Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago.
Gennaro Perrone, Mario Giuffrida, Fikri Abu-Zidan...
https://pubmed.ncbi.nlm.nih.gov/38627831Actively Recruiting
Led by Link Campus University · Updated on 2024-06-05
300
Participants Needed
9
Research Sites
21 weeks
Total Duration
This research aims to analyze the potential benefits of damage control surgery, which involves bowel resection, open abdomen, and delayed anastomosis, in treating patients with Hinchey grade III or IV diverticulitis. The study focuses on comparing this approach to other surgical options like the Hartmann procedure and resection with primary anastomosis, particularly in cases of purulent or fecal peritonitis caused by complicated acute large bowel diverticulitis. The treatment being evaluated is Damage Control Surgery, which includes simple resection, dropping the bowel, and leaving the abdomen open temporarily. This approach is considered an alternative to the Hartmann procedure and primary anastomosis, especially in patients with severe sepsis from diverticulitis. The study observes patients who have undergone surgery with this method to describe its rationale and outcomes. Participants in this observational study will be monitored for outcomes such as mortality and morbidity within 60 days after surgery. Researchers will also assess the rate of upfront Hartmann procedures, length of hospital stay, and time spent in the intensive care unit. The study involves follow-up during this 60-day period to understand the effects and potential benefits of Damage Control Surgery in this patient group.
CONDITIONS
Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Acute hospital stay duration
Participants undergo damage control surgery involving resection, clip and drop, and open abdomen techniques for severe acute diverticulitis.
Hospital stay with continuous monitoring
Duration - Up to 60 days
Participants are monitored for mortality, morbidity, and recovery outcomes after surgery.
Follow-up visits as per clinical care for up to 60 days
Total: 9 locations
1
Hospital de Urgencia Asistencia Publica
Santiago, Chile
Enrolling by Invitation
2
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, Italy, 00128
Actively Recruiting
3
UOC Chirurgia Generale - Ospedale GB Grassi
Ostia Antica, Roma, Italy, 00122
Actively Recruiting
4
UOC Chirurgia Generale Ospedale Coniugi Bernardini
Palestrina, Roma, Italy, 00036
Actively Recruiting
5
UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano
Caserta, Italy, 81100
Actively Recruiting
6
UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital
Pisa, Italy, 56124
Actively Recruiting
7
Fondazione Policlinico Universitario "A.Gemelli"
Roma, Italy, 00168
Actively Recruiting
8
UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia
Roma, Italy, 00193
Actively Recruiting
9
Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma
Roma, Italy
Actively Recruiting
G
Gianluca Costa, Prof.
G
Giuseppina Catanzaro, Prof.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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