Surgical Treatment of ObesityMINIOBNCT02360176
Benefit of Single Port-surgery in Sleeve Gastrectomy
A study testing Sleeve gastrectomy single port and Sleeve gastrectomy multi trocar in people with Surgical Treatment of Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgical Treatment of Obesity
- What is being tested?
- Sleeve gastrectomy single port and Sleeve gastrectomy multi trocar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2017to Jan 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI> 35 kg/m2 with comorbidity (s) or> 40 kg/m2
- Patients aged 18 to 65 years
- Discussion and decision sleeve gastrectomy multidisciplinary meeting
- Free, informed and written consent
- Affiliation to a social security or other assurance
Who cannot join
- Uncontrolled severe infection
- Liver disease other than obesity pathology
- Pregnancy (positive hCG)
- Large hiatal hernia
- Esophagitis uncontrolled
- History of gastric bypass and gastric surgery other than gastric banding
Show all 11Show fewer
- Saving Justice guardianship
- Participation in another ongoing study
- Cognitive or severe mental illness
- Severe and non-stabilized eating disorders
- Addiction to alcohol and psychoactive substances"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Minimally Invasive Bariatric Surgery Using a Single Laparoscopic Trocar (Single Incision of 2.5 to 3 cm) Versus 4 to 7 Trocars in Sleeve Gastrectomy
Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality
Read the detailed description
The single port surgery is the natural evolution of laparoscopy. To date only few studies have evaluated the feasibility of this technique in sleeve gastrectomy. The investigators want to demonstrate the non-inferiority in terms of morbidity-mortality of use single trocar in sleeve gastrectomy compared the multiport technique. Moreover it should highlight the non-inferiority in terms of anatomical quality, reduction of excess weight lost, reduction of comorbidities, decrease post operative pain, improved quality of life and evaluate medico-economic impact of these technique to validating this new surgical approach for bariatric surgery. The study will be multicentric with 6 university center (Montpellier, Amiens, Lille, Creteil, Poissy and Montsouris Institut). 388 patients will be included in the tow group of the prospective randomise study.
- Conditions
- Surgical Treatment of Obesity
- Being tested
- Sleeve gastrectomy single port, Sleeve gastrectomy multi trocar
- Keywords
- single port surgery, bariatric surgery, sleeve gastrectomy, randomise prospective study, complication rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomy single portProcedure or surgery
Bariatric surgery: one incision of 2.5 to 3 cm
Sleeve gastrectomy multi trocarProcedure or surgery
Bariatric surgery: 4 to 7 incisions of 1 to 2 cm
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy single port | Experimental | Sleeve gastrectomy single port Receives: Procedure: Sleeve gastrectomy single port |
| Sleeve gastrectomy multi trocar | Active comparator | Sleeve gastrectomy multi trocar Receives: Procedure: Sleeve gastrectomy multi trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
The principal criteria of analysis will be a score of morbidity and mortality at 24 months including: rate of fistula and intra-abdominal abscesses, the bleeding rate, the rate of gastric stenosis, rate splenic lesions, residual pouch or parietal damage (abscesses, incisional hernia, hematoma, delayed wound healing), and death
Measured: up to 24 months
Secondary outcomes (2)
Complication rate
Measured: up 3, 6, 9, and 12 months
Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively
Measured: up 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start4 Jan 2017
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Treatment of ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Pourcher, MD PhD, Principal investigator, Montsouris Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360176
- Sponsor's protocol ID
- P130940
- Acronym
- MINIOB
- Status last verified
- Sep 2020
- First submitted
- 5 Feb 2015
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Minimally Invasive Bariatric Surgery Using a Single Laparoscopic Trocar (Single Incision of 2.5 to 3 cm) Versus 4 to 7 Trocars in Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02360176
- Acronym / sponsor ID
- MINIOB / P130940
- Conditions
- Surgical Treatment of Obesity
- Keywords
- single port surgery, bariatric surgery, sleeve gastrectomy, randomise prospective study, complication rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 10 Feb 2015 (estimated)
- 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.
Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality
Detailed description
The single port surgery is the natural evolution of laparoscopy. To date only few studies have evaluated the feasibility of this technique in sleeve gastrectomy. The investigators want to demonstrate the non-inferiority in terms of morbidity-mortality of use single trocar in sleeve gastrectomy compared the multiport technique. Moreover it should highlight the non-inferiority in terms of anatomical quality, reduction of excess weight lost, reduction of comorbidities, decrease post operative pain, improved quality of life and evaluate medico-economic impact of these technique to validating this new surgical approach for bariatric surgery. The study will be multicentric with 6 university center (Montpellier, Amiens, Lille, Creteil, Poissy and Montsouris Institut). 388 patients will be included in the tow group of the prospective randomise study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy single port | Experimental | Procedure: Sleeve gastrectomy single portSleeve gastrectomy single port |
| Sleeve gastrectomy multi trocar | Active comparator | Procedure: Sleeve gastrectomy multi trocarSleeve gastrectomy multi trocar |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI> 35 kg/m2 with comorbidity (s) or> 40 kg/m2
- Patients aged 18 to 65 years
- Discussion and decision sleeve gastrectomy multidisciplinary meeting
- Free, informed and written consent
- Affiliation to a social security or other assurance
Key exclusion criteria (11 listed)
- Uncontrolled severe infection
- Liver disease other than obesity pathology
- Pregnancy (positive hCG)
- Large hiatal hernia
- Esophagitis uncontrolled
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 |
|---|---|---|
| Sleeve gastrectomy single portBariatric surgery: one incision of 2.5 to 3 cm | Procedure or surgery | Sleeve gastrectomy single port |
| Sleeve gastrectomy multi trocarBariatric surgery: 4 to 7 incisions of 1 to 2 cm | Procedure or surgery | Sleeve gastrectomy multi trocar |
Primary outcome
Complication rate
Time frame: up to 24 months
The principal criteria of analysis will be a score of morbidity and mortality at 24 months including: rate of fistula and intra-abdominal abscesses, the bleeding rate, the rate of gastric stenosis, rate splenic lesions, residual pouch or parietal damage (abscesses, incisional hernia, hematoma, delayed wound healing), and death
2 secondary outcomes
Complication rate
Time frame: up 3, 6, 9, and 12 months
Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively
Time frame: up 3, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Surgical Treatment of Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
Changes in Body Composition Following Pharmacological Treatment for Obesity.
Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Impact of Significant Surgical Reduction of Adipose Tissue on Plasma Levels and Genetic Expression of Adipokines Associated With Ischemic Heart Disease in Type I Obesity.
Obesity & Overweight, Obesity Type I and II
RecruitingPhase 4
Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
Obesity
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.
Guillaume Pourcher, MD PhD principal investigator
Montsouris Institut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy single port and Sleeve gastrectomy multi trocar in people with Surgical Treatment of Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. 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 France. 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?
Results are not available in the source record.
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?
Complication rate (time frame: up to 24 months). 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 16 Sep 2020.