Volume-outcome Relationship in Rectal Cancer Surgery

University of Rome Tor Vergata

Status: Completed

Conditions: Anastomotic Leak Rectum; Rectal Cancer

Treatments: Other: Rectal cancer case centralization

Study type: Observational

Funder types: Other

Identifiers

NCT04761536

REGISTROSPERIMENTAZIONI XX/21

Details and patient eligibility

About

Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of a cancer located in the rectum, defined according to the international definition by D'Souza et al.,
• elective setting
• anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy).

Exclusion criteria

• age below age of 18,
• inflammatory bowel disease,
• acquired or congenital immunodeficiency,
• preoperative infection,
• pregnancy,
• ASA IV,
• presence of synchronous cancers,
• abdominoperineal resection (APR),
• failure to perform rectal resection and primary anastomosis,
• emergency setting.

Trial design

187 participants in 2 patient groups

A

Description:

patients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases

Treatment:

Other: Rectal cancer case centralization

B

Description:

patients undergoing ARR with primary anastomosis between January 2006 and October 2016