An observational study in Anastomotic Leak Large Intestine and Right Colon Tumors, sponsored by San Luigi Gonzaga Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by San Luigi Gonzaga Hospital · Observational
This is a nationwide prospective observational study to assess the overall clinical anastomotic leakage rate after right hemicolectomy for cancer, to detect the independent risk factors for AL, and to develop a clinical prediction model to estimates of the probability of the occurrence of an AL after surgery. Since this is a multicenter prospective study, the Division of Surgical Oncology and Digestive Surgery from the University of Turin, Department of Oncology, AOU San Luigi Gonzaga di Orbassano will be the Coordinator Center of the study, Ethics committee approves will be requested before the implementation of this study.
Italian high-volume colorectal surgery centers members of SICO (The Italian Society of Oncological Surgery) have agreed to participate as collaborators of this study, notification and revision from their local ethics committee will be requested as well. A certified general surgeon with a large experience in the preoperative, operative, and postoperative management of patients with colorectal cancer has been identified to coordinate the study in each center. Id information of the potential collaborators is specified in the section "Trial Setting". Once the study is activated, eligible patients (or a representative) must provide written, informed consent before any study procedures occur. No intervention or modification of the habitual clinical practice is planned All data will enter into a database provided by the promoting center. There are three main sections of data collection for each patient:
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's planned enrollment of 1,839 is above the median of 166 across 111 observational studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →San Luigi Gonzaga Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients from all participating centers older than 18 years, males or females, with the diagnosis of primary right colon cancer including the cecum, ascendent, liver flexure, and proximal third of the transverse colon, in both emergency and elective settings, with the indication of RH, referred as to the resection of a portion of the distal ileum, cecum, ascending colon, and proximal to the mid-transverse colon, with intraperitoneal or extraperitoneal primary handsewn or mechanical ileocolic anastomosis by minimally invasive(robotic or laparoscopic) or open approach.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
overall rate of AL
defined as the total cases of patients with clinical signs or symptoms of AL (pain, fever, tachycardia, peritonitis, feculent or enteric drainage, purulent drainage, postoperative ileus, abscess, septicemia, and/or organ failure), any radiological findings suggestive of AL (fluid collections, gas containing collections at CT scan) or intraoperative or autopsy findings (gross enteric spillage, anastomotic disruption), expressed in percentage. \[time frame: from 1st to 30th postoperative day\]. And identify the main associated factors through a multivariate model regression.
Time frame: from 1st to 30th postoperative day
overall morbidity
The rate of overall morbidity in patients with and without AL. Refers to adverse events and complications following surgery and classified by Clavien Dindo score
Time frame: from 1st to 60 postoperative day
operative mortality
The rate of operative mortality in patients with and without AL. Operative mortality was defined as death that occurred within 30 days after the primary operation
Time frame: within 30 postoperative days
Length of stay.
Total Length of stay. Defined as the length of an inpatient episode of care, calculated from the surgery day to the day of discharge and based on the number of nights spent in the hospital. Adding all the admissions episodes related and no related to AL
Time frame: from date of surgery up to 200 days
reoperation
The rate of reoperation in patients with and without AL: defined of the total cases of patients submitted to secondary surgery for any direct untoward effect of the right colon resection
Time frame: from 1st to 60 postoperative day
Plan to share: Yes
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Jun 2025, 53 months after the start.
Of 50 non-industry observational studies under Anastomotic Leak, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 73. This study's planned 53 months is above that.
Counting every sponsor, half of 52 studies reached it within 33 months; a quarter within 23 and three quarters within 98.
How these figures are worked out, and which studies are left out of them.
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San Luigi Gonzaga Hospital