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Clinical Trials/NCT05544487
NCT05544487
Not yet recruiting
Not Applicable

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

National and Kapodistrian University of Athens0 sites300 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Anastomosis
Sponsor
National and Kapodistrian University of Athens
Enrollment
300
Primary Endpoint
Leakage rate
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
June 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

George Theodoropoulos

Professor of Surgery

National and Kapodistrian University of Athens

Eligibility Criteria

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

Outcomes

Primary Outcomes

Leakage rate

Time Frame: 30 days

Secondary Outcomes

  • 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)

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