Volume-outcome Relationship in Rectal Cancer Surgery

Rectal Cancer Clinical Trial

Official title:

Volume-outcome Relationship in Rectal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761536
• Other study ID #: REGISTROSPERIMENTAZIONI XX/21
• Status: Completed
• Start date: January 2006
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: January 31, 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Rectum
• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Outcome

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