Colon CancerRIAL-COLECTOMYNCT04456933
Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study
An observational study of Colon Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Extracorporeal left hemicolectomy anastomosis and Intracorporeal left hemicolectomy anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jun 2020to 28 Feb 2022
- 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: In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique. In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.
Who may be able to join
- Left Colonic Adenocarcinoma. Location of the tumor in the left colon, sigma or high rectum (with the anastomosis performed above the peritoneal reflection). Non-metastatic stage. Scheduled oncological surgery with curative intention operated on with laparoscopic surgery with resection technique and intracorporeal anastomosis. Over 18 years
Who cannot join
- Other tumor locations. Non-adenocarcinoma tumors. Synchronous tumors. T4 tumor stage and stage IV of TNM classification. ASA IV (American Society of Anesthesiologists). Non-optimal nutritional study (preoperative albumin ≤3.4 g / dl). Do not sign informed consent. Pregnant patients. Diagnosis of another type of neoplasm with active disease. Liver cirrhosis, Chronic kidney failure on dialysis treatment, patients with stent bridge to elective surgery.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Parc Tauli de Sabadel
Sabadell, Barceelona, 08208
Xavier Serra-Aracil, MD,PhD, 937 231 010 ext. 21490, jserraa@tauli.cat
About this study
Official title: RESECTION AND INTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC LEFT COLECTOMY AS AN ADAPTATION TO THE PANDEMIC CAUSED BY SARS-CoV-2 (COVID19). A COMPARATIVE COHORT STUDY
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage.
BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible.
Read more
Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis.
METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.
Read the detailed description
HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise of the anastomosis, a smaller incision size and being able to choose its location.
Main Aim:
The objective of this study is to demonstrate that colorectal mechanical end-to-end intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic dehiscence.
Secondary Aims:
- To demonstrate the reproducibility of the colorectal mechanical end-to-end intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence, organo-cavitary infection, and other postoperative complications.
- To determine the benefits that the IC anastomosis technique can bring to patients with obesity.
- To determine the benefits that the IC anastomosis technique can provide in terms of postoperative complications, hospital stay, and size of the accessory incision.
- To determine the benefit of the application of indocyanine green to determine the point of resection and anastomosis.
STUDY DESIGN
Comparative, single-center, controlled non-inferiority cohort study of resection and mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic surgery (retrospective cohort).
SUBJECTS OF THE STUDY
In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.
In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.
- Conditions
- Colon Cancer
- Being tested
- Extracorporeal left hemicolectomy anastomosis, Intracorporeal left hemicolectomy anastomosis
- Keywords
- Left Colon Cancer,, Left hemicolectomy, Laparoscopic left hemicolectomy, Intracorporeal resection and anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal left hemicolectomy anastomosisProcedure or surgery
Standard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years.
After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun®
Intracorporeal left hemicolectomy anastomosisProcedure or surgery
- Intracorporeal resection of the left mesocolon
The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm)
- Preparation of Intracorporeal Anastomosis
The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®.
The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made.
Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed.
The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient)
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of anastomotic leak (AL)
Percentage of anastomic leak (defined in accordance with Peel et al.).
Measured: 30 days
Secondary outcomes (3)
Rate of global morbidity
Dindo-Clavien Classification
Measured: 30 days
Rate of Surgical site infection
SSI in accordance with the Center for Disease Control (CDC) National
Measured: 30 days
Rate of Re-interventions
Percentage of re-interventions due to surgical complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start29 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Irene Gómez Torres, Laura Mora López, Anna Pallisera-Lloveras, Sheila Serra-Pla, Albert García Nalda, Anna Serracant-Barrera, Mercedes Muñoz, Oriol Pino-Pérez
- Responsible party
- Principal investigator, Xavier Serra-Aracil, Corporacion Parc Tauli
- Investigators
- Xavier Serra-Aracil, MD,PhD, Principal investigator, Corporacio Parc Tauli. Parc Tauli University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456933
- Sponsor's protocol ID
- HEMI-E-INTRACORPOREA-2020
- Acronym
- RIAL-COLECTOMY
- Status last verified
- Nov 2021
- First submitted
- 30 Jun 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.
PubMed 25814073Akamatsu H, Omori T, Oyama T, Tori M, Ueshima S, Nakahara M, Abe T, Nishida T. Totally laparoscopic sigmoid colectomy: a simple and safe technique for intracorporeal anastomosis. Surg Endosc. 2009 Nov;23(11):2605-9. doi: 10.1007/s00464-009-0406-6. Epub 2009 Mar 6.
PubMed 19266229
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESECTION AND INTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC LEFT COLECTOMY AS AN ADAPTATION TO THE PANDEMIC CAUSED BY SARS-CoV-2 (COVID19). A COMPARATIVE COHORT STUDY
- ClinicalTrials.gov ID
- NCT04456933
- Acronym / sponsor ID
- RIAL-COLECTOMY / HEMI-E-INTRACORPOREA-2020
- Conditions
- Colon Cancer
- Keywords
- Left Colon Cancer,, Left hemicolectomy, Laparoscopic left hemicolectomy, Intracorporeal resection and anastomosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Irene Gómez Torres, Laura Mora López, Anna Pallisera-Lloveras, Sheila Serra-Pla, Albert García Nalda, Anna Serracant-Barrera, Mercedes Muñoz, Oriol Pino-Pérez
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 7 Jul 2020 (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.
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage.
BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible.
Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis.
METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.
Detailed description
HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise of the anastomosis, a smaller incision size and being able to choose its location.
Main Aim:
The objective of this study is to demonstrate that colorectal mechanical end-to-end intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic dehiscence.
Secondary Aims:
- To demonstrate the reproducibility of the colorectal mechanical end-to-end intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence, organo-cavitary infection, and other postoperative complications.
- To determine the benefits that the IC anastomosis technique can bring to patients with obesity.
- To determine the benefits that the IC anastomosis technique can provide in terms of postoperative complications, hospital stay, and size of the accessory incision.
- To determine the benefit of the application of indocyanine green to determine the point of resection and anastomosis.
STUDY DESIGN
Comparative, single-center, controlled non-inferiority cohort study of resection and mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic surgery (retrospective cohort).
SUBJECTS OF THE STUDY
In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.
In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique. In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.
Key inclusion criteria (1 listed)
- Left Colonic Adenocarcinoma. Location of the tumor in the left colon, sigma or high rectum (with the anastomosis performed above the peritoneal reflection). Non-metastatic stage. Scheduled oncological surgery with curative intention operated on with laparoscopic surgery with resection technique and intracorporeal anastomosis. Over 18 years
Key exclusion criteria (1 listed)
- Other tumor locations. Non-adenocarcinoma tumors. Synchronous tumors. T4 tumor stage and stage IV of TNM classification. ASA IV (American Society of Anesthesiologists). Non-optimal nutritional study (preoperative albumin ≤3.4 g / dl). Do not sign informed consent. Pregnant patients. Diagnosis of another type of neoplasm with active disease. Liver cirrhosis, Chronic kidney failure on dialysis treatment, patients with stent bridge to elective surgery.
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 left hemicolectomy anastomosisStandard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years. After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun® | Procedure or surgery | – |
| Intracorporeal left hemicolectomy anastomosiso Intracorporeal resection of the left mesocolon The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm) o Preparation of Intracorporeal Anastomosis The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®. The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made. Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed. The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient) | Procedure or surgery | – |
Primary outcome
Percentage of anastomotic leak (AL)
Time frame: 30 days
Percentage of anastomic leak (defined in accordance with Peel et al.).
3 secondary outcomes
Rate of global morbidity
Time frame: 30 days
Rate of Surgical site infection
Time frame: 30 days
Rate of Re-interventions
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Background: PubMed 25814073Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.
- Background: PubMed 19266229Akamatsu H, Omori T, Oyama T, Tori M, Ueshima S, Nakahara M, Abe T, Nishida T. Totally laparoscopic sigmoid colectomy: a simple and safe technique for intracorporeal anastomosis. Surg Endosc. 2009 Nov;23(11):2605-9. doi: 10.1007/s00464-009-0406-6. Epub 2009 Mar 6.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Xavier Serra-Aracil, MD,PhD principal investigator
Corporacio Parc Tauli. Parc Tauli University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 1 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 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 Xavier Serra-Aracil, MD,PhD (34-93-723-1010 ext. 21490, jserraa@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of anastomotic leak (AL) (time frame: 30 days). 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 NCT04456933, which also lists 2 linked publications.
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 16 Nov 2021.