Volume-outcome Relationship in Rectal Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2021-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Rectal Cancer Anastomotic Leak Rectum

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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A

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

Rectal cancer case centralization

Intervention Type 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.

B

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

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No