Clinical trial NCT01772407: Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?
Official title: Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Colon Cancer Surgery
Laparoscopy
Open surgery
Costs
Mortality
Morbidity
Quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Right colon cancer \< T4 without metastasis needing colectomy

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant patient
* T4 cancer
* Metastasis

Primary outcomes:
measure: Cost during the 2 postoperative years
timeFrame: during the 2 postoperative years
Secondary outcomes:
measure: Mortality, morbidity and quality of life during the 2 postoperative years
timeFrame: during the 2 postoperative years
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié-Salpetrière Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent Hannoun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: