An observational study in Rectal Neoplasms, sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Observational
Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.
Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's planned enrollment of 333 is above the median of 156 across 421 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021
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:
Patients diagnosed with rectal neoplasia undergoing elective surgery between 2017 and 2021 at medical centers within the national territory.
Other: Data collection
Collection of preoperative demographic, clinical, and radiological variables from patients who meet the inclusion criteria in order to identify possible risk factors for suboptimal surgical treatment
Suboptimal oncological outcomes
Surgical resection with affected margins (proximal-distal and/or circumferential \< 1mm) and/or incomplete or nearly complete mesorectal resection
Time frame: 15 postoperative days
Surgical and Postoperative complications
Conversion to open surgery and anastomotic dehiscence rates
Time frame: 30 postoperative days
Overall and disease free survival
Recurrence of the tumoral disease at the pelvic level and distant recurrence is defined as s the recurrence of the disease in other distant organs.
Time frame: 3-years surgery
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Apr 2025, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta