Suspended

SIGMOIDITEMulticenter 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.

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What is being tested

Surgical reserction

+ Radiological percutaneous drainage and washing drainage

ProcedureOther
Who is being recruted

Diverticular Diseases+6

+ Digestive System Diseases

+ Gastroenteritis

From 18 to 65 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Strasbourg, France
Study ContactCécile BRIGAND, MD, PHDMore contacts
Last updated: April 23, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity Hospital, Strasbourg, France
Study ContactCécile BRIGAND, MD, PHDMore contacts
Last updated: April 23, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diverticular DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesInfectionsPeritoneal DiseasesIntraabdominal InfectionsDiverticulitisPeritonitis

Criteria

6 inclusion criteria required to participate
Absence of contra-indication for surgery ASA Score <= 3

Male and female individuals aged from 18 to 65 years old (both ages included)

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 must be affiliated with, or a beneficiary of a social security system

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9 exclusion criteria prevent from participating
ASA Score > 3

Contra- indication to surgery

Past history of evolutive neoplasm

Patients for which consultation visits will not be possible (e.g. tourists and people who cannot stay above 18 months in France)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Standard of care arm : sigmoid reserction after randomisation

Group II

Experimental
laproscopic drainage and washing

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Recruiting

Chirurgie générale et digestive,Hôpital de Hautepierre,

Hôpital de Hautepierre, FranceOpen Chirurgie générale et digestive,Hôpital de Hautepierre, in Google Maps
Recruiting soon

Chirurgie générale et digestive,Hôpital de Hautepierre,

Strasbourg, France
Recruiting soon

Clinique Universitaire de Chirurgie Digestive et de l'Urgence

Grenoble, France
Recruiting soon

Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec

Mulhouse, France
Suspended14 Study Centers