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 (SIGMOIDITE)

This study is currently recruiting participants.
Verified April 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01837342
First received: November 26, 2012
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Peritonitis
Diverticulitis
Procedure: Surgical reserction
Other: Radiological percutaneous drainage and washing drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sigmoidectomy arm
Standard of care arm : sigmoid reserction after randomisation
Procedure: Surgical reserction
Experimental: Control arm
laproscopic drainage and washing
Other: Radiological percutaneous drainage and washing drainage

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837342

Contacts
Contact: Cécile BRIGAND, MD, PHD 03 88 12 72 26 Cecile.brigand@chru-strasbourg.fr

Locations
France
Chirurgie générale et digestive,Hôpital de Hautepierre, Not yet recruiting
Strasbourg, Alsace, France, 67098
Contact: Cécile BRIGAND, MD, PDH    03 88 12 72 26    Cecile.brigand@chru-strasbourg.fr   
Principal Investigator: Cécile Brigand, MD,PHD         
Clinique Universitaire de Chirurgie Digestive et de l'Urgence Not yet recruiting
Grenoble, CHU de Grenoble, France, BP 217
Contact: Catherine ARVIEUX, MD, PHD    04 76 76 92 80    carvieux@chu-grenoble.fr   
Chirurgie générale et digestive,Hôpital de Hautepierre, Recruiting
Hôpital de Hautepierre, STRASBOURG cedex, France, 67098
Principal Investigator: BRIGAND Cécile, MD         
CHU Amiens Nord Place Victor Pauchet Not yet recruiting
Amiens, France, 80054
Principal Investigator: Jean Marc REGIMBEAU, MD         
Service de chirurgie digestive Hotel Dieu Not yet recruiting
Clermont ferrand, France, 63058
Principal Investigator: Karim SLIM, MD,PHD         
Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers Not yet recruiting
Colombes, France, 92700
Principal Investigator: Simon MSIKA, MD         
chirurgie digestive et générale, Hôpital C Huriez Place de Verdun Not yet recruiting
Lille, France
Principal Investigator: Christophe MARIETTE, MD, PHD         
Service de chirurgie digestiveCentre Hospitalier Bretagne Sud Not yet recruiting
Lorient, France, 56100
Contact: David GUINIER, MD    02 97 64 90 00    d.guinier@ch-bretagne-sud.fr   
Principal Investigator: David GUINIER, MD         
Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec Not yet recruiting
Mulhouse, France, 68100
Contact: DAN Sébastien, MD    0389647339    dans@ch-mulhouse.fr   
Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré Not yet recruiting
Paris, France, 75475 Paris cedex 10
Principal Investigator: Marc POCARD, MD         
Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière Not yet recruiting
Paris, France
Contact: Mehdi KAROUI, MD         
Principal Investigator: David GUINIER, MD         
Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054 Not yet recruiting
Toulouse, France
Principal Investigator: Fabrice MUSCARI, MD         
Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire Not yet recruiting
Toulouse, France
Principal Investigator: Bertrand SUC, MD         
Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, Not yet recruiting
Vannes, France, 56000
Principal Investigator: Didier RIO, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Catherine ARVIEUX, MD,PHD Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217
Study Chair: Cécile BRIGAND, MD, PHD Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex
Principal Investigator: Sébastien DAN, MD Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec
Principal Investigator: David GUINIER, MD Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 Lorient
Principal Investigator: Mehdi KAROUI, MD Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,Créteil
Principal Investigator: Christophe MARIETTE, MD,PHD chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille Cedex
Principal Investigator: MSIKA Simon, MD Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 Colombes
Principal Investigator: MUSCARI Fabrice, MD, PHD Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 - TOULOUSE CEDEX
Principal Investigator: Marc POCARD, MD, PHD Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10
Principal Investigator: REGIMBEAU Jean Marc, MD CHU Amiens Nord Place Victor, Pauchet 80054 Amiens
Principal Investigator: Didier RIO, MD Service de chirurgie digestive et viscérale, Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, 56000 Vannes
Principal Investigator: Karim SLIM, MD,PHD Service de chirurgie digestive Hotel Dieu, Bd Léon Malfreyt
Principal Investigator: Bertrand SUC, MD Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire de TOULOUSE - RANGUEIL Avenue Jean Poulhes 31054 - TOULOUSE CEDEX
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01837342     History of Changes
Other Study ID Numbers: 5061
Study First Received: November 26, 2012
Last Updated: April 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diverticulitis
Peritonitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on April 16, 2014