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Obesity, MorbidNCT05194943

Trends and Safety in Revisional Bariatric Surgery in Italy

An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by University of Roma La Sapienza at 11 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
revisional bariatric surgical procedures
Type of treatment
Surgery or procedure
How many people
500 participants
Where
11 sitesItaly
Study dates
1 Nov 2021to 31 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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);

Who cannot join

  • no compliance to the inclusion criteria;
  • other revisional bariatric procedures than ones approved;

Trial locations and contacts

11 sites in 1 country.

Cristian E Boru, MD, PhD contact

00393287441749

cristian.boru@uniroma1.it

11 sites in 1 country

Italy11 sites, 11 recruiting

  • Policlinico San Marco, Istituti Ospedalieri Bergamaschi, GSD

    Bergamo, 24040

    Marco Anselmino, MD, ‭+393452202727‬, m.anselmino@me.com

    Recruiting

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

    Bergamo, 24046

    Stefano Olmi, MD, Prof, stefano.olmi@gmail.com

    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

    Paolo Bernante, MD, paolo.bernante@aosp.bo.it

    Recruiting

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

    Catania, 95122

    Luigi Piazza, MD, Prof, lpiazza267@gmail.com

    Recruiting

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

    Latina, LT, 04100

    Alessandra Papa, 003907731757245, alessandra.papa@uniroma1.it

    Recruiting

  • UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano

    Milan, 20089

    Giuseppe Marinari, MD, giuseppe.marinari@humanitas.it

    Recruiting

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

    Padova, Veneto, 35128

    Mirto Foletto, ‭+393341015990‬, mirto.foletto@unipd.it

    Recruiting

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

    Pisa, 56126

    Rosario Bellini, MD, r.bellini@ao-pisa.toscana.it

    Recruiting

  • UOC Chirurgia Generale, Ospedale Villa d'Agri

    Potenza, Basilicate, 85050

    Nicola Perrotta, MD, +393476113059‬, perrott@tiscali.it

    Recruiting

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

    Roma, 00165

    Paolo Gentileschi, MD, +393357205712‬, gentileschi.paolo@gmail.com

    Recruiting

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

    Torino, 10126

    Mario Morino, MD, Prof, ‭+390116335670‬, mario.morino@unito.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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 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.

Being tested
revisional bariatric surgical procedures
Keywords
revisional bariatric surgery, safety bariatric surgery, insufficient weight loss, weight regain, gastroesophageal reflux
Medical subject headings
Obesity, Morbid, Postoperative Complications, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • revisional bariatric surgical proceduresProcedure or surgery

    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

Study groups in NCT05194943
Study groupRoleWhat they receive
1. UOC Chirurgia Bariatrica, Policlinico San Marco, Zingonia, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
2. UOC di Chirurgia Bariatrica e Metabolica, Azienda Ospedaliera Universitaria Pisana, Pisa, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
3. UOSD Week Surgery, Chirurgia Bariatrica, Azienda Ospedale-Università di Padova, Padova, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
4. Unita di Chirurgia dell'Obesità e Metabolica, Azienda Ospedaliero-Universitaria, Bologna, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
5. UO Chirurgia Generale, Policlinico San Marco di Zingonia, Zingonia, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
6. UOC Chirurgia Bariatrica e Metabolica, Ospedale San Carlo di Nancy , Roma, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
7. Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria, Torino, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
8. UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
9. UOC Chirurgia Generale & Bariatric Center of Excellence IFSO-EC, Latina, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
10. UOC Chirurgia Generale, Ospedale Villa d'Agri, Potenza, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures
11. UOC di Chirurgia Generale e d'Urgenza, Presidio Ospedaliero ARNAS, Catania, ItalyAll 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.
Receives: Procedure: revisional bariatric surgical procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Mortality after revisional bariatric surgery

    Measured: first 30 postoperative days

  2. Complications

    complications after revisional bariatric surgery

    Measured: first 30 postoperative days

Secondary outcomes (2)

  1. Readmission

    readmission after revisional bariatric surgery

    Measured: first 30 postoperative days

  2. Reoperations

    reoperations for any reason related to revisional bariatric surgery.

    Measured: first 30 postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start1 Nov 2021
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194943
Sponsor's protocol ID
RBST2021
Status last verified
Jan 2022
First submitted
5 Jan 2022
Last updated
18 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23943144

  • 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 consensus statement on revisional bariatric surgery using a modified Delphi approach. Surg Endosc. 2020 Apr;34(4):1648-1657. doi: 10.1007/s00464-019-06937-1. Epub 2019 Jun 19.

    PubMed 31218425

  • 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.

    PubMed 30121858

  • 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.

    PubMed 30903425

  • 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.

    PubMed 33650001

  • 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.

    PubMed 33603423

  • Di Lorenzo N, Antoniou SA, Batterham RL, Busetto L, Godoroja D, Iossa A, Carrano FM, Agresta F, Alarcon I, Azran C, Bouvy N, Balague Ponz C, Buza M, Copaescu C, De Luca M, Dicker D, Di Vincenzo A, Felsenreich DM, Francis NK, Fried M, Gonzalo Prats B, Goitein D, Halford JCG, Herlesova J, Kalogridaki M, Ket H, Morales-Conde S, Piatto G, Prager G, Pruijssers S, Pucci A, Rayman S, Romano E, Sanchez-Cordero S, Vilallonga R, Silecchia G. Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP. Surg Endosc. 2020 Jun;34(6):2332-2358. doi: 10.1007/s00464-020-07555-y. Epub 2020 Apr 23.

    PubMed 32328827

  • 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.

    PubMed 20702147

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

    PubMed 22054158

  • 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.

    PubMed 18650632

  • 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 Revision Task Force. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):952-72. doi: 10.1016/j.soard.2014.02.014. Epub 2014 Feb 22.

    PubMed 24776071

  • 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: 10.1007/s11695-016-2071-x.

    PubMed 26809671

  • 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 6.

    PubMed 32711955

  • 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 2018 Apr 20.

    PubMed 29675614

  • Vilallonga R, Fort JM, Rodriguez Luna MR, Garcia 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/lap.2021.0506. Online ahead of print.

    PubMed 34492201

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by University of Roma La Sapienza at 11 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristian E Boru, MD, PhD (00393287441749, cristian.boru@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: first 30 postoperative days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05194943, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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