Damage Control for Perforated DiverticulitisDamage ControlNCT04034407
Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis
A study of Damage Control for Perforated Diverticulitis, run by Medical University Innsbruck.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Damage Control for Perforated Diverticulitis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2013to 14 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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).
Read the 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).
- Being tested
- Damage control surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damage control surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Damage control surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstructed bowel continuity
Patients leaving the hospital with complete bowel reconstruction.
Measured: 4 weeks
Secondary outcomes (4)
Reconstructed bowel continuity
Measured: 6 months
Permanent stoma rate
Patients with permanent colostomy.
Measured: 1 year
Mortality rate
Measured: 30-days
Postoperative complications
Any complication during hospital stay
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start14 Oct 2013
- Primary completion14 Oct 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Damage Control for Perforated DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to damage control surgery or control group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinhold Kafka-Ritsch, Dr., Principal investigator, Innsbruck Medical University, Dept. of Visceral, Transplant and Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034407
- Sponsor's protocol ID
- Version 1.03
- Acronym
- Damage Control
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22843083Perathoner 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.
PubMed 20148255Kafka-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.
PubMed 32901323
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis
- ClinicalTrials.gov ID
- NCT04034407
- Acronym / sponsor ID
- Damage Control / Version 1.03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 14 Oct 2013 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to damage control surgery or control group
| Arm | Type | Receives |
|---|---|---|
| Damage control surgery | Experimental | Procedure: Damage control surgeryIn 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 | Active comparator | Procedure: Damage control surgeryIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- Covered perforation or peritonitis limited to one quadrant
- No colonic perforation (gastric perforation, appendicitis, ...)
- Malignancy as cause of perforation
- Age < 18 years
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damage control surgeryAll 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. | Procedure or surgery | Control group, Damage control surgery |
Primary outcome
Reconstructed bowel continuity
Time frame: 4 weeks
Patients leaving the hospital with complete bowel reconstruction.
4 secondary outcomes
Reconstructed bowel continuity
Time frame: 6 months
Permanent stoma rate
Time frame: 1 year
Mortality rate
Time frame: 30-days
Postoperative complications
Time frame: 90-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Background: PubMed 22843083Kafka-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.
- Background: PubMed 20148255Perathoner 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.
- Derived from this study: PubMed 32901323Kafka-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.
- Clinical Trial Registry of the Tirol Kliniken GmbHLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinhold Kafka-Ritsch, Dr. principal investigator
Innsbruck Medical University, Dept. of Visceral, Transplant and Thoracic Surgery
Questions about this trial
What is this clinical trial studying?
A study of Damage Control for Perforated Diverticulitis, run by Medical University Innsbruck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reconstructed bowel continuity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04034407, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.