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

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 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.

Conditions

• Peritonitis
• Diverticulitis

Interventions

PROCEDURE

Surgical reserction

OTHER

Radiological percutaneous drainage and washing drainage

Sponsors & Collaborators

• University Hospital, Strasbourg, France

  lead OTHER

Principal Investigators

• Catherine ARVIEUX, MD,PHD · Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217

• Cécile BRIGAND, MD, PHD · Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex

• Sébastien DAN, MD · Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec

• David GUINIER, MD · Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 Lorient

• Mehdi KAROUI, MD · Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,Créteil

• Christophe MARIETTE, MD,PHD · chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille Cedex

• MSIKA Simon, MD · Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 Colombes

• MUSCARI Fabrice, MD, PHD · Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 - TOULOUSE CEDEX

• Marc POCARD, MD, PHD · Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10

• REGIMBEAU Jean Marc, MD · CHU Amiens Nord Place Victor, Pauchet 80054 Amiens

• Didier RIO, MD · Service de chirurgie digestive et viscérale, Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, 56000 Vannes

• Karim SLIM, MD,PHD · Service de chirurgie digestive Hotel Dieu, Bd Léon Malfreyt

• Bertrand SUC, MD · Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire de TOULOUSE - RANGUEIL Avenue Jean Poulhes 31054 - TOULOUSE CEDEX

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2017-08-31

Completion

2017-11-30

Countries

• France

Study Locations