Clinical trial NCT04761536: Volume-outcome Relationship in Rectal Cancer Surgery
Official title: Volume-outcome Relationship in Rectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Anastomotic Leak Rectum
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Anastomotic leak
timeFrame: up to 30 days after discharge
Secondary outcomes:
measure: Postoperative complications
timeFrame: up to 30 days after discharge
measure: Surgical site infection
timeFrame: up to 30 days after discharge
measure: Pneumonia
timeFrame: up to 30 days after discharge
measure: Ileus
timeFrame: up to 30 days after discharge
measure: Bleeding
timeFrame: up to 30 days after discharge
measure: Reoperation
timeFrame: up to 30 days after discharge
measure: Readmission
timeFrame: up to 90 days after discharge
measure: 30-days-mortality
timeFrame: up to 30 days after discharge
measure: 1-year stoma persistence
timeFrame: up to one year after surgery
measure: Length of hospital stay
timeFrame: up to 30 days after discharge
measure: Use of minimally invasive approach
timeFrame: up to 30 days after discharge
measure: Operative time
timeFrame: up to 30 days after discharge
measure: Conversion to open surgery
timeFrame: up to 30 days after discharge
measure: need of postoperative blood transfusion
timeFrame: up to 30 days after discharge
Other outcomes:
Locations:
Study officials:
References: