Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis

Not Applicable

Completed

• Conditions: Damage Control for Perforated Diverticulitis
• Interventions: Procedure: Damage control surgery

• Registration Number: NCT04034407
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study Start: 2013-10-14
• Primary Completion: 2018-10-14
• Study Completion: 2018-10-14
• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 and intraoperatively confirmed generalized peritonitis

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Damage control surgery	Damage control surgery	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.
Control group	Damage control surgery	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.

Primary Outcome Measures

Name	Time	Method
Reconstructed bowel continuity	4 weeks	Patients leaving the hospital with complete bowel reconstruction.

Secondary Outcome Measures

Name	Time	Method
Reconstructed bowel continuity	6 months
Permanent stoma rate	1 year	Patients with permanent colostomy.
Mortality rate	30-days
Postoperative complications	90-days	Any complication during hospital stay