EAST-west Colorectal Study

NCT ID: NCT05544487

Last Updated: 2022-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-06-01

Brief Summary

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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

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Conditions

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Colorectal Anastomosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Colorectal Anastomosis

Differences in intra-operative techniques and surgeon grades

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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George Theodoropoulos

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Maximos Frountzas, PhD

Role: CONTACT

+0030 6978880045

Other Identifiers

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EAST-west 2022

Identifier Type: -

Identifier Source: org_study_id

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