Scannographic Predictive Factors of Change of Strategy During Metabolic Bariatric Surgery

NCT07296224 | Completed DMC

• 1 other identifier: FORM-03935
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obesity & Overweight

Keywords

metabolic bariatric surgery; obesity; gastric bypass; sleeve

Outcome Measures

Primary Outcomes (1)

• left liver volume scannographic measure

  the Left Liver Volume (LLV) was measured on an abdominal CT scan by a raidologist

  between 1st October 2012 and 31st December 2022

Secondary Outcomes (3)

• parietal thickness

  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)

  between 1st October 2012 and 31st December 2022

• Post operative morbidity

  between 1st October 2012 and 30st June 2023

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Patients who did not have a preoperative scan
• patients who were lost to follow-up within 6 months of surgery

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nancy

Nancy, Grand Est, 54000, France

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Head of endocrine surgery Unit

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 22, 2025
• Study Start: May 8, 2023
• Primary Completion: July 20, 2023
• Study Completion: September 20, 2023
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)