Selection of Surgical Technique in Rectal Cancer
ConditionRectal Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.
Age ≥ 18 years.
Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.
Initial stage T1-T4a. Any N. Any M.
Disqualifiers
Colorectal tumor with histology different from adenocarcinoma.
Synchronous colon tumor.
Benign pathology or adenoma.
Tis.
Trial population
Patients diagnosed with rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Data collection
Other interventionCollection 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
Treatment groups
333 Participants
are divided into 1 treatment groupGroup A: Patients undergoing elective surgery for rectal neoplasm1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
Surgical and Postoperative complications
Conversion to open surgery and anastomotic dehiscence rates
Time frame
30 postoperative days2
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov