EAST-west Colorectal Study

NCT05544487 | Unknown

• 1 other identifier: EAST-west 2022
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal resection due to benign and malignant diseases is a commonly performed procedure. The continuity of the gastrointestinal tract is re-established by creating an anastomosis. Although such procedures are often performed, anastomotic techniques and postoperative outcomes usually vary. Failure of the anastomosis might be a life-threatening condition after colorectal resection. A relatively high incidence of anastomotic leaks (up to 30%) has been reported worldwide. Anastomotic failure could happen due to several reasons, that are divided into surgeon-related factors and patient-related factors. So far, there has been no data about the incidence of anastomotic leak in the Western Balkans and the Mediterranean countries.The aim of EAST-WEST Colorectal Study 2022 is to investigate differences in patients undergoing colorectal resections, including pre-operative patient preparation, history of prior surgeries and anastomotic techniques. In addition, this study aims to collect data about post-operative complication rate within 30 days post-surgery across Balkan countries (Slovenia, Serbia, Macedonia, Croatia, BIH and Monte Negro), Greece, Romania and Malta, hence the study outcomes could be applicable to the Mediterranean region, in which patients share a common set of characteristics. This would enable variabilities in practice to be identified and differences regarding postoperative outcomes to be highlighted.

Conditions

Colorectal Anastomosis

Outcome Measures

Primary Outcomes (1)

• Leakage rate

  30 days

Secondary Outcomes (5)

• Re-admission rate within the first 30 days post-surgery.

  30 days

• 30-day postoperative morbidity

  30 days

• 30-day postoperative mortality

  30 days

• Clavien-Dindo complication classification

  30 days

• Length of stay

  30 days

Interventions

Colorectal Anastomosis PROCEDURE

Differences in intra-operative techniques and surgeon grades

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing colorectal anastomoses due to benign or malignant reasons.

You may qualify if:

• Adults between 18-90 years old undergoing colorectal resection with anastomosis due to benign and malignant diseases
• Any of the procedures listed below performed as an emergency or elective surgery, and by any approach; open, laparoscopic or robotic:
• Right hemicolectomy and extended right hemicolectomy
• Ileocecal resection
• Transverse colon resection
• Segmental colonic resection - i.e. splenic resection
• Left hemicolectomy
• Sigmoid resection
• Rectal resection
• Pan-proctocolectomy

You may not qualify if:

• Closure of ileostomy or colostomy
• Creation of multiple anastomoses
• Small bowel resection
• Pelvic exenteration
• Cytoreductive surgery

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Central Study Contacts

Maximos Frountzas, PhD

CONTACT

+0030 6978880045; froumax@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 16, 2022
• Study Start: October 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-10