Roux-en-y Anastomosis SiteNCT05746936
Robotic Versus Laparoscopic Roux En-y Gastric Bypass
An observational study of Roux-en-y Anastomosis Site and Obesity, Morbid, run by University of Foggia at 1 site in Italy.
Trial summary
This study retrospectively identified 33 consecutive obese patients who underwent either laparoscopic or robotic gastric bypass procedures over a 2-year period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Roux-en-y Anastomosis Site, Obesity, Morbid, Bypass Complication
- What is being tested?
- Roux en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 15 Jan 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized psychological and physical evaluation which includes blood chemistry tests, chest x-rays, electrocardiogram and cardiological examinations, nutritional evaluation, esophagogastroduodenoscopy, spirometry and psychiatric evaluation .
Who may be able to join
- Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity
- BMI≥40kg/m2, age ≥ 18 years.
Who cannot join
- Re-do surgery procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Robotic Gastric Bypass be Considered a Valid Alternative to Laparoscopy: Our Early Experience
This study retrospectively identified 33 consecutive obese patients who underwent either laparoscopic or robotic gastric bypass procedures over a 2-year period.
- Conditions
- Roux-en-y Anastomosis Site, Obesity, Morbid, Bypass Complication, Anastomosis; Complications, Surgery-Complications
- Being tested
- Roux en-Y gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux en-Y gastric bypassProcedure or surgery
gastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Obese patients underwent laparoscopic gastric bypass | Not described Receives: Procedure: Roux en-Y gastric bypass | |
| obese patients underwent robotic gastric bypass | Not described Receives: Procedure: Roux en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences between the robotic and laparoscopic gastric bypass
incidence of mortality and morbidity (percentage)
Measured: two years period
differences between the robotic and laparoscopic gastric bypass
BMI ( kg/m2)
Measured: two years period
differences between the robotic and laparoscopic gastric bypass
age (years)
Measured: two years period
differences between the robotic and laparoscopic gastric bypass
weight (kg)
Measured: two years period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Roux-en-y Anastomosis SiteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanna Pavone, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746936
- Sponsor's protocol ID
- 7
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavone G, Pacilli M, Gerundo A, Quazzico A, Ambrosi A, Tartaglia N. Can robotic gastric bypass be considered a valid alternative to laparoscopy? Our early experience and literature review. Front Surg. 2024 Feb 5;11:1303351. doi: 10.3389/fsurg.2024.1303351. eCollection 2024.
PubMed 38375411
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Robotic Gastric Bypass be Considered a Valid Alternative to Laparoscopy: Our Early Experience
- ClinicalTrials.gov ID
- NCT05746936
- Acronym / sponsor ID
- 7
- Conditions
- Roux-en-y Anastomosis Site, Obesity, Morbid, Bypass Complication, Anastomosis; Complications, Surgery-Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 28 Feb 2023 (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.
This study retrospectively identified 33 consecutive obese patients who underwent either laparoscopic or robotic gastric bypass procedures over a 2-year period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients underwent laparoscopic gastric bypass | – | Procedure: Roux en-Y gastric bypass |
| obese patients underwent robotic gastric bypass | – | Procedure: Roux en-Y gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized psychological and physical evaluation which includes blood chemistry tests, chest x-rays, electrocardiogram and cardiological examinations, nutritional evaluation, esophagogastroduodenoscopy, spirometry and psychiatric evaluation .
Key inclusion criteria (2 listed)
- Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity
- BMI≥40kg/m2, age ≥ 18 years.
Key exclusion criteria (1 listed)
- Re-do surgery procedures
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 |
|---|---|---|
| Roux en-Y gastric bypassgastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis | Procedure or surgery | Obese patients underwent laparoscopic gastric bypass, obese patients underwent robotic gastric bypass |
Primary outcome
differences between the robotic and laparoscopic gastric bypass
Time frame: two years period
incidence of mortality and morbidity (percentage)
differences between the robotic and laparoscopic gastric bypass
Time frame: two years period
BMI ( kg/m2)
differences between the robotic and laparoscopic gastric bypass
Time frame: two years period
age (years)
differences between the robotic and laparoscopic gastric bypass
Time frame: two years period
weight (kg)
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 28 Feb 2023.
- Derived from this study: PubMed 38375411Pavone G, Pacilli M, Gerundo A, Quazzico A, Ambrosi A, Tartaglia N. Can robotic gastric bypass be considered a valid alternative to laparoscopy? Our early experience and literature review. Front Surg. 2024 Feb 5;11:1303351. doi: 10.3389/fsurg.2024.1303351. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Roux-en-y Anastomosis Site and Obesity, Morbid, run by University of Foggia at 1 site in Italy.
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 2 inclusion and 1 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
differences between the robotic and laparoscopic gastric bypass (time frame: two years period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746936, which also lists 1 linked publication.
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 28 Feb 2023.