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Ulcerative ColitisCOLISURGNCT03504930

COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity.

An observational study of Ulcerative Colitis, run by Hospices Civils de Lyon at 22 sites in France.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The surgical treatment of the ulcerative colitis (UC) remains associate to a significant morbidity (up to 60%). Anastomotic fistula and pelvic sepsis are the most severe complications which could dramatically compromise the surgical issue and functional status. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Impact of biotherapy on postoperative morbidity in ulcerative colitis
How many people
330 participants
Where
22 sitesFrance
Study dates
7 Jun 2018to 7 Dec 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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

Who may be able to join

  • Age ≥ 13 ans
  • Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

Who cannot join

  • Age < 13 ans
  • Under any administrative or legal supervision

Trial locations and contacts

22 sites in 1 country.

Eddy COTTE, MD contact

04 78 86 23 71 ext. +33

eddy.cotte@chu-lyon.fr

Quentin DENOST, MD contact

05 56 79 58 10 ext. +33

quentin.denost@chu-bordeaux.fr

22 sites in 1 country

France22 sites, 22 recruiting

  • Centre Hospitalier Universitaire de Besançon

    Besançon

    Zaher LAKKIS, MD, zlakkis@chu-besancon.fr

    Zaher LAKKIS, MD

    Recruiting

  • Centre Hospitalier Universitaire de Caen

    Caen

    Arnaud ALVES, MD

    alves-a@chu-caen.fr

    Not yet recruiting

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand

    Anne DUBOIS, MD, a_dubois@chu-clermontferrand.fr

    Anne DUBOIS, MD

    Not yet recruiting

  • APHP - Hôpital Beaujon

    Clichy

    Yves PANIS, MD, yves.panis@aphp.fr

    Yves PANIS, MD

    Recruiting

  • Centre Hospitalier Universitaire de Grenoble

    La Tronche

    Jean-Luc FAUCHERON, MD, JLFaucheron@chu-grenoble.fr

    Jean-Luc FAUCHERON, MD

    Recruiting

  • APHP - Hôpital Kremlin-Bicêtre

    Le Kremlin-Bicêtre

    Antoine BROUQUET, MD, antoine.brouquet@aphp.fr

    Antoine BROUQUET, MD

    Recruiting

  • Centre Hospitalier Universitaire de Lille

    Lille

    Philippe ZERBIB, MD, Philippe.ZERBIB@CHRU-LILLE.FR

    Philippe ZERBIB, MD

    Recruiting

  • APHM - Hôpital Nord

    Marseille

    Laura BEYER-BERJOT, MD, Laura.BEYER@ap-hm.fr

    Laura BEYER-BERJOT, MD

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II

    Nice

    Amine RAHILI, MD, rahili.ma@chu-nice.fr

    Amine RAHILI, MD

    Recruiting

  • APHP - Hôpital Cochin

    Paris

    Mahaut LECONTE, MD, mahaut.leconte@aphp.fr

    Mahaut LECONTE, MD

    Not yet recruiting

  • APHP - Hôpital Européen Georges Pompidou

    Paris

    Richard DOUARD, MD, richard.douard@aphp.fr

    Richard DOUARD, MD

    Not yet recruiting

  • APHP - Hôpital St Antoine

    Paris

    Jérémie LEFEVRE, MD, jeremie.lefevre@aphp.fr

    Jérémie LEFEVRE, MD

    Recruiting

  • APHP - Hôpital St Louis

    Paris

    Hélène CORTE, MD, helenecorte@hotmail.com

    Hélène CORTE, MD

    Not yet recruiting

  • Institut Mutualiste Montsouris

    Paris

    Christine DENET, MD, Christine.Denet@imm.fr

    Christine DENET, MD

    Not yet recruiting

  • Hôpital Haut-Lévêque

    Pessac

    Quentin DENOST, MD, 05 56 79 58 10 ext. +33, quentin.denost@chu-bordeaux.fr

    Quentin DENOST, MD

    Recruiting

  • Centre Hospitalier Lyon SUD

    Pierre-Bénite

    Eddy COTTE, MD, 04 78 86 23 71 ext. +33, eddy.cotte@chu-lyon.fr

    Eddy COTTE, MD

    Recruiting

  • Centre Hospitalier Universitaire de Rennes

    Rennes

    Véronique DESFOURNEAUX, MD, Veronique.DESFOURNEAUX-DENIS@chu-rennes.fr

    Véronique DESFOURNEAUX, MD

    Recruiting

  • Centre Hospitalier Universitaire de Rouen

    Rouen

    Jean-Jacques TUECH, MD, jean-jacques.tuech@chu-rouen.fr

    Jean-Jacques TUECH, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg

    Cécile BRIGAND, MD, Cecile.BRIGAND@chru-strasbourg.fr

    Cécile BRIGAND, MD

    Recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse

    Jean-Pierre DUFFAS, MD, duffas.jp@chu-toulouse.fr

    Jean-Pierre DUFFAS, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Tours

    Tours

    Mehdi OUAISSI, MD, M.OUAISSI@chu-tours.fr

    Mehdi OUAISSI, MD

    Recruiting

  • Centre Hospitalier Universitaire de Nancy

    Vandœuvre-lès-Nancy

    Adeline GERMAIN, MD, a.germain@chru-nancy.fr

    Adeline GERMAIN, MD

    Recruiting

Other trials in France

About this study

Official title: COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.

The surgical treatment of the ulcerative colitis (UC) remains associate to a significant morbidity (up to 60%). Anastomotic fistula and pelvic sepsis are the most severe complications which could dramatically compromise the surgical issue and functional status. Thanks to the current therapeutic arsenal and the evolution of health care paradigms, the quality of life of patients plays a key role in the modern global management of these medical conditions. Biotherapies (e.g anti-TNF) are widely used to treat patients with UC. Anti-TNF and anti-integrins have an effect on the immune response and can theoretically aggravate the infectious disease. Their potential impact on postoperative complications after ileo anal anastomosis (AIA) remains debated. Very few studies have looked at other biotherapies including vedolizumab. All studies are retrospective series with small sample size. Here again the conclusion remain contradictory. Lightner et al. showed an increased risk of surgical site infection for patients preoperatively exposed to vedolizumab (37% vs. 10%, p <0.001). In a dedicated cohort to the RCH, the same author found a risk of increased pelvic abscess (31.3% vs 5.9%, NS) but the difference was not statistically significant probably for lack of power. Other studies did not find any impact of vedolizumab on the risk of postoperative complications. To clearly determine within a large prospective cohort the impact of anti-TNF agents and biotherapies on the postoperative complications seems to be essential in order to adapt and to optimize the therapeutic strategy, especially the surgical sequences, in patients with UCR whom benefit a surgery.

Being tested
Impact of biotherapy on postoperative morbidity in ulcerative colitis
Keywords
Surgical, Ileal pouch-anal anastomosis
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Impact of biotherapy on postoperative morbidity in ulcerative colitisOther

    Impact of biotherapy on postoperative morbidity, quality of life, sexual function, sexual health in ulcerative colitis

Study groups in NCT03504930
Study groupRoleWhat they receive
Impact of biotherapy on postoperative morbidityImpact of biotherapy on postoperative morbidity in ulcerative colitis
Receives: Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis

What is being measured

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

  1. Infectious complications at D30 postoperative

    Infectious complications during the first month (D30) after surgery (D0)

    Measured: First month (Day 30) after surgery (Day 0)

Timeline

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

  1. First posted20 Apr 2018
  2. Study start7 Jun 2018
  3. Primary completionJun 2022 (estimated)
  4. Study completion7 Dec 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
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504930
Sponsor's protocol ID
69HCL18_0178
Acronym
COLISURG
Status last verified
Jul 2021
First submitted
12 Apr 2018
Last updated
28 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Hospices Civils de Lyon at 22 sites in France.

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 2 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. 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 Eddy COTTE, MD (04 78 86 23 71 ext. +33, eddy.cotte@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infectious complications at D30 postoperative (time frame: First month (Day 30) after surgery (Day 0)). 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 NCT03504930.

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 28 Jul 2021.

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