Trends and Safety in Revisional Bariatric Surgery in Italy

Bariatric Surgery Candidate Clinical Trial

Official title:

Trends and Safety in Revisional Bariatric Surgery in Italy: a High Volume Multicenter, Observational Longitudinal Study (RBST)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194943
• Other study ID #: RBST2021
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2022
• Source: University of Roma La Sapienza
• Contact: Cristian E Boru, MD, PhD
• Phone: 00393287441749
• Email: cristian.boru[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 syndrome [1]. Revisional bariatric surgery (RBS) is an option for patients who have an inadequate response after bariatric surgery for weight loss and improvement/resolution of comorbidities, or significant weight regain after a satisfactory, initial response, even with comorbidities' relapse [2,3]. All bariatric procedures are subject to failure, in different proportions, based on the type and mechanism of action and the patient's compliance to follow-up. Recent studies suggest that revision rates for sleeve gastrectomy, which is the most performed bariatric surgery in the world since 2015 [4], can be as high as 10% when patients are followed for more than 3 years and as high as 22%. after 10 years [5].

Revisional bariatric surgery is a constantly growing set of procedures. The choice of the revision procedure must consider the indication, the primary technique, and the patient's characteristics [3,6-9]. There is a lack of high-quality studies and an almost total lack of randomized data [6] on various aspects of RBS. These factors make it difficult for individual surgeons treating these patients to know which RBS procedures to recommend to their patients, not least because there are no guidelines for choosing RBS [7].

As defined by the American Society for Metabolic and Bariatric Surgery (ASMBS) Revision Task Force, RBS includes conversion (procedures that change from one initial procedure to a different type), correction (procedures that address complications), and reversal (procedures that restore the original anatomy) [10].

RBS results in higher mortality and complication rates than primary procedures [5,6,11]. However, the literature reports an increasing trend in the percentage of "conversion" intent revision surgeries for IWL or WR based on self-referencing surgical center choices, in the absence of solid outcome data [3]. There is a lack of Italian data documenting the trend of RBS in the last 5 years (% of interventions for high-volume centers), the indications for "conversion", types of intervention and, above all, data on mortality and postoperative complications, essential for the informed consent offered to the patient candidate to RBS.

PRIMARY AIM: To analyze the trend, mortality, and complications at 30 days. SECONDARY AIMS:

30-day readmission rate, reoperations for any reason related to bariatric surgery.

Study's design: longitudinal, prospective, multicenter study. Time interval: 10 months (1 month of preparation and enrollment October 2021, 6 months of treatment November 2022 - April 2022, 1 month of follow-up May 2022, 4 months of data collection and analysis, manuscript preparation and publication May - July 2022).

Location: 11 high-volume bariatric centers of the Italian National Health Service (SSN), university hospitals, hospitals, accredited private centers.

METHODS: All bariatric revisional cases operated from 01.11.2021 - 31.04.2022 will be collected in a prospective, online database, within a dedicated website. Will be analyzed: indications; revision technique; mortality; intraoperative complications; perioperative complications; readmission to the hospital after discharge, for any reason.

All participating centers will follow the usual preoperative work-up protocol, surgical indication, informed consent, preparation for surgery and postoperative follow-up. No insurance is needed for this study, as it is an observation of routine clinical practice.

The patients operated on during the 2016-2020 period, in the same semester (November-April) will be considered as a comparative group (control group).

The prospective observational study will not involve any modification of the protocols in use in the individual centers.

Statistical analysis: categorical data will be described by absolute and relative frequency, continuous data by mean, standard deviation, and range. 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. An online platform dedicated to the study for data entry will be used, as per the data collection form (CRF).

The study will be conducted in accordance with the principles of Good Clinical Practice, as well as with the study's protocol under registration within clinicaltrials.gov.

EXPECTED RESULTS: to enroll about 500 patients to obtain information on the safety of RBS and the current trend in Italy. DISCLOSURES: No funding is required or needed for this study. Researchers have nothing to reveal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Previous bariatric surgery;

2. Age:> 18 <65 years;

3. Compensated comorbidities;

4. Official surgical informed consent with Covid-19 addendum in case the state of emergency continues.

5. 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 Criteria:

• no compliance to the inclusion criteria;

• other revisional bariatric procedures than ones approved;

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Policlinico San Marco, Istituti Ospedalieri Bergamaschi, GSD	Bergamo
Italy	UO Chirurgia Generale, Policlinico San Marco, Istituti Ospedalieri Bergamaschi, GSD	Bergamo
Italy	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
Italy	UOC di Chirurgia Generale e d'Urgenza, Presidio Ospedaliero ARNAS Garibaldi Nesima	Catania
Italy	University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies	Latina	LT
Italy	UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano	Milano
Italy	UOSD Week Surgery, Chirurgia Bariatrica, Azienda Ospedale-Università di Padova	Padova	Veneto
Italy	UOC di Chirurgia Bariatrica e Metabolica, Azienda Ospedaliera Universitaria Pisana, Presidio Ospedaliero "Nuovo Santa Chiara"	Pisa
Italy	UOC Chirurgia Generale, Ospedale Villa d'Agri	Potenza	Basilicata
Italy	UOC Chirurgia Bariatrica e Metabolica, Ospedale San Carlo di Nancy e Universita ''Tor Vergata" di Roma	Roma
Italy	Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Università di Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (17)

Abdelgawad M, De Angelis F, Iossa A, Rizzello M, Cavallaro G, Silecchia G. Management of Complications and Outcomes After Revisional Bariatric Surgery: 3-Year Experience at a Bariatric Center of Excellence. Obes Surg. 2016 Sep;26(9):2144-2149. doi: 10.100 — View Citation

Akpinar EO, Marang-van de Mheen PJ, Nienhuijs SW, Greve JWM, Liem RSL. National Bariatric Surgery Registries: an International Comparison. Obes Surg. 2021 Jul;31(7):3031-3039. doi: 10.1007/s11695-021-05359-0. Epub 2021 Mar 30. — View Citation

Angrisani L, Santonicola A, Iovino P, Vitiello A, Higa K, Himpens J, Buchwald H, Scopinaro N. IFSO Worldwide Survey 2016: Primary, Endoluminal, and Revisional Procedures. Obes Surg. 2018 Dec;28(12):3783-3794. doi: 10.1007/s11695-018-3450-2. — View Citation

Athanasiadis DI, Martin A, Kapsampelis P, Monfared S, Stefanidis D. Factors associated with weight regain post-bariatric surgery: a systematic review. Surg Endosc. 2021 Aug;35(8):4069-4084. doi: 10.1007/s00464-021-08329-w. Epub 2021 Mar 1. Review. — View Citation

Boru CE, Greco F, Giustacchini P, Raffaelli M, Silecchia G. Short-term outcomes of sleeve gastrectomy conversion to R-Y gastric bypass: multi-center retrospective study. Langenbecks Arch Surg. 2018 Jun;403(4):473-479. doi: 10.1007/s00423-018-1675-0. Epub — View Citation

Brethauer SA, Kothari S, Sudan R, Williams B, English WJ, Brengman M, Kurian M, Hutter M, Stegemann L, Kallies K, Nguyen NT, Ponce J, Morton JM. Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revis — View Citation

Brolin RE, Cody RP. Weight loss outcome of revisional bariatric operations varies according to the primary procedure. Ann Surg. 2008 Aug;248(2):227-32. doi: 10.1097/SLA.0b013e3181820cdf. — View Citation

Di Lorenzo N, Antoniou SA, Batterham RL, Busetto L, Godoroja D, Iossa A, Carrano FM, Agresta F, Alarçon I, Azran C, Bouvy N, Balaguè Ponz C, Buza M, Copaescu C, De Luca M, Dicker D, Di Vincenzo A, Felsenreich DM, Francis NK, Fried M, Gonzalo Prats B, Goit — View Citation

Guan B, Chong TH, Peng J, Chen Y, Wang C, Yang J. Mid-long-term Revisional Surgery After Sleeve Gastrectomy: a Systematic Review and Meta-analysis. Obes Surg. 2019 Jun;29(6):1965-1975. doi: 10.1007/s11695-019-03842-3. — View Citation

Kellogg TA. Revisional bariatric surgery. Surg Clin North Am. 2011 Dec;91(6):1353-71, x. doi: 10.1016/j.suc.2011.08.004. Review. — View Citation

Koh ZJ, Chew CAZ, Zhang JJY, Syn N, Kim G, Yan So JB, Shabbir A. Metabolic outcomes after revisional bariatric surgery: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Oct;16(10):1442-1454. doi: 10.1016/j.soard.2020.05.029. Epub 2020 Jun — View Citation

Li S, Jiao S, Zhang S, Zhou J. Revisional Surgeries of Laparoscopic Sleeve Gastrectomy. Diabetes Metab Syndr Obes. 2021 Feb 10;14:575-588. doi: 10.2147/DMSO.S295162. eCollection 2021. Review. — View Citation

Mahawar KK, Himpens JM, Shikora SA, Ramos AC, Torres A, Somers S, Dillemans B, Angrisani L, Greve JWM, Chevallier JM, Chowbey P, De Luca M, Weiner R, Prager G, Vilallonga R, Adamo M, Sakran N, Kow L, Lakdawala M, Dargent J, Nimeri A, Small PK. The first c — View Citation

Palermo M, Khwaja H. Overview of Revisional Bariatric Surgery. J Laparoendosc Adv Surg Tech A. 2021 Sep 6. doi: 10.1089/lap.2021.0554. [Epub ahead of print] — View Citation

Radtka JF 3rd, Puleo FJ, Wang L, Cooney RN. Revisional bariatric surgery: who, what, where, and when? Surg Obes Relat Dis. 2010 Nov-Dec;6(6):635-42. doi: 10.1016/j.soard.2010.04.005. Epub 2010 May 4. — View Citation

Stefanidis D, Malireddy K, Kuwada T, Phillips R, Zoog E, Gersin KS. Revisional bariatric surgery: perioperative morbidity is determined by type of procedure. Surg Endosc. 2013 Dec;27(12):4504-10. doi: 10.1007/s00464-013-3097-y. Epub 2013 Aug 14. — View Citation

Vilallonga R, Fort JM, Rodríguez Luna MR, García Ruiz de Gordejuela A, Gonzalez O, Caubet E, Cirera de Tudela A, Palermo M, Ciudin A, Armengol M. The Panoramic View of Revisional Bariatric Surgery. J Laparoendosc Adv Surg Tech A. 2021 Sep 6. doi: 10.1089/ — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality after revisional bariatric surgery	first 30 postoperative days
Primary	Complications	complications after revisional bariatric surgery	first 30 postoperative days
Secondary	Readmission	readmission after revisional bariatric surgery	first 30 postoperative days
Secondary	Reoperations	reoperations for any reason related to revisional bariatric surgery.	first 30 postoperative days