|
ISRCTN
|
ISRCTN60866560
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Robotic Surgery in ColoRectal Cancer
|
|
Scientific title
|
Robotic-assisted laparoscopic surgery versus conventional laparoscopic surgery in colorectal carcinoma resection: a prospective randomised study
|
|
Acronym
|
RSCRC
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
To analyse the safety and efficacy of robot-assisted laparoscopic surgery (Da Vinci) versus conventional laparoscopy in colorectal surgery.
|
|
Ethics approval
|
Hospital Clinical Trials and Ethics Committee of the University Hospital Virgen del Rocio and the Technology Assessment Agency Government of the Junta de Andalucia approved of this trial in 2007
|
|
Study design
|
Prospective randomised controlled trial
|
|
Countries of recruitment
|
Spain
|
|
Disease/condition/study domain
|
Colorectal carcinoma
|
|
Participants - inclusion criteria
|
1. Tumours located in sigmoid colon or rectosigmoid junction
2. Patients younger than 80 years, either sex
3. Patients with American Society of Anaesthesiologists (ASA) grade not superior to III
4. Patients with body mass index (BMI) less than 30 kg/m^2
|
|
Participants - exclusion criteria
|
Stage IV tumours
|
|
Anticipated start date
|
01/01/2008
|
|
Anticipated end date
|
31/12/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
A minimum of 25 per group (56 in total)
|
|
Interventions
|
Following confirmation of the inclusion criteria, patients will be randomised by computer. Patients will be randomised in two groups according to whether patients underwent a colectomy with robotic assistance or not. Robotic surgery will be performed by three laparoscopic experienced surgeons of the Surgery Department of HU Virgen del Rocio. Specific training in robotic surgery was done in a specialised centre for training (IRCAD, Strasbourg). Laparoscopic interventions will be performed by two surgeons who also had extensive experience in laparoscopic colorectal surgery.The surgical technique will be similar in both groups.
|
|
Primary outcome measure(s)
|
Morbidity and mortality. Parameters will be determined during operation and in the post-operative time.
|
|
Secondary outcome measure(s)
|
Oncologic determinations:
1. Size of resection
2. Distance to the resection margin
3. Lymphatic nodes
4. Post-operative staging
Parameters will be determined during operation and in the post-operative time.
|
|
Sources of funding
|
Virgen del Rocio University Hospital (Hospital Universitario Virgen del Rocío) (Spain)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Javier
Padillo
|
|
Address
|
Servicio de Cirugia General
3ª Planta de Hospital General ala Norte
Hospital Universitario Virgen del Rocio
C/Manuel Siurot S/N
|
|
City/town
|
Sevilla
|
|
Zip/Postcode
|
41013
|
|
Country
|
Spain
|
|
Email
|
javierpadilloruiz@gmail.com
|
|
Sponsor
|
Virgen del Rocio University Hospital (Hospital Universitario Virgen del Rocío) (Spain)
|
|
Address
|
Manuel Siurot S/N
|
|
City/town
|
Sevilla
|
|
Zip/Postcode
|
41013
|
|
Country
|
Spain
|
|
Tel
|
+34 629 15 26 88
|
|
Email
|
javierpadilloruiz@gmail.com
|
|
Sponsor website:
|
http://www.huvr.es/
|
|
Date applied
|
09/01/2010
|
|
Last edited
|
20/01/2010
|
|
Date ISRCTN assigned
|
20/01/2010
|
