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)

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.

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 Overview

• Status: Unknown
• Conditions: Diverticulitis; Peritonitis
• Intervention / Treatment: Procedure: Surgical reserction; Other: Radiological percutaneous drainage and washing drainage

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 26, 2012
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 17, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Intraabdominal Infections; Peritonitis; Diverticulitis
• Other Study ID Numbers: 5061