Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
1 other identifier
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2022
CompletedFirst Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedOctober 31, 2022
October 1, 2022
10 months
May 23, 2022
October 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed
3 years
Secondary Outcomes (10)
Disease-free survival
3 years
Local recurrence
3 years
Distant recurrence
3 years
Incisional hernia
3 years
Intestinal obstruction
3 years
- +5 more secondary outcomes
Study Arms (2)
Intracorporeal anastomosis (IA)
EXPERIMENTALExperimental: 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 COMPARATORA 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Neoplasms settled in the cecum, right colon, hepatic flexure or proximal transverse colon
- Surgical procedure with curative purpose.
- American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
- Elective surgery.
- Signed Informed Consent.
You may not qualify if:
- Denial of informed consent.
- Advanced neoplasia (Stage IV)
- Urgent surgery.
- ASA IV.
- Bening colonic disease, such Ulcerative Colitis or Crohn Disease
- Multivisceral procedures performed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Related Publications (2)
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.
PMID: 30191370BACKGROUNDBollo 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.
PMID: 31846067BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2022
First Posted
July 6, 2022
Study Start
February 28, 2022
Primary Completion
December 28, 2022
Study Completion
January 1, 2023
Last Updated
October 31, 2022
Record last verified: 2022-10