Clinical trial NCT05544487: EAST-west Colorectal Study
Official title: The Effect of Preoperative Factors and Surgical Technique on Postoperative Outcomes in Patients Undergoing Colorectal Resections at South-eastern Europe.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Anastomosis
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 300
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing colorectal anastomoses due to benign or malignant reasons.

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.


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

Primary outcomes:
measure: Leakage rate
timeFrame: 30 days
Secondary outcomes:
measure: Re-admission rate within the first 30 days post-surgery.
timeFrame: 30 days
measure: 30-day postoperative morbidity
timeFrame: 30 days
measure: 30-day postoperative mortality
timeFrame: 30 days
measure: Clavien-Dindo complication classification
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: