4 cancer
  • Metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié-Salpetrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Laurent Hannoun, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

September 1, 2009

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

November 20, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)