EAST-west Colorectal Study

Colorectal Anastomosis Clinical Trial

— EAST-west  

Official title:

The Effect of Preoperative Factors and Surgical Technique on Postoperative Outcomes in Patients Undergoing Colorectal Resections at South-eastern Europe.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05544487
• Other study ID #: EAST-west 2022
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2022
• Source: National and Kapodistrian University of Athens
• Contact: Maximos Frountzas, PhD
• Phone: +0030 6978880045
• Email: froumax[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Anastomosis

Intervention

Procedure:
• Colorectal Anastomosis
Differences in intra-operative techniques and surgeon grades

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leakage rate		30 days
Secondary	Re-admission rate within the first 30 days post-surgery.		30 days
Secondary	30-day postoperative morbidity		30 days
Secondary	30-day postoperative mortality		30 days
Secondary	Clavien-Dindo complication classification		30 days
Secondary	Length of stay		30 days