Damage Control for Perforated Diverticulitis Clinical Trial
Official title:
Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis
Damage control surgery (DCS) with abdominal negative pressure therap (NPT) and delayed anastomosis creation in patients with perforated diverticulitis and generalized peritonitis was established at our Institution in 2006 and has been published. This is the first prospectively controlled randomized study comparing DCS with conventional treatment (Group C).
Inclusion criteria:
All patients with clinical and radiological suspicion of colonic perforation and generalized
Peritonitis with indication for emergency surgery were included in the study.
Exclusion criteria:
- Covered perforation or peritonitis limited to one quadrant
- No colonic perforation (gastric perforation, appendicitis, ...)
- Malignancy as cause of perforation
- Age < 18 years
- Pregnancy
- Preoperative anal incontinence
- No patient consent
Primary endpoint:
Reconstructed bowel continuity at discharge and 6 months.
Secondary endpoint:
- Permanent stoma rate
- 30-day mortality rate
- Postoperative complications
Randomisation was performed intraoperatively in all patients after the performing surgeon
confirmed a colonic perforation with generalized Peritonitis. All patients preoperatively
granted their consent to participate in the study.
Surgical strategy:
In the damage control surgery (DCS) group the surgeon was asked to perform rapid source
control by stapling the perforated segment leaving blind ends or suturing the perforation
site if possible, doing a thorough lavage of the abdominal cavity and placing an
intra-abdominal negative pressure system avoiding the retraction of the abdominal wall with
dynamic sutures as published. The second-look operation was scheduled for a time 24-48 hours
after primary surgery that would be during regular working hours with a colorectal surgeon on
hand to make the decision for either anastomosis or ostomy. In the conventional treatment
group (Group C), the decision to reconstruct the colon or perform a Hartmann procedure was
made by the surgeon during the emergency operation. After performing the anastomosis or the
Hartmann procedure, patients with advanced peritonitis received an intraabdominal negative
pressure system at the discretion of the operating surgeon.
Data collection and statistics:
Data were collected by our study nurse, who visited the patients, and statistical
calculations were performed with SPSS 20. Assuming a reconstruction rate of 80% in the study
group and 50% in the conventional treatment group, we calculated that 70 patients would be
needed to prove our hypothesis. Statistical calculation was performed with Chi-square for
distribution of clinical data and stoma rate and the Mann-Whitney U test was used to compare
numeric and nonparametric data. The study was approved by our local ethics committee (EC No.:
UN5157).
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