Anastomotic Leakage After Colon Cancer Surgery

NCT05643105 | Unknown

• 1 other identifier: 10/22-4851
• Study Type: observational
• Target: 1,628
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adult Patients; Intestinal Continuity (Anastomosis); Colon Cancer

Keywords

colon cancer; anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak

  60 days

Secondary Outcomes (2)

• Overall postoperative complications

  60 days

• Local recurrence

  1 year

Other Outcomes (2)

• Minimally invasive surgery use

  1 day

• Intraoperative complications

  7 days

Study Arms (1)

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

Interventions

Any kind of colectomy PROCEDURE

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.

Also known as: Adjuvant chemotherapy when necessary following current clinical practice

Colon cancer patients with intestinal anastomosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \>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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Spanish Association of Surgeons (AEC): collaborator
• Hospital Universitario La Fe: collaborator
• Complejo Hospitalario Universitario de Vigo: collaborator

Study Sites (1)

Carlos Cerdán Santacruz

Madrid, 28029, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Cerdán, MD PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant. Colorectal Surgery Department. Principal Investigator

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 8, 2022
• Study Start: December 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From three months after recruitment after 3 months of follow-up ending.
• Access Criteria: Under demand.

Locations

ES (1)