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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2017

Interventions

  • Procedure: Surgical reserction
  • Other: Radiological percutaneous drainage and washing drainage

Arms, Groups and Cohorts

  • Other: Sigmoidectomy arm
    • Standard of care arm : sigmoid reserction after randomisation
  • Experimental: Control arm
    • laproscopic drainage and washing

Clinical Trial Outcome Measures

Primary Measures

  • Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity
    • Time Frame: 2 years
    • 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 Measures

  • Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients
    • Time Frame: 2 years
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Catherine ARVIEUX, MD,PHD, Principal Investigator, Clinique Universitaire de Chirurgie Digestive et de l’Urgence, CHU de Grenoble, BP 217
    • Cécile BRIGAND, MD, PHD, Study Chair, Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex
    • Sébastien DAN, MD, Principal Investigator, Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec
    • David GUINIER, MD, Principal Investigator, Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 Lorient
    • Mehdi KAROUI, MD, Principal Investigator, Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,Créteil
    • Christophe MARIETTE, MD,PHD, Principal Investigator, chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille Cedex
    • MSIKA Simon, MD, Principal Investigator, Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 Colombes
    • MUSCARI Fabrice, MD, PHD, Principal Investigator, Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 – TOULOUSE CEDEX
    • Marc POCARD, MD, PHD, Principal Investigator, Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10
    • REGIMBEAU Jean Marc, MD, Principal Investigator, CHU Amiens Nord Place Victor, Pauchet 80054 Amiens
    • Didier RIO, MD, Principal Investigator, Service de chirurgie digestive et viscérale, Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, 56000 Vannes
    • Karim SLIM, MD,PHD, Principal Investigator, Service de chirurgie digestive Hotel Dieu, Bd Léon Malfreyt
    • Bertrand SUC, MD, Principal Investigator, Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire de TOULOUSE – RANGUEIL Avenue Jean Poulhes 31054 – TOULOUSE CEDEX
  • Overall Contact(s)
    • Cécile BRIGAND, MD, PHD, 03 88 12 72 26, Cecile.brigand@chru-strasbourg.fr

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