Trends and Safety in Revisional Bariatric Surgery in Italy

NCT05194943 | Unknown

• 1 other identifier: RBST2021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 11

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 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

Keywords

revisional bariatric surgery; safety bariatric surgery; insufficient weight loss; weight regain; gastroesophageal reflux

Outcome Measures

Primary Outcomes (2)

• Mortality

  Mortality after revisional bariatric surgery

  first 30 postoperative days

• Complications

  complications after revisional bariatric surgery

  first 30 postoperative days

Secondary Outcomes (2)

• Readmission

  first 30 postoperative days

• Reoperations

  first 30 postoperative days

Study Arms (11)

1. UOC Chirurgia Bariatrica, Policlinico San Marco, Zingonia, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

2. UOC di Chirurgia Bariatrica e Metabolica, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

3. UOSD Week Surgery, Chirurgia Bariatrica, Azienda Ospedale-Università di Padova, Padova, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

4. Unita di Chirurgia dell'Obesità e Metabolica, Azienda Ospedaliero-Universitaria, Bologna, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

5. UO Chirurgia Generale, Policlinico San Marco di Zingonia, Zingonia, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

6. UOC Chirurgia Bariatrica e Metabolica, Ospedale San Carlo di Nancy , Roma, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

7. Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria, Torino, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

8. UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

9. UOC Chirurgia Generale & Bariatric Center of Excellence IFSO-EC, Latina, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

10. UOC Chirurgia Generale, Ospedale Villa d'Agri, Potenza, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

11. UOC di Chirurgia Generale e d'Urgenza, Presidio Ospedaliero ARNAS, Catania, Italy

All patients undergoing revisional bariatric surgery in this center from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering reasons for surgery, technique, mortality, intraoperative and perioperative complications, readmission for any reason, following 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.

Procedure: revisional bariatric surgical procedures

Interventions

revisional bariatric surgical procedures PROCEDURE

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

1. UOC Chirurgia Bariatrica, Policlinico San Marco, Zingonia, Italy; 10. UOC Chirurgia Generale, Ospedale Villa d'Agri, Potenza, Italy; 11. UOC di Chirurgia Generale e d'Urgenza, Presidio Ospedaliero ARNAS, Catania, Italy; 2. UOC di Chirurgia Bariatrica e Metabolica, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy; 3. UOSD Week Surgery, Chirurgia Bariatrica, Azienda Ospedale-Università di Padova, Padova, Italy; 4. Unita di Chirurgia dell'Obesità e Metabolica, Azienda Ospedaliero-Universitaria, Bologna, Italy; 5. UO Chirurgia Generale, Policlinico San Marco di Zingonia, Zingonia, Italy; 6. UOC Chirurgia Bariatrica e Metabolica, Ospedale San Carlo di Nancy , Roma, Italy; 7. Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria, Torino, Italy; 8. UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano, Italy; 9. UOC Chirurgia Generale & Bariatric Center of Excellence IFSO-EC, Latina, Italy

Eligibility Criteria

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

Study Population

Group A: all consecutive patients undergoing RBS between November 2021 - April 2022 in all involved centers; Group B (control): all patients operated on for RBS during the 2016-2020 period, in the same semester (November - April) in all involved centers will be considered as a comparative group. All data will be collected anonymously, on a prospective, online database, with a dedicated website. Each centre will have its own slot for data submission like anthropometrics and date of primary BS, weight loss evolution, and reasons, date and anthropometrics for RBS, as well as 30-day postoperative evolution. The prospective observational study will not involve any major modification of the already established protocols, in use in each individual centers.

You may qualify if:

• 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.
• 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);

You may not qualify if:

• other revisional bariatric procedures than ones approved;

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (11)

UOC Chirurgia Generale, Ospedale Villa d'Agri

Potenza, Basilicate, 85050, Italy

RECRUITING

University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies

Latina, LT, 04100, Italy

RECRUITING

UOSD Week Surgery, Chirurgia Bariatrica, Azienda Ospedale-Università di Padova

Padua, Veneto, 35128, Italy

RECRUITING

Policlinico San Marco, Istituti Ospedalieri Bergamaschi, GSD

Bergamo, 24040, Italy

RECRUITING

UO Chirurgia Generale, Policlinico San Marco, Istituti Ospedalieri Bergamaschi, GSD

Bergamo, 24046, Italy

RECRUITING

Unita di Chirurgia dell'Obesità e Metabolica, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Centre for the Study and Research of Treatment for Morbid Obesity, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna,

Bologna, 40126, Italy

RECRUITING

UOC di Chirurgia Generale e d'Urgenza, Presidio Ospedaliero ARNAS Garibaldi Nesima

Catania, 95122, Italy

RECRUITING

UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano

Milan, 20089, Italy

RECRUITING

UOC di Chirurgia Bariatrica e Metabolica, Azienda Ospedaliera Universitaria Pisana, Presidio Ospedaliero "Nuovo Santa Chiara"

Pisa, 56126, Italy

RECRUITING

UOC Chirurgia Bariatrica e Metabolica, Ospedale San Carlo di Nancy e Universita ''Tor Vergata" di Roma

Roma, 00165, Italy

RECRUITING

Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Università di Torino

Torino, 10126, Italy

RECRUITING

Related Publications (17)

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  PMID: 32328827 RESULT

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  PMID: 18650632 RESULT

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MeSH Terms

Conditions

Obesity, Morbid; Postoperative Complications; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gianfranco Silecchia, MD, PhD

  Sapienza University of Rome, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristian E Boru, MD, PhD

CONTACT

00393287441749; cristian.boru@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 18, 2022
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (11)