Status:
UNKNOWN
Trends and Safety in Revisional Bariatric Surgery in Italy
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Obesity, Morbid
Bariatric Surgery Candidate
Eligibility:
All Genders
18-65 years
Brief 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 followi...
Detailed Description
Bariatric surgery is the most effective treatment for achieving significant long-term weight reduction and resolution of comorbidities, including diabetes mellitus, arterial hypertension, sleep apnea ...
Eligibility Criteria
Inclusion
- Previous bariatric surgery;
- Age:\> 18 \<65 years;
- Compensated comorbidities;
- Official surgical informed consent with Covid-19 addendum in case the state of emergency continues.
- Revisional bariatric procedures approved by: SICOB (Italian Society of Obesity Surgery), EAES (European Association for Endoscopic Surgery) and IFSO (International Federation for Obesity Surgery), including: Roux-en-Y gastric bypass, sleeve gastrectomy or repeated sleeve gastrectomy, biliopancreatic diversion, duodenal switch, duodenal-jejunal bypass, one-anastomosis gastric bypass, single anastomosis duodeno-ileal bypass (SAID), performed exclusively laparoscopically.
- Routine performance expected during the clinical study, as inclusion criteria:
- obtaining the informed consent for participating in the clinical study;
- delivery of the privacy, information and data treatment forms;
- online data collection form's compilation (CRF);
- collection of specific Italian Society of Obesity Surgery (SICOB) informed consent for revisional bariatric surgery, COVID-19 regional questionnaire and SICOB's addendum for bariatric surgery during COVID-19 (attachment 6);
- emission of patients' letter of discharge, indicating the telephone interview after 7 and 15 days and the first outpatient check-up after 30 days;
- information letter for the general practitioner (see attachment 7);
Exclusion
- no compliance to the inclusion criteria;
- other revisional bariatric procedures than ones approved;
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05194943
Start Date
November 1 2021
End Date
August 31 2022
Last Update
January 18 2022
Active Locations (11)
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1
UOC Chirurgia Generale, Ospedale Villa d'Agri
Potenza, Basilicate, Italy, 85050
2
University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies
Latina, LT, Italy, 04100
3
UOSD Week Surgery, Chirurgia Bariatrica, Azienda Ospedale-Università di Padova
Padua, Veneto, Italy, 35128
4
Policlinico San Marco, Istituti Ospedalieri Bergamaschi, GSD
Bergamo, Italy, 24040