Status:
UNKNOWN
Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Peritonitis
Diverticulitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and infection sets in arou...
Eligibility Criteria
Inclusion
- Patients who have had an episode of sigmoid diverticulitis as a result of pelvic or purulent peritonitis (Hinchey stage II and III) complications and treated by conservative treatment such as per cutaneous radiological drainage or laparoscopic-assisted per cutaneous drainage.
- Male and female individuals aged from 18 to 65 years old (both ages included).
- Absence of contra-indication for surgery ASA Score ≤3
- Participants must have signed informed consent document indicating that they understand the purpose and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
- Patients will sign an informed consent after haven been informed of the results of the previous medical visit.
- Patients must be affiliated with, or a beneficiary of a social security system
Exclusion
- Subjects in the exclusion period (haven participated in a previous trial or an ongoing trial )
- Contra- indication to surgery
- ASA Score \>3
- Past history of evolutive neoplasm,
- Subjects unable to consent (case of emergency, subjects having difficulties in understanding)
- Patients for which consultation visits will not be possible (e.g. tourists and people who cannot stay above 18 months in France).
- Pregnant and breastfeeding women
- Subjects under tutorship or curator ship
- Subjets under judicial protection
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01837342
Start Date
November 1 2012
End Date
November 1 2017
Last Update
April 23 2013
Active Locations (14)
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1
Chirurgie générale et digestive,Hôpital de Hautepierre,
Strasbourg, Alsace, France, 67098
2
Clinique Universitaire de Chirurgie Digestive et de l'Urgence
Grenoble, CHU de Grenoble, France, BP 217
3
Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec
Mulhouse, Mulhouse, France, 68100
4
Chirurgie générale et digestive,Hôpital de Hautepierre,
Hôpital de Hautepierre, Strasbourg Cedex, France, 67098