Colorectal CancerMIRCASTNCT03650517
Minimally Invasive Right Colectomy Anastomosis Study
An observational study of Colorectal Cancer and Anastomotic Complication, run by Instituto de Investigación Marqués de Valdecilla at 32 sites in 10 countries.
Trial summary
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Anastomotic Complication, Colectomy
- What is being tested?
- Extracorporeal Anastomosis, Intracorporeal Anastomosis and Robotic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 32 sitesin 10 countries
- Study dates
- 1 Nov 2018to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Right colon tumor with indication for right colectomy
Who may be able to join
- 18 years or older.
- Right colon tumor with indication for right colectomy (benign or malignant disease)
- Patient has a life expectancy of at least 12 weeks
- Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
- Patient has signed and dated the Informed consent before patient inclusion in the study
Who cannot join
- Patient with a comorbid illness or condition that would preclude the use of surgery
- Patients with cT4b tumors
- Patients unwilling to comply with all follow-up study requirements
- Patient undergoing emergency procedures
- Planned colonic surgery along with major concomitant procedures (e.g. liver resections, other intestinal resections)
- Metastatic disease
- Pregnant or suspected pregnancy
- Inflammatory Bowel Disease (Crohn´s Disease or Ulcerative Colitis)
Trial locations and contacts
32 sites in 10 countries.
Lucía Lavín Alconero, BSc PhD contact
32 sites in 10 countries
Spain9 sites, 9 recruiting
- Recruiting
Complejo hospitalario de Torrecardenas
Almería
Pedro Antonio Sanchez Fuentes, MD
Angel Reina Duarte
- Recruiting
Hospital Universitario Vall d´hebron
Barcelona, Catalonia
Eloy Espin
Franco Marinello
- Recruiting
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country
Carlos Placer Galán
José María Enriquez Navascues
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante
Antonio Arroyo Sebastián, MD
Antonio Arroyo Sebastián
- Recruiting
Hospital de León
León
Vicente Simó Fernández
Vicente Simó Fernández
- Recruiting
Hospital Clínico San Carlos
Madrid
Mauricio García Alonso, MD
Oscar Cano Valderrama
- Recruiting
Hospital Universitario 12 de octubre
Madrid
Eduardo Rubio Gonzalez
Oscar García Villar
- Recruiting
Hospital Central de Asturias
Oviedo, Principality of Asturias
Nuria Truan Alonso
Nuria Truan Alonso
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Marcos Gómez Ruiz, MD
Carmen Cagigas Fernández
Italy6 sites, 6 recruiting
- Not yet recruiting
AOU-Careggi
Florence
Andrea Coratti
- Recruiting
Ospedale La Misericordia
Grosseto
Paolo Pietro Bianchi, MD PhD
- Recruiting
IEO - European Institute of Oncology
Milan
Wanda Luisa Petz
- Recruiting
Policlínico Agostino Gemelli
Roma
Dominico D´Ugo
- Recruiting
Humanitas Research Hospital
Rozzano
Antonino Spinelli
- Not yet recruiting
IRCCS Istituto di Candiolo
Torino
Dario RIBERO
Finland5 sites, 5 recruiting
- Not yet recruiting
Kanta-Hämeen Keskussairaala
Hämeenlinna
Arto Turunen
- Recruiting
Kymenlaakso Central Hospital
Kotka
Pälvi Vento
- Recruiting
Päijät-Häme Central Hospital
Lahti
Jyrki Kössi
- Recruiting
Oulu University Hospital
Oulu
Tero Rautio
- Recruiting
Seinäjoki Central Hospital
Seinäjoki
Tarja Pinta
France5 sites, 4 recruiting
- Active, not recruiting
Hôpital Haut-Lévèque- CHU
Bordeaux
- Not yet recruiting
CHU Estaing
Clermont-Ferrand
Anne DUBOIS
- Recruiting
ICM - Institut Régional du Cancer de Montpellier
Montpellier
Philippe ROUANET
- Not yet recruiting
CHRU de Strasbourg Hôpital Civil
Strasbourg
Benoit ROMAIN Benoit
- Not yet recruiting
CHRU Nancy Brabois
Vandœuvre-lès-Nancy
Laurent BRESLER
Denmark2 sites
- Active, not recruiting
Hospital of Southern Denmark
Aabenraa
- Active, not recruiting
Zealand University Hospital
Køge
Germany1 site, 1 recruiting
- Not yet recruiting
Medizinische Hochschule Hannover
Hanover
Markus Winny
Greece1 site, 1 recruiting
- Recruiting
Eurokliniki Athinou
Athens, Athina
Thalia Petropoulou
Portugal1 site, 1 recruiting
- Not yet recruiting
Centro Hospitalar de Leiria
Leiria
Nuno Rama
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Portsmouth Hospital NHS Trust
Portsmouth
Jim Kahn
About this study
Official title: A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.
A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.
Read more
However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.
MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:
- Robotic Right Colectomy with ICA
- Robotic Right Colectomy with ECA
- Laparoscopic Right Colectomy with ICA
- Laparoscopic Right Colectomy with ECA
All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.
Read the detailed description
MIRCAST study is an observational, prospective, parallel cohorts, international, multi-center to compare robotic assisted and laparoscopic minimally invasive right colectomy, and intracorporeal anastomosis versus extracorporeal anastomosis.
The research is coordinated by Marcos Gómez Ruiz MD PhD from Hospital Universitario Marqués de Valdecilla in Santander, Spain; the sponsorship is performed by Fundacion Instituto de Investigación Marqués de Valdecilla (IDIVAL). The European Society of Coloproctology (ESCP) endorses MIRCAST Study and will run a quality audit/independent monitoring of the study.
The objectives of study are to compare of the peri-operative complications after robotic assisted and laparoscopic minimally invasive right colectomy with intracorporeal anastomosis versus extracorporeal anastomosis.
To Identify potential benefits of robotic assisted procedures for right colon resections.
- Conditions
- Colorectal Cancer, Anastomotic Complication, Colectomy
- Being tested
- Extracorporeal Anastomosis, Intracorporeal Anastomosis, Robotic Surgery, Laparoscopic Surgery
- Keywords
- Laparoscopic, Robotic, Right colon tumor, Anastomosis, Intracorporeal, Extracorporeal
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal AnastomosisProcedure or surgery
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
Intracorporeal AnastomosisProcedure or surgery
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
Robotic SurgeryProcedure or surgery
Procedure is performed using robotic instruments
Laparoscopic SurgeryProcedure or surgery
Procedure is performed using standard laparoscopic instruments
| Study group | Role | What they receive |
|---|---|---|
| Robotic Right Colectomy with ICA | Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.
Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction. Receives: Procedure: Intracorporeal Anastomosis; Procedure: Robotic Surgery | |
| Robotic Right Colectomy with ECA | Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.
Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed. Receives: Procedure: Extracorporeal Anastomosis; Procedure: Robotic Surgery | |
| Laparoscopic Right Colectomy with ICA | Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.
Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction. Receives: Procedure: Intracorporeal Anastomosis; Procedure: Laparoscopic Surgery | |
| Laparoscopic Right Colectomy with ECA | Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.
Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed. Receives: Procedure: Extracorporeal Anastomosis; Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical wound infection
(CDC definition [Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus.
Measured: 30 days
Clavien Dindo Complication
Complications according to Clavien Dindo Classification.
Measured: 30 days
Secondary outcomes (14)
Overall Survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive
Measured: 2 years
Disease Free Survival (DFS)
Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Measured: 2 years
Local Recurrence rate
Rate of cancer that has recurred at or near the same place as the original (primary) tumor
Measured: 2 years
Distant metastases rate
Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes
Measured: 2 years
Rate of Unplanned Conversions to open surgery
When anything apart of the anastomosis had to be done through the laparotomy. If the anastomosis is not completely performed in an intracorporeal approach, the case is considered also converted
Measured: 7 days
Operative time (min)
Operative time from skin to skin in minutes
Measured: 7 days
Complete mesocolic excision (CME)
Complete Mesocolic Excision is defined as complete resection of the mesocolon with its anatomical envelope. Anatomical report should include any defect on CME specimen (Hohenberger W, Weber K., Matzel K., Papadopoulost T., Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation - technical notes and outcome. Colorectal Disease 11, 354-365 2008. doi:10.1111/j.1463-1318.2008.01735.x)
Measured: 30 days
Number of Harvested Lymph Nodes
Number of harvested Lymph nodes according to the definitive pathological report.
Measured: 30 days
R0 Resection
Rate of resection without any affected margins during the surgical procedure.
Measured: 30 days
Length of Stay (LOS, days)
In hospital stay of the patient from the day that they are admitted before surgery to the day that they are fit to leave the hospital after the procedure.
Measured: 3 months
Ventral hernia (assessed 1& 2 years after the right colectomy)
Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site.
Measured: 1 and 2 years after the procedure
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure.
Measured: 3 months and 1 year after the procedure
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 Score 3 months and 1 year after the procedure.
Measured: 3 months and 1 year after the procedure
C-Reactive Protein value (CRP) days 1 & 3 postoperative
CRP values on postoperative day 1 and 3.
Measured: 1 and 3 postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Nov 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcos Gómez Ruiz, MD PhD, Principal investigator, Hospital Universitario Marqués de Valdecilla, IDIVALGalo Peralta, MD, Study chair, Instituto de Investigación Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650517
- Sponsor's protocol ID
- IDIVAL CI18/27
- Acronym
- MIRCAST
- Status last verified
- Sep 2019
- First submitted
- 16 Jul 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, Gogenur I, Jayne D, Khan JS, Rautio T, Sanchez-Guillen L, Spinoglio G, Ulrich A, Rouanet P. Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor. BMC Surg. 2020 Jul 13;20(1):151. doi: 10.1186/s12893-020-00803-x.
PubMed 32660467
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis
- ClinicalTrials.gov ID
- NCT03650517
- Acronym / sponsor ID
- MIRCAST / IDIVAL CI18/27
- Conditions
- Colorectal Cancer, Anastomotic Complication, Colectomy
- Keywords
- Laparoscopic, Robotic, Right colon tumor, Anastomosis, Intracorporeal, Extracorporeal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.
A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.
However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.
MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:
- Robotic Right Colectomy with ICA
- Robotic Right Colectomy with ECA
- Laparoscopic Right Colectomy with ICA
- Laparoscopic Right Colectomy with ECA
All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.
Detailed description
MIRCAST study is an observational, prospective, parallel cohorts, international, multi-center to compare robotic assisted and laparoscopic minimally invasive right colectomy, and intracorporeal anastomosis versus extracorporeal anastomosis.
The research is coordinated by Marcos Gómez Ruiz MD PhD from Hospital Universitario Marqués de Valdecilla in Santander, Spain; the sponsorship is performed by Fundacion Instituto de Investigación Marqués de Valdecilla (IDIVAL). The European Society of Coloproctology (ESCP) endorses MIRCAST Study and will run a quality audit/independent monitoring of the study.
The objectives of study are to compare of the peri-operative complications after robotic assisted and laparoscopic minimally invasive right colectomy with intracorporeal anastomosis versus extracorporeal anastomosis.
To Identify potential benefits of robotic assisted procedures for right colon resections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Robotic Right Colectomy with ICA | – | Procedure: Intracorporeal Anastomosis, Procedure: Robotic SurgeryRobot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques. Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction. |
| Robotic Right Colectomy with ECA | – | Procedure: Extracorporeal Anastomosis, Procedure: Robotic SurgeryRobot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques. Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed. |
| Laparoscopic Right Colectomy with ICA | – | Procedure: Intracorporeal Anastomosis, Procedure: Laparoscopic SurgeryLaparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body. Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction. |
| Laparoscopic Right Colectomy with ECA | – | Procedure: Extracorporeal Anastomosis, Procedure: Laparoscopic SurgeryLaparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body. Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Right colon tumor with indication for right colectomy
Key inclusion criteria (5 listed)
- 18 years or older.
- Right colon tumor with indication for right colectomy (benign or malignant disease)
- Patient has a life expectancy of at least 12 weeks
- Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
- Patient has signed and dated the Informed consent before patient inclusion in the study
Key exclusion criteria (8 listed)
- Patient with a comorbid illness or condition that would preclude the use of surgery
- Patients with cT4b tumors
- Patients unwilling to comply with all follow-up study requirements
- Patient undergoing emergency procedures
- Planned colonic surgery along with major concomitant procedures (e.g. liver resections, other intestinal resections)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal AnastomosisAnastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed. | Procedure or surgery | Laparoscopic Right Colectomy with ECA, Robotic Right Colectomy with ECA |
| Intracorporeal AnastomosisAnastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique | Procedure or surgery | Laparoscopic Right Colectomy with ICA, Robotic Right Colectomy with ICA |
| Robotic SurgeryProcedure is performed using robotic instruments | Procedure or surgery | Robotic Right Colectomy with ECA, Robotic Right Colectomy with ICA |
| Laparoscopic SurgeryProcedure is performed using standard laparoscopic instruments | Procedure or surgery | Laparoscopic Right Colectomy with ECA, Laparoscopic Right Colectomy with ICA |
Primary outcome
Surgical wound infection
Time frame: 30 days
(CDC definition [Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus.
Clavien Dindo Complication
Time frame: 30 days
Complications according to Clavien Dindo Classification.
14 secondary outcomes
Overall Survival
Time frame: 2 years
Disease Free Survival (DFS)
Time frame: 2 years
Local Recurrence rate
Time frame: 2 years
Distant metastases rate
Time frame: 2 years
Rate of Unplanned Conversions to open surgery
Time frame: 7 days
Operative time (min)
Time frame: 7 days
Complete mesocolic excision (CME)
Time frame: 30 days
Number of Harvested Lymph Nodes
Time frame: 30 days
R0 Resection
Time frame: 30 days
Length of Stay (LOS, days)
Time frame: 3 months
Ventral hernia (assessed 1& 2 years after the right colectomy)
Time frame: 1 and 2 years after the procedure
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Time frame: 3 months and 1 year after the procedure
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29
Time frame: 3 months and 1 year after the procedure
C-Reactive Protein value (CRP) days 1 & 3 postoperative
Time frame: 1 and 3 postoperative days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 32660467Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, Gogenur I, Jayne D, Khan JS, Rautio T, Sanchez-Guillen L, Spinoglio G, Ulrich A, Rouanet P. Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor. BMC Surg. 2020 Jul 13;20(1):151. doi: 10.1186/s12893-020-00803-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucía Lavín Alconero, BSc PhD contact
Marcos Gómez Ruiz, MD PhD principal investigator
Hospital Universitario Marqués de Valdecilla, IDIVAL
Galo Peralta, MD study chair
Instituto de Investigación Marqués de Valdecilla
32 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Anastomotic Complication, run by Instituto de Investigación Marqués de Valdecilla at 32 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, Italy, Finland, France, Denmark and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos Gómez Ruiz, MD PhD (0034942202520 ext. 73733, marcos.gomez@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical wound infection (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.