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NCT Number: NCT04761536

Volume-outcome Relationship in Rectal Cancer Surgery

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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Key information

Conditions

Rectal Cancer Anastomotic Leak Rectum Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rectal cancer case centralization

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.

Primary outcomes

  1. Anastomotic leak

    Time frame: up to 30 days after discharge

    rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated

Secondary outcomes

  1. Postoperative complications

    Time frame: up to 30 days after discharge

    rate of any surgical site infection clinically demonstrated

  2. Surgical site infection

    Time frame: up to 30 days after discharge

    Rate of any complication after rectal resection

  3. Pneumonia

    Time frame: up to 30 days after discharge

    rate of radiologically demonstrated pneumonia

  4. Ileus

    Time frame: up to 30 days after discharge

    rate of any ileus clinically demonstrated

  5. Bleeding

    Time frame: up to 30 days after discharge

    Rate of any clinically radiologically or endoscopically demonstrated bleeding after rectal resection

  6. Reoperation

    Time frame: up to 30 days after discharge

    Rate of any reoperation

  7. Readmission

    Time frame: up to 90 days after discharge

    Rate of any unplanned readmission after discharge

  8. 30-days-mortality

    Time frame: up to 30 days after discharge

    Rate of any mortality

  9. 1-year stoma persistence

    Time frame: up to one year after surgery

    rate of stoma persistence

  10. Length of hospital stay

    Time frame: up to 30 days after discharge

    number of days between primary rectal resection and discharge

  11. Use of minimally invasive approach

    Time frame: up to 30 days after discharge

    rate of minimally invasive rectal ARR performed

  12. Operative time

    Time frame: up to 30 days after discharge

    Mean operative time

  13. Conversion to open surgery

    Time frame: up to 30 days after discharge

    rate of conversion form laparoscopy to one surgery

  14. need of postoperative blood transfusion

    Time frame: up to 30 days after discharge

    rate of postoperative transfusion

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Important dates

Study start
2006
Primary completion
2020
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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