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Trends and Safety in Revisional Bariatric Surgery in Italy

NCT05194943 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-01-18

No results posted yet for this study

Summary

Background: Revisional bariatric surgery (RBS) represents a further solution for patients who experience an inadequate response following initial bariatric surgery or significant weight regain following an initial satisfactory response. Studies including the follow-up of patients with complications after RBS are still lacking. Aim: to analyze the trend, mortality, and complications at 30 days after RBS in Italy. Secondary aim: 30-day readmission rate, reoperations for any reason related to bariatric surgery. Design: longitudinal, prospective, multicenter study. Time interval: 10 months October 2021 - July 2022). Setting: 11 high-volume bariatric centers of the Italian National Health Service (SSN), university hospitals, hospitals, accredited private centers. Methods: All patients undergoing RBS from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering indications, technique, mortality, intraoperative and perioperative complications, readmission for any reason. All participating centers follow the same preoperative work-up protocol, indications, informed consent, and postoperative follow-up, including scheduled telephone and outpatient visits after 7, 15 and 30 postoperative days. Inclusion criteria: revisional procedures; no concomitant procedure, but hiatal hernia repair; age \>18\<60 years; compensated comorbidities; informed consent including COVID-19 addendum; adherence to specific admission, in-hospital and follow-up protocols. Patients undergone RBS during 2016-2020 will be considered a control group. The study will not involve any modification of the usual protocols. Statistical analyze: to make qualitative quantitative comparison regarding clinical and anthropometric factors between the two study groups (2021-22; 2016-20), the z-test for two proportions and t-test (two-tailed) will be used, respectively. The significance is fixed at 0.05 and all analyzes will be performed with the SPSS v.27 software. Expected results: enroll about 500 patients to obtain information on the safety of RBS and the current trends in Italy.

Conditions

  • Obesity, Morbid
  • Bariatric Surgery Candidate
  • Remission
  • Complication,Postoperative
  • Complication of Surgical Procedure
  • Safety Issues

Interventions

PROCEDURE

revisional bariatric surgical procedures

Any procedure performed as a second or third after an initial, primary bariatric surgery, performed due to complications or due to scarce results in term of weight loss and comorbidities improvement

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Gianfranco Silecchia, MD, PhD · Sapienza University of Rome, Italy

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-06-30
Completion
2022-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194943 on ClinicalTrials.gov