Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula (SOPA)
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|ClinicalTrials.gov Identifier: NCT05330416|
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : June 30, 2022
In patients with Crohn's disease, anal fistulas are usually treated in three stages: 1) close examination of the fistula and drainage with a seton, 2) pharmacological treatment of the inflammatory component, and 3) closure of the fistulous tract by a sphincter-sparing technique. Setons are used to ensure the permeability of the fistulous tract, to decrease the rate of re-intervention due to the formation of new abscesses or tracts. A seton is a small, often elastic, thread used for drainage. It is inserted into the fistulous tract, passing from the external orifice of the fistula (close to the anus or, in some cases, the vaginal) through the fistula and exiting via the anal orifice.
Seton use seems to minimize colonization of the mucosa of the fistulous tract by the intestinal flora, leukocyte infiltration, and the spread of inflammation within the fistulous tract. Most clinical practice guidelines advocate the use of a seton, but the level of evidence for the efficacy of this approach remains low (D, EL5). Indeed, only a few open studies have reported seton use to be potentially beneficial. In the retrospective study of 32 patients by Regueiro et al., a surgery group with seton insertion before treatment with infliximab was compared with a group on infliximab, without a seton, from the outset. Response rates were better in the group of patients with a seton, with a lower rate of recurrence and a longer time to recurrence than for the seton-less group. Another retrospective study by Schwartz et al. compared two groups - seton (n = 326) and no seton (n = 1519) - in patient with at least six months of biotherapy in three states of the USA. There were more hospitalizations and higher costs generated by greater use of the healthcare system in the group treated without a seton than in those with a seton.
The systematic use of setons in the context of Crohn's disease was inspired by the management of cryptoglandular fistula. However, the protective value of setons in this context remains far from clear, due to a lack of studies providing high-level evidence. Furthermore, the impact of seton use on patient quality of life has been little evaluated.
Investigators aim to determine whether the insertion of one or more setons in anal fistulas in Crohn's disease patients significantly alters patient quality of life. Investigators will perform a randomized controlled trial comparing two strategies: drainage surgery with and without seton use.
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Device: Group Reference Strategy Other: Group Test Strategy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Randomized, open-label, single-center, controlled, superiority study comparing quality of life in two groups of patients operated on for ano-perineal suppuration in Crohn's disease:
|Masking:||None (Open Label)|
|Official Title:||Randomized Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula|
|Actual Study Start Date :||May 25, 2022|
|Estimated Primary Completion Date :||May 24, 2024|
|Estimated Study Completion Date :||May 24, 2025|
Active Comparator: Group Reference Strategy
Detailed examination of the suppuration and drainage with a seton
Device: Group Reference Strategy
Patients undergoing surgery for anoperineal suppuration in the context of Crohn's disease with detailed examination of the suppuration and drainage with a seton.
Experimental: Group test strategy
Detailed examination of the suppuration without drainage via a seton
Other: Group Test Strategy
Patients undergoing surgery for anoperineal suppuration in the context of Crohn's disease with detailed examination of the suppuration without drainage via a seton.
- Quality of life in Crohn's disease patients undergoing surgery for an anal fistula [ Time Frame: Month 12 ]This outcome corresponds to the comparison of quality of life with The Crohn's Anal Fistula Quality of Life (CAF-QoL) scale with 28 simple questions covering three areas: fistula-related symptoms, treatment-related symptoms and quality of life. The CAF-QoL scale is ready for use as a PROM in research and clinical practice. It complements objective clinical evaluation of fistula by capturing impact on the patient.
- Clinical cure rate at 6 months [ Time Frame: Month 6 ]This outcome corresponds to Clinical cure defined by: absence of seton, closure of secondary orifices, absence of leakage under pressure and absence of new suppuration.
- Clinical cure rate at 12 months [ Time Frame: Month 12 ]This outcome corresponds to Clinical cure defined by: absence of seton, closure of secondary orifices, absence of leakage under pressure and absence of new suppuration.
- Rate of re-interventions for the drainage of a new abscess or a new fistula at 12 months [ Time Frame: Month 12 ]This outcome corresponds to the Number of re-interventions for the drainage of a new abscess and/or fistula (operations to close the fistulous tract excluded).
- Radiological cure rate, as determined by MRI at 12 months [ Time Frame: Month 12 ]This outcome corresponds to the absence of T2 hyperintensity, contrast uptake after injection of gadolinium and abscess > 2 cm.
- Rate of use of sphincter-sparing techniques at 12 months [ Time Frame: Month 12 ]This outcome corresponds to the rate of use of sphincter-sparing techniques (simple removal of the seton, rectal lowering flap, FiLaC laser, biological glue, intersphincter ligation of the fistulous tract, injection of mesenchymal stem cells).
- Clinical and radiological cure rate at 12 months in the group of patients receiving an injection of mesenchymal stem cells [ Time Frame: Month 12 ]This outcome corresponds to the Clinical and radiological cure rate (pre-defined criteria).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05330416
|Contact: Nadia Fathallah, MD||1 44 12 71 83 ext +firstname.lastname@example.org|
|Contact: Helene BEAUSSIER, PharmD, PhD||144127901 ext +email@example.com|
|Groupe Hospitalier Paris Saint-Joseph||Recruiting|
|Paris, France, 75014|
|Contact: Nadia Fathallah, MD|
|Principal Investigator:||Nadia Fathallah, MD||Groupe Hospitalier Paris Saint Joseph|