Volume-outcome Relationship in Rectal Cancer Surgery

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).

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Anastomotic Leak Rectum
• Intervention / Treatment: Other: Rectal cancer case centralization

• Study Type: Observational
• Enrollment (Actual): 187

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study involved all consecutive eligible patients undergoing elective restorative anterior rectal resection (ARR) for rectal cancer between November 2016 and December 2020 in our Minimally Invasive Surgery Unit of Tor Vergata University Hospital unit (Group A). Outcomes for Group A were compared with an historical control group, consisting of all consecutive patients undergoing ARR in the same hospital between January 2006 and October 2016 (Group B).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; patients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases	Other: Rectal cancer case centralization; In November 2016, the decision to centralize rectal cancer patients to only one surgical unit was taken, with only two surgeons performing the procedures. Furthermore, a close collaboration with local Gastroenterology Units and General Practiotioners was started in order to increase colorectal cancer case referral to our unit. At the same time, we decided to promote the use of laparoscopy and to implement ERAS protocol in our colorectal surgery practice.
B; patients undergoing ARR with primary anastomosis between January 2006 and October 2016

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anastomotic Leak
• Other Study ID Numbers: REGISTROSPERIMENTAZIONI XX/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No