Volume-outcome Relationship in Rectal Cancer Surgery

NCT04761536 | Completed

• 1 other identifier: REGISTROSPERIMENTAZIONI XX/21
• Study Type: observational
• Target: 187
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Rectal Cancer; Anastomotic Leak Rectum

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak

  rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated

  up to 30 days after discharge

Secondary Outcomes (14)

• Postoperative complications

  up to 30 days after discharge

• Surgical site infection

  up to 30 days after discharge

• Pneumonia

  up to 30 days after discharge

• Ileus

  up to 30 days after discharge

• Bleeding

  up to 30 days after discharge

Study Arms (2)

A

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

Other: Rectal cancer case centralization

B

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

Interventions

Rectal cancer case centralization OTHER

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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2006
• Primary Completion: December 1, 2020
• Study Completion: January 31, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02