EAST-west Colorectal Study

Not yet recruiting

• Conditions: Colorectal Anastomosis

• Registration Number: NCT05544487
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-10
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-16
• Status Verified: 2022-10
• Study Start: 2022-10-01
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10
• Primary Completion: 2023-02-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Leakage rate	30 days

Secondary Outcome Measures

Name	Time	Method
30-day postoperative morbidity	30 days
Clavien-Dindo complication classification	30 days
Re-admission rate within the first 30 days post-surgery.	30 days
Length of stay	30 days
30-day postoperative mortality	30 days