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New treatment option for Peritonitis
Official title Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
ClinicalTrials.gov ID: NCT04604730
What this study is testing
- What it's testing
- This study is designed to be a multicentre, prospective, comparative, randomised trial, evaluating the efficacy of two surgical strategies for the treatment of generalised peritonitis due to perforated diverticulitis. Results will be analysed according to an intention to treat principle (after selection and patient consent).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Patients operated for purulent or fecal peritonitis (Hinchey grade III and IV) secondary to perforated diverticulitis of the left colon and treated...
- Person informed and having signed his consent. If the patient is unable to sign his consent, the consent will be signed by his representative ((1)...
- Patient able to comply with the study protocol, in the investigator's judgment
- Patient affiliated with, or beneficiary of a social security (health insurance) category Non-
You likely can't join if
- 1\. Failure to obtain the consent of the patient or the patient's representative
See the full eligibility criteria
- Age ≥ 18 years
- Patients operated for purulent or fecal peritonitis (Hinchey grade III and IV) secondary to perforated diverticulitis of the left colon and treated by resection with primary anastomosis
- Person informed and having signed his consent. If the patient is unable to sign his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a...
- Patient able to comply with the study protocol, in the investigator's judgment
- Patient affiliated with, or beneficiary of a social security (health insurance) category Non-
- Physical states that prevent patient participation (e.g. septic shock or multivisceral failure)
- Steroid treatment \> 20 mg daily
- Prior pelvic irradiation
- Immunocompromised status
- Known progressive cancer
- American Society of Anesthesiologists grade IV
- Peritonitis secondary to perforated diverticulitis of the right colon
- Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study
- Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Simultaneous participation in another treatment research
- 1\. Failure to obtain the consent of the patient or the patient's representative
The study team makes the final eligibility decision.
Where it's taking place
- Beauvais, Beauvais, France
- Amiens, France
- Beauvais, France
- Besançon, France
- Bobigny, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Grenoble, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nancy, France
- Nantes, France
- Nîmes, France
- Paris, France
- Rouen, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beauvais, Beauvais, France; Amiens, France; Beauvais, France; Besançon, France; Bobigny, France; Brest, France and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.