Volume-outcome Relationship in Rectal Cancer Surgery

Completed

• Conditions: Rectal Cancer; Anastomotic Leak Rectum
• Interventions: Other: Rectal cancer case centralization

• Registration Number: NCT04761536
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2020-12
• Study Completion: 2021-01-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Rectal cancer case centralization	patients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases

Primary Outcome Measures

Name	Time	Method
Anastomotic leak	up to 30 days after discharge	rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated

Secondary Outcome Measures

Name	Time	Method
Ileus	up to 30 days after discharge	rate of any ileus clinically demonstrated
Bleeding	up to 30 days after discharge	Rate of any clinically radiologically or endoscopically demonstrated bleeding after rectal resection
Readmission	up to 90 days after discharge	Rate of any unplanned readmission after discharge
1-year stoma persistence	up to one year after surgery	rate of stoma persistence
Use of minimally invasive approach	up to 30 days after discharge	rate of minimally invasive rectal ARR performed
Surgical site infection	up to 30 days after discharge	Rate of any complication after rectal resection
Conversion to open surgery	up to 30 days after discharge	rate of conversion form laparoscopy to one surgery
need of postoperative blood transfusion	up to 30 days after discharge	rate of postoperative transfusion
Postoperative complications	up to 30 days after discharge	rate of any surgical site infection clinically demonstrated
Pneumonia	up to 30 days after discharge	rate of radiologically demonstrated pneumonia
Reoperation	up to 30 days after discharge	Rate of any reoperation
30-days-mortality	up to 30 days after discharge	Rate of any mortality
Length of hospital stay	up to 30 days after discharge	number of days between primary rectal resection and discharge
Operative time	up to 30 days after discharge	Mean operative time