EAST-west Colorectal Study

Sponsor
National and Kapodistrian University of Athens (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05544487
Collaborator
(none)
300
8

Study Details

Study Description

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 (Greece, Romania and Malta). This would enable variabilities in practice to be identified and differences regarding postoperative outcomes to be highlighted.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Colorectal Anastomosis

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Effect of Preoperative Factors and Surgical Technique on Postoperative Outcomes in Patients Undergoing Colorectal Resections at South-eastern Europe.
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Leakage rate [30 days]

Secondary Outcome Measures

  1. Re-admission rate within the first 30 days post-surgery. [30 days]

  2. 30-day postoperative morbidity [30 days]

  3. 30-day postoperative mortality [30 days]

  4. Clavien-Dindo complication classification [30 days]

  5. Length of stay [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National and Kapodistrian University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
George Theodoropoulos, Professor of Surgery, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT05544487
Other Study ID Numbers:
  • EAST-west 2022
First Posted:
Sep 16, 2022
Last Update Posted:
Sep 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 16, 2022