Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)
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Purpose
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
| Condition |
|---|
|
Colon Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life |
- Cost during the 2 postoperative years [ Time Frame: during the 2 postoperative years ] [ Designated as safety issue: No ]
- Mortality, morbidity and quality of life during the 2 postoperative years [ Time Frame: during the 2 postoperative years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
laparoscopic surgery in right colon cancer operations
|
|
2
open surgery in right colon cancer operations
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Right colon cancer < T4 without metastasis needing colectomy
Inclusion Criteria:
- Age ≥18 years old <= 80 years old
- Right colon cancer < T4 without metastasis
- <T4 N0M0
Exclusion Criteria:
- Pregnant patient
- T4 cancer
- Metastasis
Contacts and Locations| Contact: Jean_Jacques Duron, MD, PhD | 33142175622 | jean-jacques.duron@psl.aphp.fr |
| France | |
| Pitié-Salpetrière Hospital | Recruiting |
| Paris, France, 75013 | |
| Sub-Investigator: Jean-Jacques Duron, MD, PhD | |
| Principal Investigator: | Laurent Hannoun, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01772407 History of Changes |
| Other Study ID Numbers: | STIC ICO711 |
| Study First Received: | January 17, 2013 |
| Last Updated: | January 17, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Colon Cancer Surgery Laparoscopy Open surgery Costs |
Mortality Morbidity Quality of life |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013