Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy
1 other identifier
interventional
140
1 country
1
Brief Summary
The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic results, analgesia requirements and length of hospital stay. The objective of this study is to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in patients undergoing laparoscopic right hemicolectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started May 2015
Longer than P75 for not_applicable pain
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
May 20, 2015
CompletedFirst Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2018
CompletedJanuary 14, 2019
January 1, 2019
3.1 years
January 13, 2016
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of stay
is identified when the patient has tolerated diet and has had bowel movements and is discharged from the hospital
1 month
Secondary Outcomes (6)
Return to normal peristalsis
1 week
Size of the surgical wound
1 month
Rate of Surgical Site Infection
1 month
Rate of Incisional Hernia
1 year after discharge
Aesthetic result
1 month after discharge
- +1 more secondary outcomes
Study Arms (2)
Intracorporeal anastomosis
EXPERIMENTALIso 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.
Extracorporeal anastomosis
ACTIVE COMPARATORA 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 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.
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.
Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.
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:
- Surgical procedure with curative purpose.
- American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
- Elective surgery.
- Informed consent.
You may not qualify if:
- Denial of informed consent.
- Advanced neoplasia.
- Urgent surgery.
- ASA IV.
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, 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: 31846067DERIVEDBollo 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: 30191370DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus Bollo
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
January 13, 2016
First Posted
January 29, 2016
Study Start
May 20, 2015
Primary Completion
June 21, 2018
Study Completion
July 21, 2018
Last Updated
January 14, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- All the time
- Access Criteria
- without
Raw data will be available upon request to the main researcher.