CompletedNot Applicable

Volume-outcome Relationship in Rectal Cancer Surgery

187 participantsStarted 2006-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anastomotic leak

Timeframe: up to 30 days after discharge

Trial details

NCT IDNCT04761536

SponsorUniversity of Rome Tor Vergata

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Rectal Cancer trials