Informations générales (source: ClinicalTrials.gov)
Multicenter Randomized 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. (SIGMOIDITE)
Interventional
N/A
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
novembre 2012
novembre 2017
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Louis Mourier | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| chirurgie digestive et générale, Hôpital C Huriez Place de Verdun - Lille - France | Contact (sur clinicalTrials) | ||||
| Chirurgie générale et digestive,Hôpital de Hautepierre, - 67098 - Hôpital de Hautepierre - STRASBOURG cedex - France | Contact (sur clinicalTrials) | ||||
| Service de chirurgie digestiveCentre Hospitalier Bretagne Sud - 56100 - Lorient - France | David GUINIER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, - 56000 - Vannes - France | Contact (sur clinicalTrials) | ||||
| Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière - Paris - France | Mehdi KAROUI, MD | Contact (sur clinicalTrials) | |||
| Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec - 68100 - Mulhouse - France | DAN Sébastien, MD | Contact (sur clinicalTrials) | |||
| Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Chirurgie générale et digestive,Hôpital de Hautepierre, - 67098 - Strasbourg - Alsace - France | Cécile BRIGAND, MD, PDH | Contact (sur clinicalTrials) | |||
| CHU Amiens Nord Place Victor Pauchet - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Clinique Universitaire de Chirurgie Digestive et de l'Urgence - BP 217 - Grenoble - CHU de Grenoble - France | Catherine ARVIEUX, MD, PHD | Contact (sur clinicalTrials) | |||
| Service de chirurgie digestive Hotel Dieu - 63058 - Clermont ferrand - France | Contact (sur clinicalTrials) | ||||
| Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré - 75475 Paris cedex 10 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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