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Volume-outcome Relationship in Rectal Cancer Surgery

Volume-outcome Relationship in Rectal Cancer Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04761536
Enrollment
187
Registered
2021-02-21
Start date
2006-01-31
Completion date
2021-01-31
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak Rectum, Rectal Cancer

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).

Interventions

OTHERRectal 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.

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anastomotic leakup to 30 days after dischargerate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated

Secondary

MeasureTime frameDescription
Surgical site infectionup to 30 days after dischargeRate of any complication after rectal resection
Pneumoniaup to 30 days after dischargerate of radiologically demonstrated pneumonia
Ileusup to 30 days after dischargerate of any ileus clinically demonstrated
Bleedingup to 30 days after dischargeRate of any clinically radiologically or endoscopically demonstrated bleeding after rectal resection
Reoperationup to 30 days after dischargeRate of any reoperation
Readmissionup to 90 days after dischargeRate of any unplanned readmission after discharge
Postoperative complicationsup to 30 days after dischargerate of any surgical site infection clinically demonstrated
1-year stoma persistenceup to one year after surgeryrate of stoma persistence
Length of hospital stayup to 30 days after dischargenumber of days between primary rectal resection and discharge
Use of minimally invasive approachup to 30 days after dischargerate of minimally invasive rectal ARR performed
Operative timeup to 30 days after dischargeMean operative time
Conversion to open surgeryup to 30 days after dischargerate of conversion form laparoscopy to one surgery
need of postoperative blood transfusionup to 30 days after dischargerate of postoperative transfusion
30-days-mortalityup to 30 days after dischargeRate of any mortality

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026