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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04034407
Other study ID # Version 1.03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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