Robotic Surgery in ColoRectal Cancer
| ISRCTN | ISRCTN60866560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60866560 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/01/2010
- Registration date
- 20/01/2010
- Last edited
- 11/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Javier Padillo
Scientific
Scientific
Servicio de Cirugia General
3ª Planta de Hospital General ala Norte
Hospital Universitario Virgen del Rocio
C/Manuel Siurot S/N
Sevilla
41013
Spain
| javierpadilloruiz@gmail.com |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Robotic-assisted laparoscopic surgery versus conventional laparoscopic surgery in colorectal carcinoma resection: a prospective randomised study |
| Study acronym | RSCRC |
| Study objectives | To analyse the safety and efficacy of robot-assisted laparoscopic surgery (Da Vinci) versus conventional laparoscopy in colorectal surgery. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Colorectal carcinoma |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Morbidity and mortality. Parameters will be determined during operation and in the post-operative time. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/01/2008 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A minimum of 25 per group (56 in total) |
| Key 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 |
| Key exclusion criteria | Stage IV tumours |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Servicio de Cirugia General
Sevilla
41013
Spain
41013
Spain
Sponsor information
Virgen del Rocio University Hospital (Hospital Universitario Virgen del Rocío) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Manuel Siurot S/N
Sevilla
41013
Spain
| Phone | +34 629 15 26 88 |
|---|---|
| javierpadilloruiz@gmail.com | |
| Website | http://www.huvr.es/ |
"ROR" |
https://ror.org/04vfhnm78 |
Funders
Funder type
Hospital/treatment centre
Virgen del Rocio University Hospital (Hospital Universitario Virgen del Rocío) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No |
