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 around the diverticulum the condition is called diverticulitis. An individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent hospitalisations as a result of the evolution of purulent peritonitis that originates from diverticulitis treated by mini-invasive surgery results. Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic generalized purulent peritonitis of diverticular origin have been identified as therapeutic options by HAS (French health authorities), followed by second stage resection-anastomosis under elective surgery. It has been observed in patients that if only drainage and washing are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore this reduces the risks of postoperatory complications. Some studies have shown that the attitude of non-distance resection of the acute episode was associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity. In addition, the morbidity associated with intervention sigmoid resection is around 30%. The question arises in our daily practice, or not to propose systematic resection of sigmoid diverticulitis after an acute episode of severe purulent peritonitis or abscess types supported initially by minimally invasive. The primary objective of the study is to determine, after clinical improvement linked to conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as currently recommended. The secondary objective of the study is to determine if conservative treatment reduces mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and improves quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Chirurgie générale et digestive,Hôpital de Hautepierre,
Strasbourg, Alsace, France
NOT_YET_RECRUITINGClinique Universitaire de Chirurgie Digestive et de l'Urgence
Grenoble, CHU de Grenoble, France
NOT_YET_RECRUITINGChirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec
Mulhouse, Mulhouse, France
NOT_YET_RECRUITINGChirurgie générale et digestive,Hôpital de Hautepierre,
Hôpital de Hautepierre, Strasbourg Cedex, France
RECRUITINGCHU Amiens Nord Place Victor Pauchet
Amiens, France
NOT_YET_RECRUITINGService de chirurgie digestive Hotel Dieu
Clermont-Ferrand, France
NOT_YET_RECRUITINGChirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers
Colombes, France
NOT_YET_RECRUITINGchirurgie digestive et générale, Hôpital C Huriez Place de Verdun
Lille, France
NOT_YET_RECRUITINGService de chirurgie digestiveCentre Hospitalier Bretagne Sud
Lorient, France
NOT_YET_RECRUITINGUnité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré
Paris, France
NOT_YET_RECRUITING...and 4 more locations
Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity
The primary endpoint is the composite as predictable morbidity is different between groups. It is the occurrence of a disease episode in connection with diverticulosis or its treatment: recurrence of diverticulitis, the need for intervention in the sigmoid resection group drawn for a conservative attitude, postoperative complications Dindo stage ≥ II in case of sigmoid
Time frame: 2 years
Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients
The secondary endpoints were mortality, the number and duration of cumulative report with sigmoid diverticular disease hospitalization, quality of life (SF-36 questionnaire, and QLQ CR29)
Time frame: 2 years
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