Volume-outcome Relationship in Rectal Cancer Surgery

February 15, 2021 updated by: Giuseppe Sigismondo Sica, University of Rome Tor Vergata
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
A
patients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases
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.
B
patients undergoing ARR with primary anastomosis between January 2006 and October 2016

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anastomotic leak
Time Frame: up to 30 days after discharge
rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated
up to 30 days after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Readmission
Time Frame: up to 90 days after discharge
Rate of any unplanned readmission after discharge
up to 90 days after discharge
Pneumonia
Time Frame: up to 30 days after discharge
rate of radiologically demonstrated pneumonia
up to 30 days after discharge
Ileus
Time Frame: up to 30 days after discharge
rate of any ileus clinically demonstrated
up to 30 days after discharge
Postoperative complications
Time Frame: up to 30 days after discharge
rate of any surgical site infection clinically demonstrated
up to 30 days after discharge
Surgical site infection
Time Frame: up to 30 days after discharge
Rate of any complication after rectal resection
up to 30 days after discharge
Bleeding
Time Frame: up to 30 days after discharge
Rate of any clinically radiologically or endoscopically demonstrated bleeding after rectal resection
up to 30 days after discharge
Reoperation
Time Frame: up to 30 days after discharge
Rate of any reoperation
up to 30 days after discharge
30-days-mortality
Time Frame: up to 30 days after discharge
Rate of any mortality
up to 30 days after discharge
1-year stoma persistence
Time Frame: up to one year after surgery
rate of stoma persistence
up to one year after surgery
Length of hospital stay
Time Frame: up to 30 days after discharge
number of days between primary rectal resection and discharge
up to 30 days after discharge
Use of minimally invasive approach
Time Frame: up to 30 days after discharge
rate of minimally invasive rectal ARR performed
up to 30 days after discharge
Operative time
Time Frame: up to 30 days after discharge
Mean operative time
up to 30 days after discharge
Conversion to open surgery
Time Frame: up to 30 days after discharge
rate of conversion form laparoscopy to one surgery
up to 30 days after discharge
need of postoperative blood transfusion
Time Frame: up to 30 days after discharge
rate of postoperative transfusion
up to 30 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rome Tor Vergata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REGISTROSPERIMENTAZIONI XX/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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