Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracorporeal anastomosis (IA) | Experimental | 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. |
|
| Extracorporeal anastomosis (EA) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracorporeal anastomosis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Local recurrence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Sánchez López | Contact | +34686274695 | asanchezlope@santpau.cat |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30191370 | Background | Bollo J, Salas P, Martinez MC, Hernandez P, Rabal A, Carrillo E, Targarona E. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial. Int J Colorectal Dis. 2018 Nov;33(11):1635-1641. doi: 10.1007/s00384-018-3157-9. Epub 2018 Sep 6. | |
| 31846067 |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 26, 2023 | |
| Reset | Mar 29, 2024 |
Not provided
The study was a parallel group trial with a 1:1 allocation ratio.
Not provided
Not provided
Not provided
|
| Extracorporeal anastomosis | Procedure | 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. |
|
Percentage of patients that experiment disease recurrence which is placed in the previously operated area
| 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) | 3 years |
| Incisional hernia | Percentage of patients that present an abdominal hernia settled on any of the incisions performed during the laparoscopic right colectomy | 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. | 3 years |
| Cost of surgical material | Price (in euro) of the material used in the operating room in each procedure | Intraoperative time |
| Cost of operative room | Price (in euro) of the total amount of hours of surgical time per each procedure | Intraoperative time |
| Cost per global hospitalization | Price (in euro) of the total amount of days of hospitalization per each group | 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 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 from the first day of operation until the day that the patient is discharged from the hospital |
| Bollo J, Turrado V, Rabal A, Carrillo E, Gich I, Martinez MC, Hernandez P, Targarona E. Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial). Br J Surg. 2020 Mar;107(4):364-372. doi: 10.1002/bjs.11389. Epub 2019 Dec 17. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2023 | Mar 29, 2024 |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided