Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.
1 other identifier
interventional
110
0 countries
N/A
Brief Summary
Both extracorporeal and intracorporeal anastomosis in laparoscopic right hemicolectomy are renowned and performed worldwide. Many observational studies show conflicting results which method is better. This randomized control trial aimed to assess which technique is superior.
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 Aug 2016
Longer than P75 for not_applicable
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
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedOctober 8, 2020
October 1, 2020
3.7 years
October 2, 2020
October 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first stool
5 days
Secondary Outcomes (4)
Time to first flatus
5 days
Complications
30 day
Length of surgery
1 day
Length of hospital stay
30 day
Study Arms (2)
Extracorporeal anastomosis
ACTIVE COMPARATORIntracorporeal anastomosis
EXPERIMENTALInterventions
Anastomosis performed totally laparoscopically
Anastomosis performed through a minilaparotomy
Eligibility Criteria
You may qualify if:
- malignant or benign neoplasm located in right side of the colon
You may not qualify if:
- stage IV disease
- conversion
- inflammatory bowel diseases
- corticosteroid intake
- immunodeficiency
- emergency surgery
- neoadjuvant therapy
- no technical possibility to perform either anastomosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 2, 2020
First Posted
October 8, 2020
Study Start
August 1, 2016
Primary Completion
April 1, 2020
Study Completion
July 1, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share