An interventional study of Intracorporeal anastomosis and Extracorporeal anastomosis in Colon Cancer, Colon Neoplasm and Malignant Neoplasm, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-31.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment
Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA).
However, there is currently no randomized studies describing long-term clinical and oncological outcomes.
Background:
Little evidence has been published demonstrating the advantages of IA versus EA.
Recent publications show the superiority of IA in terms of early functional digestive recovery, a shorter surgical incision, a lower need for analgesia, lower blood loss, and lower postoperative Clavien-Dindo grade. These results are similar to other further published studies, including multicenter randomized clinical trials and meta-analyses.
Methods:
This is a a long-term clinical follow-up study of 140 patients included preaviously in the single-blind single-center randomized prospective clinical trial conducted at the Hospital de la Santa Creu i Sant Pau (HSCSP) between 2015-2018; in which 30-day clinical outcomes after laparoscopic right colectomy for colon cancer with IA vs EA anastomosis were compared.
In this new trial, prospective clinical follow-up of the included 140 patients, randomized in two groups IA and EA, will be carried out, with a minimum time of 3 years.
The main objective of the study will be:
-Comparing long-term oncological outcomes of IA vs. EA anastomosis in laparoscopic right colectomy for malignant neoplasm.
The secondary objectives will be:
The main hypothesis will be:
-IA is not inferior compared to EA in terms of oncological and clinical results, with a lower rate of abdominal postoperative hernias and occlusive/subocclusive episodes.
A regular prospective clinical follow-up through periodic medical visits and complementary tests established by the criteria of the Colorectal Cancer management protocol (document agreed by the HSCSP Colorectal Tumors Committee) will be conducted.
For the economic evaluation, all direct in-hospital costs that were registered by the HSCSP management will be analysed.
Extensive written information and an informed consent about the study will be provided to the patient.
The study does not entail any risk for the patient as it does not interfere with the usual follow-up or require extraordinary complementary studies.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 140 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental: Intracorporeal anastomosis Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen is retrieved through a Pfannenstiel incision.
Procedure: Intracorporeal anastomosis
A transverse incision in the right upper quadrant is performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler
Procedure: Extracorporeal anastomosis
Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision. Device: Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.
A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler. Device: Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.
Overall survival
Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed
Time frame: 3 years
Disease-free survival
Percentage of patients alive without any type of recurrence (local or distant) after a 3-years follow-up-period since the laparoscopic right colectomy is performed
Time frame: 3 years
Local recurrence
Percentage of patients that experiment disease recurrence which is placed in the previously operated area
Time frame: 3 years
Distant recurrence
Percentage of patients that experiment disease recurrence which is placed in a different area from the previously operated region (intraperitoneal, liver, lung metastases, etc)
Time frame: 3 years
Incisional hernia
Percentage of patients that present an abdominal hernia settled on any of the incisions performed during the laparoscopic right colectomy
Time frame: 3 years
Intestinal obstruction
Percentage of patients that experiment mechanical impairment or complete arrest of the passage of contents through the intestine due to pathology that causes blockage of the bowel.
Time frame: 3 years
Cost of surgical material
Price (in euro) of the material used in the operating room in each procedure
Time frame: Intraoperative time
Cost of operative room
Price (in euro) of the total amount of hours of surgical time per each procedure
Time frame: Intraoperative time
Cost per global hospitalization
Price (in euro) of the total amount of days of hospitalization per each group
Time frame: Time from the first day of operation until the day that the patient is discharged from the hospital
Cost per ICU hospitalization
Price (in euro) of the total amount of days of hospitalization in Intensive Care Unit per each group
Time frame: Time from the first day of entry into ICU until the day that the patient is transfered to Surgery Department
Cost of tests during hospitalization
Price (in euro) of the total amount of costs related to laboratory and diagnosis during the hospitalization period, per each group
Time frame: Time from the first day of operation until the day that the patient is discharged from the hospital
This study is status unknown, as verified in Oct 2022. 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.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau