NCT04034407

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

5 years

First QC Date

July 22, 2019

Last Update Submit

July 24, 2019

Conditions

Damage Control for Perforated Diverticulitis

Outcome Measures

Primary Outcomes (1)

  • Reconstructed bowel continuity

    Patients leaving the hospital with complete bowel reconstruction.

    4 weeks

Secondary Outcomes (4)

  • Reconstructed bowel continuity

    6 months

  • Permanent stoma rate

    1 year

  • Mortality rate

    30-days

  • Postoperative complications

    90-days

Study Arms (2)

Damage control surgery

EXPERIMENTAL

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.

Procedure: Damage control surgery

Control group

ACTIVE COMPARATOR

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.

Procedure: Damage control surgery

Interventions

Damage control surgeryPROCEDURE

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.

Control groupDamage control surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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. doi: 10.1007/s11605-012-1977-4. Epub 2012 Jul 28.

    PMID: 22843083BACKGROUND

  • Perathoner A, Klaus A, Muhlmann 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.

    PMID: 20148255BACKGROUND

  • Kafka-Ritsch R, Zitt M, Perathoner A, Gasser E, Kaufman C, Czipin S, Aigner F, Ofner D. Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis with Generalized Peritonitis. World J Surg. 2020 Dec;44(12):4098-4105. doi: 10.1007/s00268-020-05762-1. Epub 2020 Sep 8.

    PMID: 32901323DERIVED

Related Links

Study Officials

  • Reinhold Kafka-Ritsch, Dr.

    Innsbruck Medical University, Dept. of Visceral, Transplant and Thoracic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization to damage control surgery or control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 26, 2019

Study Start

October 14, 2013

Primary Completion

October 14, 2018

Study Completion

October 14, 2018

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share