Condition category
Cancer
Date applied
09/01/2010
Date assigned
20/01/2010
Last edited
11/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Javier Padillo

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Robotic-assisted laparoscopic surgery versus conventional laparoscopic surgery in colorectal carcinoma resection: a prospective randomised study

Acronym

RSCRC

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A minimum of 25 per group (56 in total)

Participant exclusion criteria

Stage IV tumours

Recruitment start date

01/01/2008

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Servicio de Cirugia General
Sevilla
41013
Spain

Sponsor information

Organisation

Virgen del Rocio University Hospital (Hospital Universitario Virgen del Rocío) (Spain)

Sponsor details

Manuel Siurot S/N
Sevilla
41013
Spain
+34 629 15 26 88
javierpadilloruiz@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.huvr.es/

Funders

Funder type

Hospital/treatment centre

Funder name

Virgen del Rocio University Hospital (Hospital Universitario Virgen del Rocío) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21530948

Publication citations

  1. Results

    Jiménez Rodríguez RM, Díaz Pavón JM, de La Portilla de Juan F, Prendes Sillero E, Hisnard Cadet Dussort JM, Padillo J, [Prospective randomised study: robotic-assisted versus conventional laparoscopic surgery in colorectal cancer resection]., Cir Esp, 89, 7, 432-438, doi: 10.1016/j.ciresp.2011.01.017.

Additional files

Editorial Notes