Obesity & OverweightSCANOBENCT07296224
Scannographic Predictive Factors of Change of Strategy During Metabolic Bariatric Surgery
An observational study of Obesity & Overweight, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Background: Laparoscopic Roux-en-Y Gastric By-pass (LRYGB) is not always feasible due to intraoperative difficulties, necessitating a change during surgical procedure. Non-contrast abdominal CT scans is not recommended before bariatric surgery but could be informative and very few studies have evaluated the relevance… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity & Overweight
- How many people
- 288 participants
- Where
- 1 siteFrance
- Study dates
- 8 May 2023to 20 Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients scheduled for LRYGB surgery at the Nancy University Hospital between 1st October 2012 and 31st December 2022. Patients with body mass index > 35 kg/m2 selected to underwent bariatric surgery by the medical and surgical team Patients with preoperative CT scan
Who may be able to join
- All adult patients scheduled for LRYGB surgery at the Nancy University Hospital between 1st October 2012 and 31st December 2022 who underwent a change in intraoperative surgical strategy
- patient who did not object to the collection of their data.
- patients over the age of 18
Who cannot join
- Patients who did not have a preoperative scan
- patients who were lost to follow-up within 6 months of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scannographic Predictive Factors of Changes in the Intraoperative Therapeutic Strategies During Metabolic Bariatric Surgery (MBS)
Background: Laparoscopic Roux-en-Y Gastric By-pass (LRYGB) is not always feasible due to intraoperative difficulties, necessitating a change during surgical procedure. Non-contrast abdominal CT scans is not recommended before bariatric surgery but could be informative and very few studies have evaluated the relevance of these scans. The primary objective was to identify CT scan criteria that could predict a change in the intraoperative therapeutic strategy during LRYGB. Secondary objectives included identifying clinical data associated with change of intraoperative strategy, the impact of surgeon's experience and evaluate postoperative complications.
Methods: The study was conducted in University Hospital of Nancy, France between October 2012 and December 2022. This retrospective matched-case-control study (1:3) compared patients with intraoperative change of strategy when LRYGB was initially planned (study group) versus matched patients who undergone LRYGB. Clinical, scannographic, surgical experience and postoperative complications data were collected in the two groups.
Read the detailed description
Obesity is a multifactorial condition involving behavioral, environmental and genetic factors . Possible treatments for obesity include nutritional, dietary and cognitive-behavioral management, as well as pharmacological therapies and metabolic bariatric surgery (MBS) . These treatments must be combined and tailored to each patient.
Before the performance of MBS only an esogastroduodenal endoscopy with systematic biopsies for Helicobacter pylori is currently recommended . In France, abdominal ultrasound is added for detecting vesicular lithiasis . According to the American Society for Metabolic and Bariatric Surgery abdominal ultrasound is indicated in patients presenting biliary tract symptoms or liver disease . Non-contrast abdominal CT scan is not an aspect of the initial assessment in Europe or in the United States . To our knowledge, only one MBS team evaluated the value of preoperative CT scans for identifying silent pathologies and concluded that the value of CT scans were minimal . In Nancy University Hospital, a preoperative non-contrast abdominal CT scan is proposed to all patients scheduled for MBS to screen for incidental lesions, hiatal hernia not visible in endoscopy and left liver hypertrophy.
In Nancy University Hospital, a Laparoscopic Roux-en-Y gastric bypass (LRYGB) is preferentially performed. Due to surgical difficulties, LRYGB is not always an option for treatment. In these cases, a change in the surgical procedure may be needed. In very difficult cases, the performance of any MBS may be impossible.
The investigator hypothesizes that preoperative scannographic features-especially increased left liver volume (LLV) -are predictive of intraoperative strategy change during LRYGB, and that this risk is further influenced by patient history and surgeon experience.
Design This was a retrospective, single-center, observational case-control study conducted between 1st October 2012 and 31st December 2022 at the University Hospital of Nancy.
Population All adult patients scheduled for LRYGB surgery at the Nancy University Hospital between 1st October 2012 and 31st December 2022 who underwent a change in intraoperative surgical strategy and who did not object to the collection of their data were identified. Patients who did not have a preoperative scan and those who were lost to follow-up within 6 months of surgery were excluded.
Based on surgical reports, a change in surgical strategy was defined as follows: patients who underwent laparoscopic sleeve gastrectomy, laparotomy Roux-en-Y gastric bypass or laparotomy sleeve gastrectomy instead of a LRYGB and patients who experienced an interruption of the procedure during LRYGB.
Each patient who had undergone a change in strategy was subsequently randomly matched with three 'controls' who were comparable in terms of age (within 5 years of each other), sex and body mass index (BMI). The controls were defined as patients with the same inclusion criteria as those patients in the 'change of strategy' group but who had undergone a LRYGB.
Collected data The clinical data that were collected included age, sex, weight, height, BMI, history of abdominal surgery, hypertension, diabetes, obstructive sleep apnoea syndrome, non-alcoholic fatty liver disease and dyslipidemia. Surgeon's experience reported as junior (≤100 cases of MBS) or senior (>100 cases of MBS), A unique radiologist who was unaware of the patient's details and surgical history analysed preoperative non-contrast abdominal CT scans and used Aw Server version 3.2. The preoperative scan criteria included parietal thickness, the peritoneal height/width ratio in axial section and the visceral perimeter at L1, the umbilical perimeter, the total psoas area (TPA) (mm2) at L3 and the LLV . The measurement of visceral perimeter, umbilical perimeter and total psoas area was performed using manual measurement. The measurement of the LLV was performed using semi-automatic measurement adjusted by the radiologist as necessary.
- Conditions
- Obesity & Overweight
- Keywords
- metabolic bariatric surgery, obesity, gastric bypass, sleeve
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent a change of surgical strategy | patients who underwent an other surgical strategy than gastric by pass : laparoscopic sleeve gastrectomy, sleeve gastrectomy or gastric bypass by laparotomy, no metabolic bariatric surgery (procedure impossible to achieve) | |
| control group | patients who underwent laparoscopic gastric bypass. Each patient who had undergone a change in strategy was subsequently randomly matched with three 'controls' who were comparable in terms of age (within 5 years of each other), sex and body mass index (BMI). The controls were defined as patients with the same inclusion criteria as those patients in the 'change of strategy' group |
What is being measured
The primary outcome is the main question the study is designed to answer.
left liver volume scannographic measure
the Left Liver Volume (LLV) was measured on an abdominal CT scan by a raidologist
Measured: between 1st October 2012 and 31st December 2022
Secondary outcomes (3)
parietal thickness
parietal thickness was measured on abdominal CT scan
Measured: between 1st October 2012 and 31st December 2022
surgical experience, number of bariatric procedure done before the surgery studied (less than 100 procedures or more)
Surgeon's experience reported as junior (≤100 cases of MBS) or senior (>100 cases of MBS)
Measured: between 1st October 2012 and 31st December 2022
Post operative morbidity
Post-operative morbidity was evaluated using Clavien-Dindo classification ,180 days after surgery
Measured: between 1st October 2012 and 30st June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 May 2023
- Primary completion20 Jul 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NOMINE-CRIQUI Claire, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296224
- Sponsor's protocol ID
- FORM-03935
- Acronym
- SCANOBE
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scannographic Predictive Factors of Changes in the Intraoperative Therapeutic Strategies During Metabolic Bariatric Surgery (MBS)
- ClinicalTrials.gov ID
- NCT07296224
- Acronym / sponsor ID
- SCANOBE / FORM-03935
- Conditions
- Obesity & Overweight
- Keywords
- metabolic bariatric surgery, obesity, gastric bypass, sleeve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 22 Dec 2025 (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.
Background: Laparoscopic Roux-en-Y Gastric By-pass (LRYGB) is not always feasible due to intraoperative difficulties, necessitating a change during surgical procedure. Non-contrast abdominal CT scans is not recommended before bariatric surgery but could be informative and very few studies have evaluated the relevance of these scans. The primary objective was to identify CT scan criteria that could predict a change in the intraoperative therapeutic strategy during LRYGB. Secondary objectives included identifying clinical data associated with change of intraoperative strategy, the impact of surgeon's experience and evaluate postoperative complications.
Methods: The study was conducted in University Hospital of Nancy, France between October 2012 and December 2022. This retrospective matched-case-control study (1:3) compared patients with intraoperative change of strategy when LRYGB was initially planned (study group) versus matched patients who undergone LRYGB. Clinical, scannographic, surgical experience and postoperative complications data were collected in the two groups.
Detailed description
Obesity is a multifactorial condition involving behavioral, environmental and genetic factors . Possible treatments for obesity include nutritional, dietary and cognitive-behavioral management, as well as pharmacological therapies and metabolic bariatric surgery (MBS) . These treatments must be combined and tailored to each patient.
Before the performance of MBS only an esogastroduodenal endoscopy with systematic biopsies for Helicobacter pylori is currently recommended . In France, abdominal ultrasound is added for detecting vesicular lithiasis . According to the American Society for Metabolic and Bariatric Surgery abdominal ultrasound is indicated in patients presenting biliary tract symptoms or liver disease . Non-contrast abdominal CT scan is not an aspect of the initial assessment in Europe or in the United States . To our knowledge, only one MBS team evaluated the value of preoperative CT scans for identifying silent pathologies and concluded that the value of CT scans were minimal . In Nancy University Hospital, a preoperative non-contrast abdominal CT scan is proposed to all patients scheduled for MBS to screen for incidental lesions, hiatal hernia not visible in endoscopy and left liver hypertrophy.
In Nancy University Hospital, a Laparoscopic Roux-en-Y gastric bypass (LRYGB) is preferentially performed. Due to surgical difficulties, LRYGB is not always an option for treatment. In these cases, a change in the surgical procedure may be needed. In very difficult cases, the performance of any MBS may be impossible.
The investigator hypothesizes that preoperative scannographic features-especially increased left liver volume (LLV) -are predictive of intraoperative strategy change during LRYGB, and that this risk is further influenced by patient history and surgeon experience.
Design This was a retrospective, single-center, observational case-control study conducted between 1st October 2012 and 31st December 2022 at the University Hospital of Nancy.
Population All adult patients scheduled for LRYGB surgery at the Nancy University Hospital between 1st October 2012 and 31st December 2022 who underwent a change in intraoperative surgical strategy and who did not object to the collection of their data were identified. Patients who did not have a preoperative scan and those who were lost to follow-up within 6 months of surgery were excluded.
Based on surgical reports, a change in surgical strategy was defined as follows: patients who underwent laparoscopic sleeve gastrectomy, laparotomy Roux-en-Y gastric bypass or laparotomy sleeve gastrectomy instead of a LRYGB and patients who experienced an interruption of the procedure during LRYGB.
Each patient who had undergone a change in strategy was subsequently randomly matched with three 'controls' who were comparable in terms of age (within 5 years of each other), sex and body mass index (BMI). The controls were defined as patients with the same inclusion criteria as those patients in the 'change of strategy' group but who had undergone a LRYGB.
Collected data The clinical data that were collected included age, sex, weight, height, BMI, history of abdominal surgery, hypertension, diabetes, obstructive sleep apnoea syndrome, non-alcoholic fatty liver disease and dyslipidemia. Surgeon's experience reported as junior (≤100 cases of MBS) or senior (>100 cases of MBS), A unique radiologist who was unaware of the patient's details and surgical history analysed preoperative non-contrast abdominal CT scans and used Aw Server version 3.2. The preoperative scan criteria included parietal thickness, the peritoneal height/width ratio in axial section and the visceral perimeter at L1, the umbilical perimeter, the total psoas area (TPA) (mm2) at L3 and the LLV . The measurement of visceral perimeter, umbilical perimeter and total psoas area was performed using manual measurement. The measurement of the LLV was performed using semi-automatic measurement adjusted by the radiologist as necessary.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent a change of surgical strategy | – | –patients who underwent an other surgical strategy than gastric by pass : laparoscopic sleeve gastrectomy, sleeve gastrectomy or gastric bypass by laparotomy, no metabolic bariatric surgery (procedure impossible to achieve) |
| control group | – | –patients who underwent laparoscopic gastric bypass. Each patient who had undergone a change in strategy was subsequently randomly matched with three 'controls' who were comparable in terms of age (within 5 years of each other), sex and body mass index (BMI). The controls were defined as patients with the same inclusion criteria as those patients in the 'change of strategy' group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients scheduled for LRYGB surgery at the Nancy University Hospital between 1st October 2012 and 31st December 2022. Patients with body mass index > 35 kg/m2 selected to underwent bariatric surgery by the medical and surgical team Patients with preoperative CT scan
Key inclusion criteria (3 listed)
- All adult patients scheduled for LRYGB surgery at the Nancy University Hospital between 1st October 2012 and 31st December 2022 who underwent a change in intraoperative surgical strategy
- patient who did not object to the collection of their data.
- patients over the age of 18
Key exclusion criteria (2 listed)
- Patients who did not have a preoperative scan
- patients who were lost to follow-up within 6 months of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
left liver volume scannographic measure
Time frame: between 1st October 2012 and 31st December 2022
the Left Liver Volume (LLV) was measured on an abdominal CT scan by a raidologist
3 secondary outcomes
parietal thickness
Time frame: between 1st October 2012 and 31st December 2022
surgical experience, number of bariatric procedure done before the surgery studied (less than 100 procedures or more)
Time frame: between 1st October 2012 and 31st December 2022
Post operative morbidity
Time frame: between 1st October 2012 and 30st June 2023
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 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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 Obesity & Overweight, run by Central Hospital, Nancy, France 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 3 inclusion and 2 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 22 Dec 2025. 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?
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?
left liver volume scannographic measure (time frame: between 1st October 2012 and 31st December 2022). 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 22 Dec 2025.