Anastomotic Leakage After Colon Cancer Surgery (ANACO II)

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).

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 Overview

• Status: Enrolling by invitation
• Conditions: Colon Cancer; Adult Patients; Intestinal Continuity (Anastomosis)
• Intervention / Treatment: Procedure: Any kind of colectomy

• Study Type: Observational
• Enrollment (Estimated): 1628

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28029
    • Carlos Cerdán Santacruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• >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.

Exclusion Criteria:

• Derivative stoma in the same surgery
• Palliative surgery
• Definitive stoma creation without anastomosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Any kind of colectomy; 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.; Other Names: Adjuvant chemotherapy when necessary following current clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anastomotic leak	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall postoperative complications	60 days
Local recurrence	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimally invasive surgery use	Amount of patients that are operated on for colon cancer using minimally invasive approaches, both laparoscopic or robotic	1 day
Intraoperative complications		7 days

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid
• Collaborators: Hospital Universitario La Fe; Spanish Association of Surgeons (AEC); Complejo Hospitalario Universitario de Vigo
• Investigators: Principal Investigator: Carlos Cerdán, MD PhD, Hospital de La Princesa

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: colon cancer; anastomotic leakage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Anastomotic Leak; Colonic Neoplasms
• Other Study ID Numbers: 10/22-4851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is the intention of the authors to share data collected through an official data repository such as Mendeley, for example.
• IPD Sharing Time Frame: From three months after recruitment after 3 months of follow-up ending.
• IPD Sharing Access Criteria: Under demand.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No