Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis

Damage Control for Perforated Diverticulitis Clinical Trial

— Damage Control  

Official title:

Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034407
• Other study ID #: Version 1.03
• Status: Completed
• Phase: N/A
• Start date: October 14, 2013
• Est. completion date: October 14, 2018

Study information

• Verified date: July 2019
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 14, 2018
• Est. primary completion date: October 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Damage Control for Perforated Diverticulitis
• Diverticulitis
• Peritonitis

Intervention

Procedure:
• Damage control surgery
All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study. Randomisation was performed intraoperatively in all patients after the performing surgeon confirmed a colonic perforation with generalized peritonitis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

References & Publications (2)

Kafka-Ritsch R, Birkfellner F, Perathoner A, Raab H, Nehoda H, Pratschke J, Zitt M. Damage control surgery with abdominal vacuum and delayed bowel reconstruction in patients with perforated diverticulitis Hinchey III/IV. J Gastrointest Surg. 2012 Oct;16(10):1915-22. Epub 2012 Jul 28. — View Citation

Perathoner A, Klaus A, Mühlmann G, Oberwalder M, Margreiter R, Kafka-Ritsch R. Damage control with abdominal vacuum therapy (VAC) to manage perforated diverticulitis with advanced generalized peritonitis--a proof of concept. Int J Colorectal Dis. 2010 Jun;25(6):767-74. doi: 10.1007/s00384-010-0887-8. Epub 2010 Feb 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reconstructed bowel continuity	Patients leaving the hospital with complete bowel reconstruction.	4 weeks
Secondary	Reconstructed bowel continuity		6 months
Secondary	Permanent stoma rate	Patients with permanent colostomy.	1 year
Secondary	Mortality rate		30-days
Secondary	Postoperative complications	Any complication during hospital stay	90-days

External Links

•   Clinical Trial Registry of the Tirol Kliniken GmbH