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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Centre Hospitalier Universitaire de Nancy

    Nancy, Grand Est, 54000

Other trials in France

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.

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 groups in NCT07296224
Study groupRoleWhat they receive
Patients who underwent a change of surgical strategypatients 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 grouppatients 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.

  1. 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)
  1. parietal thickness

    parietal thickness was measured on abdominal CT scan

    Measured: between 1st October 2012 and 31st December 2022

  2. 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

  3. 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.

  1. First posted22 Dec 2025
  2. Study start8 May 2023
  3. Primary completion20 Jul 2023
  4. Study completion20 Sep 2023

Resources

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)
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

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.

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