Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-02-01
2024-10-01
Brief Summary
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Detailed Description
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Those who underwent surgery below the age of 35 years between 2000 and 2020 will be included. The study aims to obtain information on female fertility, pregnancy and delivery, and to identify factors associated with infertility and problems to conclude the pregnancy.
For each nation, at least one centre will collect data on patients who were not treated with surgery.
Patients who meet inclusion criteria will be asked to prospectively fill a questionnaire on fertility and pregnancy.
Data on treatments and demographic will be retrospectively collected by the local investigators and uploaded on a secure online database.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Crohn's disease
Patients with Crohn's disease.
Any surgery
Any surgical procedures performed for inflammatory bowel diseases
Any medical treatment
Any treatment (including non-surgical) performed for inflammatory bowel diseases
Ulcerative colitis
Patients with Ulcerative colitis
Any surgery
Any surgical procedures performed for inflammatory bowel diseases
Any medical treatment
Any treatment (including non-surgical) performed for inflammatory bowel diseases
Interventions
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Any surgery
Any surgical procedures performed for inflammatory bowel diseases
Any medical treatment
Any treatment (including non-surgical) performed for inflammatory bowel diseases
Eligibility Criteria
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Inclusion Criteria
* ulcerative disease diagnosis
* operated on before 36 years of age
Exclusion Criteria
* no definitive diagnosis
* no surgical procedures performed
A subgroup of patients who did not undergo surgery will be used, at least one for each country.
18 Years
35 Years
FEMALE
No
Sponsors
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University of Bologna
OTHER
University of Rome Tor Vergata
OTHER
Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
OTHER
University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Gianluca Pellino
Lecturer
Principal Investigators
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Giuseppe Sica, MD, PhD
Role: STUDY_CHAIR
University Tor Vergata Roma
Matteo Rottoli, MD, PhD
Role: STUDY_CHAIR
University Alma Mater Bologna
Francesco Selvaggi, MD, PhD
Role: STUDY_CHAIR
University of Campania Luigi Vanvitelli Napoli
Locations
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Policlinico S.Orsola-Malpighi
Bologna, , Italy
Rho Memorial Hospital
Milan, , Italy
Universitá degli Studi della Campania Luigi Vanvitelli
Napoli, , Italy
Policlinico Tor Vergata
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Matteo Rottoli, MD, PhD
Role: primary
Gianluca M Sampietro
Role: primary
References
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M Rottoli, P Pezzuto, G Fallani, G Pellino, F Rizzello, P Gionchetti, G Poggioli. P199 Ileal pouch-anal anastomosis in women of childbearing age affected by ulcerative colitis: a single-centre study on the risk factors for infertility and outcomes of pregnancy over 17 years. Journal of Crohn's and Colitis, Volume 16, Issue Supplement_1, January 2022, Pages i259-i261, https://doi.org/10.1093/ecco-jcc/jjab232.326
Bernell O, Lapidus A, Hellers G. Risk factors for surgery and recurrence in 907 patients with primary ileocaecal Crohn's disease. Br J Surg. 2000 Dec;87(12):1697-701. doi: 10.1046/j.1365-2168.2000.01589.x.
Spinelli A, Sacchi M, Bazzi P, Leone N, Danese S, Montorsi M. Laparoscopic surgery for recurrent Crohn's disease. Gastroenterol Res Pract. 2012;2012:381017. doi: 10.1155/2012/381017. Epub 2012 Jan 2.
Cosnes J, de Parades V, Carbonnel F, Beaugerie L, Ngo Y, Gendre JP, Sezeur A, Gallot D, Malafosse M, le Quintrec Y. Classification of the sequelae of bowel resection for Crohn's disease. Br J Surg. 1994 Nov;81(11):1627-31. doi: 10.1002/bjs.1800811122.
Pellino G, Keller DS, Sampietro GM, Carvello M, Celentano V, Coco C, Colombo F, Geccherle A, Luglio G, Rottoli M, Scarpa M, Sciaudone G, Sica G, Sofo L, Zinicola R, Leone S, Danese S, Spinelli A, Delaini G, Selvaggi F; Italian Society of Colorectal Surgery SICCR. Inflammatory bowel disease position statement of the Italian Society of Colorectal Surgery (SICCR): ulcerative colitis. Tech Coloproctol. 2020 May;24(5):397-419. doi: 10.1007/s10151-020-02175-z. Epub 2020 Mar 2.
Calvet X, Panes J, Alfaro N, Hinojosa J, Sicilia B, Gallego M, Perez I, Lazaro y de Mercado P, Gomollon F; Members of Consensus Group; Aldeguera X, Alos R, Andreu M, Barreiro M, Bermejo F, Casis B, Domenech E, Espin E, Esteve M, Garcia-Sanchez V, Lopez-Sanroman A, Martinez-Montiel P, Luis Mendoza J, Gisbert JP, Vera M, Dosal A, Sanchez E, Marin L, Sanroman L, Pinilla P, Murciano F, Torrejon A, Ramon Garcia J, Ortega M, Roldan J. Delphi consensus statement: Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units. J Crohns Colitis. 2014 Mar;8(3):240-51. doi: 10.1016/j.crohns.2013.10.010. Epub 2013 Dec 2.
Rajaratnam SG, Eglinton TW, Hider P, Fearnhead NS. Impact of ileal pouch-anal anastomosis on female fertility: meta-analysis and systematic review. Int J Colorectal Dis. 2011 Nov;26(11):1365-74. doi: 10.1007/s00384-011-1274-9. Epub 2011 Jul 16.
Waljee A, Waljee J, Morris AM, Higgins PD. Threefold increased risk of infertility: a meta-analysis of infertility after ileal pouch anal anastomosis in ulcerative colitis. Gut. 2006 Nov;55(11):1575-80. doi: 10.1136/gut.2005.090316. Epub 2006 Jun 13.
Beyer-Berjot L, Maggiori L, Birnbaum D, Lefevre JH, Berdah S, Panis Y. A total laparoscopic approach reduces the infertility rate after ileal pouch-anal anastomosis: a 2-center study. Ann Surg. 2013 Aug;258(2):275-82. doi: 10.1097/SLA.0b013e3182813741.
Gorgun E, Cengiz TB, Aytac E, Aiello A, da Silva G, Goldberg JM, Holubar SD, Stocchi L, Wexner SD, Steele SR, Hull TL. Does laparoscopic ileal pouch-anal anastomosis reduce infertility compared with open approach? Surgery. 2019 Oct;166(4):670-677. doi: 10.1016/j.surg.2019.04.045. Epub 2019 Aug 14.
Other Identifiers
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Fertile-IBD
Identifier Type: -
Identifier Source: org_study_id
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