Adult PatientsANACO IINCT05643105
Anastomotic Leakage After Colon Cancer Surgery
An observational study of Adult Patients and Intestinal Continuity (Anastomosis), run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Anastomotic leak (AL) is one of the most feared complications after colon cancer (CC) surgery. The incidence varies according to the studies, the definition used and the location of the excised segment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adult Patients, Intestinal Continuity (Anastomosis), Colon Cancer
- What is being tested?
- Any kind of colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,628 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2022to 1 Dec 2024
- How long will I take part?
- 12 Months
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncologic surgery for colon cancer located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery
Who may be able to join
- >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed in the same surgery.
Who cannot join
- Derivative stoma in the same surgery
- Palliative surgery
- Definitive stoma creation without anastomosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Multicenter Study of Anastomotic Leakage After Colon Cancer Surgery (ANACO II).
Anastomotic leak (AL) is one of the most feared complications after colon cancer (CC) surgery. The incidence varies according to the studies, the definition used and the location of the excised segment.
In some of the series described, AL incidence have hardly changed, despite the evolution of the technique and technological improvements. The leak rate obtained in the only Spanish prospective multicenter observational study at national level was 9% (ANACO study).
Read more
The aim of the present study is to determine the current rate of AL in our country, 10 years after the ANACO study, to determine if there has been any evolution and to analyze the factors associated with it. For this purpose, AL is defined with the same criteria as in the first study, as leakage of luminal contents through the junction between two hollow visceras, diagnosed radiologically (radiography with soluble enema or CT with collection adjacent to the anastomosis), clinically (extravasation of luminal contents or gas through the wound or drainage), endoscopically or intraoperatively. To compare AL rates throughout this decade, a 60-day follow-up will be performed, the same as in the ANACO study.
As a modification respect to the ANACO study protocol, the aim is to analyze the possible influence of AL and perioperative intra-abdominal infection on short-term oncologic prognosis, with a one-year follow-up. This question has hardly been studied in prospective multicenter studies to date.
The variables to be collected are divided into demographic (information about the hospital center, patient comorbidities), diagnostic variables (analytical values, diagnostic reason, neoadjuvant, localization, TNM), surgical variables (type of surgery, preparation, intention, intraoperative findings and complications, type of resection and anastomosis), admission (AL, other complications), histology, 60-day follow-up (AL, readmissions), one-year follow-up (readmissions, local recurrence, peritoneal and distant recurrence).
Patients included in the study must be >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed and a derivative stoma should not be associated in the same surgery. According to ANACO data and follow-up times according to the primary objective (AL) at 60 days and the secondary objective (oncologic prognosis) with annual follow-up, inclusion will be carried out until the 1628 individuals required according to the sample size calculation performed are included.
- Being tested
- Any kind of colectomy
- Keywords
- colon cancer, anastomotic leakage
- Medical subject headings
- Colonic Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any kind of colectomyProcedure or surgery
Also called Adjuvant chemotherapy when necessary following current clinical practice
This is a registry of surgical patients with colon cancer that are managed following current clinical practice in each participating center. The aim of this research is studying anastomotic leak rates and posible risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Colon cancer patients with intestinal anastomosis | There is a single cohort of patients, the one operated on for colon cancer with intestinal continuity construction through an anastomosis without derivative stoma construction of any kind. Receives: Procedure: Any kind of colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak
Measured: 60 days
Secondary outcomes (2)
Overall postoperative complications
Measured: 60 days
Local recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start15 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult PatientsStudies 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
- 1,628 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC), Hospital Universitario La Fe, Complejo Hospitalario Universitario de Vigo
- Responsible party
- Principal investigator, Carlos Cerdán Santacruz, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- Carlos Cerdán, MD PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643105
- Sponsor's protocol ID
- 10/22-4851
- Acronym
- ANACO II
- Status last verified
- Sep 2023
- First submitted
- 22 Nov 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is the intention of the authors to share data collected through an official data repository such as Mendeley, for example.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Multicenter Study of Anastomotic Leakage After Colon Cancer Surgery (ANACO II).
- ClinicalTrials.gov ID
- NCT05643105
- Acronym / sponsor ID
- ANACO II / 10/22-4851
- Keywords
- colon cancer, anastomotic leakage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,628 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Spanish Association of Surgeons (AEC), Hospital Universitario La Fe, Complejo Hospitalario Universitario de Vigo
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Dec 2022 (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.
Anastomotic leak (AL) is one of the most feared complications after colon cancer (CC) surgery. The incidence varies according to the studies, the definition used and the location of the excised segment.
In some of the series described, AL incidence have hardly changed, despite the evolution of the technique and technological improvements. The leak rate obtained in the only Spanish prospective multicenter observational study at national level was 9% (ANACO study).
The aim of the present study is to determine the current rate of AL in our country, 10 years after the ANACO study, to determine if there has been any evolution and to analyze the factors associated with it. For this purpose, AL is defined with the same criteria as in the first study, as leakage of luminal contents through the junction between two hollow visceras, diagnosed radiologically (radiography with soluble enema or CT with collection adjacent to the anastomosis), clinically (extravasation of luminal contents or gas through the wound or drainage), endoscopically or intraoperatively. To compare AL rates throughout this decade, a 60-day follow-up will be performed, the same as in the ANACO study.
As a modification respect to the ANACO study protocol, the aim is to analyze the possible influence of AL and perioperative intra-abdominal infection on short-term oncologic prognosis, with a one-year follow-up. This question has hardly been studied in prospective multicenter studies to date.
The variables to be collected are divided into demographic (information about the hospital center, patient comorbidities), diagnostic variables (analytical values, diagnostic reason, neoadjuvant, localization, TNM), surgical variables (type of surgery, preparation, intention, intraoperative findings and complications, type of resection and anastomosis), admission (AL, other complications), histology, 60-day follow-up (AL, readmissions), one-year follow-up (readmissions, local recurrence, peritoneal and distant recurrence).
Patients included in the study must be >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed and a derivative stoma should not be associated in the same surgery. According to ANACO data and follow-up times according to the primary objective (AL) at 60 days and the secondary objective (oncologic prognosis) with annual follow-up, inclusion will be carried out until the 1628 individuals required according to the sample size calculation performed are included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colon cancer patients with intestinal anastomosis | – | Procedure: Any kind of colectomyThere is a single cohort of patients, the one operated on for colon cancer with intestinal continuity construction through an anastomosis without derivative stoma construction of any kind. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncologic surgery for colon cancer located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery
Key inclusion criteria (1 listed)
- >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed in the same surgery.
Key exclusion criteria (3 listed)
- Derivative stoma in the same surgery
- Palliative surgery
- Definitive stoma creation without anastomosis
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 |
|---|---|---|
| Any kind of colectomyAlso: Adjuvant chemotherapy when necessary following current clinical practiceThis is a registry of surgical patients with colon cancer that are managed following current clinical practice in each participating center. The aim of this research is studying anastomotic leak rates and posible risk factors. | Procedure or surgery | Colon cancer patients with intestinal anastomosis |
Primary outcome
Anastomotic leak
Time frame: 60 days
2 secondary outcomes
Overall postoperative complications
Time frame: 60 days
Local recurrence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Yes. It is the intention of the authors to share data collected through an official data repository such as Mendeley, for example.
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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.
Carlos Cerdán, MD PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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 Adult Patients and Intestinal Continuity (Anastomosis), run by Hospital San Carlos, Madrid 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 3 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 22 Sep 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.