Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of the present study is to compare in the long-term costs of laparoscopic and open right cancer colectomy as well as the mortality the morbidity and the quality of life of the operated patients.

The number of patients need to get a 54% power is 300. The average number of patients/surgical center is approximately 27 in 14 surgical centers.

The proposed undertaking of every patient is fully identical to that which is usually proposed by the surgical center in charge of the patient (i.d. 7 centers will perform laparoscopic procedures and 7 centers open procedure according to their usual practice).

A complete information leaflet will be given to the patients during the first consultation which will correspond to the enrollment day.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.

On every consultation the patient will fill a very simple validated quality of life questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising medical and surgical events.

Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer will be performed controling for the carcinologic equivalence of the two surgical strategies.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Colon Cancer Surgery Laparoscopy Open surgery Costs Mortality Morbidity Quality of life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

laparoscopic surgery in right colon cancer operations

No interventions assigned to this group

2

open surgery in right colon cancer operations

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Pregnant patient
* T4 cancer
* Metastasis

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent Hannoun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pitié-Salpetrière Hospital

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STIC ICO711

Identifier Type: -

Identifier Source: org_study_id