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| Name | Class |
|---|---|
| University of Bologna | OTHER |
| University of Rome Tor Vergata | OTHER |
| Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) | OTHER |
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Crohn's disease and Ulcerative colitis are chronic disease that are usually diagnosed at young age. The diseases and the associated treatment can impact on patient's sexual function, fertility, pregnancy, and delivery. This study aims to assess the impact of inflammatory bowel diseases on these aspects in female patients.
This is a cross-sectional, international, multicentre study. Female patients diagnosed with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) treated at several Italian centres will be retrospectively assessed for inclusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn's disease | Patients with Crohn's disease. |
| |
| Ulcerative colitis | Patients with Ulcerative colitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Any surgery | Procedure | Any surgical procedures performed for inflammatory bowel diseases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fertility | Rate of infertility and number of pregnancies. Number of attempts to achieve pregnancy. | through study completion, an average of 1 year |
| Pregnancy | Rate of successful pregnancies. Number of miscarriages. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| In-vitro fertilization | Number of in-vitro fertilization attempts | through study completion, an average of 1 year |
| Abortion/s | Number of abortions and reasons. |
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Inclusion Criteria:
Exclusion Criteria:
A subgroup of patients who did not undergo surgery will be used, at least one for each country.
All female patients will be included
Female patients diagnosed with Crohn's disease or ulcerative colitis, treated when 35-year-old or younger.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianluca Pellino, MD, PhD | Contact | 0815667919 | gianluca.pellino@unicampania.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Sica, MD, PhD | University Tor Vergata Roma | Study Chair |
| Matteo Rottoli, MD, PhD | University Alma Mater Bologna | Study Chair |
| Francesco Selvaggi, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S.Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 11122187 | Result | 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. | |
| 22253619 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D011248 | Pregnancy Complications |
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Any medical treatment | Procedure | Any treatment (including non-surgical) performed for inflammatory bowel diseases |
|
| through study completion, an average of 1 year |
| Complications, surgical | Incidence of early and late surgical complications and effects on fertility | through study completion, an average of 1 year |
| Complications, medical | Incidence of medical complications and effects on fertility | through study completion, an average of 1 year |
| Surgical approach | Rate of minimally invasive surgery use and effect on fertility and pregnancy | through study completion, an average of 1 year |
| University of Campania Luigi Vanvitelli Napoli |
| Study Chair |
| Rho Memorial Hospital | Not yet recruiting | Milan | 20017 | Italy |
|
| Universitá degli Studi della Campania Luigi Vanvitelli | Not yet recruiting | Naples | 81038 | Italy |
|
| Policlinico Tor Vergata | Recruiting | Roma | 00133 | Italy |
|
| Result |
| 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. |
| 7827890 | Result | 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. |
| 32124113 | Result | 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. |
| 24295646 | Result | 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. |
| 21766164 | Result | 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. |
| 16772310 | Result | 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. |
| 23360923 | Result | 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. |
| 31420214 | Result | 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. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007744 | Obstetric Labor Complications |