Right HemicolectomyNCT04578405
Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Right Hemicolectomy, run by Jagiellonian University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Hemicolectomy
- What is being tested?
- Intracorporeal anastomosis and Extracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- malignant or benign neoplasm located in right side of the colon
Who cannot join
- stage IV disease
- conversion
- inflammatory bowel diseases
- corticosteroid intake
- immunodeficiency
- emergency surgery
- neoadjuvant therapy
- no technical possibility to perform either anastomosis
About this study
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.
- Conditions
- Right Hemicolectomy
- Being tested
- Intracorporeal anastomosis, Extracorporeal anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal anastomosisProcedure or surgery
Anastomosis performed totally laparoscopically
Extracorporeal anastomosisProcedure or surgery
Anastomosis performed through a minilaparotomy
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal anastomosis | Active comparator | Not described Receives: Procedure: Extracorporeal anastomosis |
| Intracorporeal anastomosis | Experimental | Not described Receives: Procedure: Intracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first stool
Measured: 5 days
Secondary outcomes (4)
Time to first flatus
Measured: 5 days
Complications
Measured: 30 day
Length of surgery
Measured: 1 day
Length of hospital stay
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Aug 2016
- Primary completion1 Apr 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right HemicolectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Pędziwiatr, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578405
- Sponsor's protocol ID
- JagiellonianU-6
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04578405
- Acronym / sponsor ID
- JagiellonianU-6
- Conditions
- Right Hemicolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal anastomosis | Active comparator | Procedure: Extracorporeal anastomosis |
| Intracorporeal anastomosis | Experimental | Procedure: Intracorporeal anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- malignant or benign neoplasm located in right side of the colon
Key exclusion criteria (8 listed)
- stage IV disease
- conversion
- inflammatory bowel diseases
- corticosteroid intake
- immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracorporeal anastomosisAnastomosis performed totally laparoscopically | Procedure or surgery | Intracorporeal anastomosis |
| Extracorporeal anastomosisAnastomosis performed through a minilaparotomy | Procedure or surgery | Extracorporeal anastomosis |
Primary outcome
Time to first stool
Time frame: 5 days
4 secondary outcomes
Time to first flatus
Time frame: 5 days
Complications
Time frame: 30 day
Length of surgery
Time frame: 1 day
Length of hospital stay
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Right Hemicolectomy
RecruitingObservational study
Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System
Right Colectomy
Not yet recruitingObservational study
Multicenter Prospective Study Protocol for Validating Surgical Quality Standards in D3 Lymphadenectomy for Oncological Right Hemicolectomy
Colon Neoplasms, Right Colon Tumors
Not yet recruitingObservational study
Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis
Right Colon Cancer
RecruitingObservational study
Chronic Loose Stools Following Right-sided Hemicolectomy for Colon Cancer and the Association With Bile Acid Malabsorption and Small Intestinal Bacterial Overgrowth Using a Novel Sampling Device
Colon Cancer
RecruitingObservational study
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
Anastomotic Leak, Colon Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Right Hemicolectomy, run by Jagiellonian University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first stool (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.