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Perforated DiverticulitisNCT04220840

The Damage Control Strategy for the Treatment of Perforated Diverticulitis of the Sigmoid Colon With Diffuse Peritonitis

An observational study of Perforated Diverticulitis, run by Städtisches Klinikum München GmbH at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The best approach for the treatment of perforated diverticulitis of the sigmoid colon is still under debate. Concurrent techniques are 1) resection with primary colorectal anastomosis with or without additional loop ileostomy; 2) end colostomy (Hartmann´s procedure); 3) Damage control strategy; 4) laparoscopic lavage… Read more about this study

Who is it for?
Any age
Conditions the study is for
Perforated Diverticulitis
How many people
600 participants
Where
1 siteGermany
Study dates
1 Nov 2020to 1 Jun 2024
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All consecutive patients who underwent surgery for perforated diverticulitis of the sigmoid colon with generalized peritonitis will be included into the analysis

Who may be able to join

  • all patients who were operated for perforated diverticulitis with generalized peritonitis

Who cannot join

  • incomplete data sets

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting
  • Dr. Maximilian Sohn

    Munich, Bavaria, 81925

    Maximilian Sohn, M.D., Dr. med., +49-89-9270702756, maximilian.sohn@klinikum-muenchen.de

    Igors Iesalnieks, M.D., Prof. Dr. med., +49-9270702125, igors.iesalnieks@klinikum-muenchen.de

    Recruiting

Other trials in Germany

About this study

Official title: The Damage Control Strategy for the Treatment of Perforated Diverticulitis of the Sigmoid Colon With Diffuse Peritonitis - a Retrospective, Multicenter, Transnational Cohort Study

The best approach for the treatment of perforated diverticulitis of the sigmoid colon is still under debate. Concurrent techniques are 1) resection with primary colorectal anastomosis with or without additional loop ileostomy; 2) end colostomy (Hartmann´s procedure); 3) Damage control strategy; 4) laparoscopic lavage and placement of a drainage. It is hypothesized, that the use of the damage control strategy leads to a significant reduction of the stoma rate.

The damage control strategy constitutes a two stage procedure.

Read more

Emergency surgery:

limited resection of the diseased colonic segment with oral and aboral blind closure, abdominal lavage, temporary vacuum assisted abdominal closure

Second look surgery (48-72 hours later):

Reexploration with

  1. definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
  2. lavage, vacuum assisted abdominal closure, third look 72 hours after emergency surgery

Within the study, data of DCS-procedures will be collected retrospectively in a multicentric and transnational approach. Those will be compared to a cohort of patients treated with a "no-DCS"-technique (resection with primary anastomosis or Hartmann´s procedure).

Read the detailed description

Research question/objective of the study

It is assumed that the application of the Damage Control Strategy (DCS) in patients with perforated diverticulitis of the sigmoid colon with generalized peritonitis leads to a reduction of the stoma rate with the same degree of safety as other procedures (Hartmann´ procedure, sigmoid resection with primary anastomosis, laparoscopic lavage).

Definitions

The damage control strategy constitutes a two stage procedure.

Emergency surgery:

limited resection of the diseased colonic segment with oral and aboral blind closure, abdominal lavage, temporary vacuum assisted abdominal closure

Second look surgery (48-72 hours later):

Reexploration with

  1. definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
  2. lavage, vacuum assisted abdominal closure, third look 72 hours after emergency surgery

Basis and scientific knowledge

The majority of patients with acute diverticulitis of the left colon are currently treated conservatively. However, diverticular perforation with diffuse peritonitis remains a challenging and life-threatening situation requiring emergency surgical intervention. Regardless of the frequency and severity of the disease, there is yet no generally accepted treatment algorithm. Sigmoid resection with blind closure of the rectal stump and formation of an end colostomy (Hartmann´s procedure) as well as sigmoid resection with primary anastomosis with or without additional loop ileostomy are alternative procedures. As an additional approach, laparoscopic lavage and drainage has not yet been widely established. Accordingly, the technique is not recommended in the current German S2K guidelines for the treatment of diverticular disease. Within Damage Control Strategy (DCS), a limited resection of the affected sigmoid segment with oral and aboral blind closure is performed during the initial intervention. After abdominal lavage, a temporary vacuum-assisted closure of the abdominal cavity is then performed. 24 to 72 hours later, the decision on the definite reconstruction procedure is made within the scope of the planned second-look laparotomy. Generally, a colorectal anastomosis with or without loop ileostomy is intended. If this is not possible, end colostomy is available as additional option. Principal criteria for the decision on the type of definite reconstruction are the local and general findings of the patient. According to the results of a first cohort from the Innsbruck University Hospital, a colorectal anastomosis can be achieved in almost 80% of patients within second operation. In about half of the patients, a loop ileostomy is additionally created. Using DCS, morbidity and mortality are comparable to the above mentioned competing procedures. An own study from 2016 shows similar results. After the initial hospital stay, 47% of the patients were stoma carriers after the application of DCS, compared to 83% of the patients from the control group to which all "other" surgical procedures (Hartmann operation, Primary anastomosis with or without loop ileostoma) were assigned. At the end of follow-up, 88% of patients were stoma-free after use of DCS. The mortality rate was 11 percent. A systematic review of the available specific literature on DCS is yet underway. The manuscript is currently undergoing peer review at the World Journal of Gastroenterology. In the course of this process the above mentioned results could be confirmed. A total of eight publications from five study groups were identified (status 11/2019). In 73% of the cases a colorectal anastomosis could be performed during the second-look laparotomy. 15% of the patients additionally received a loop ileostomy. End colostomy (secondary Hartmann´s procedure) was necessary in only 27% of the patients. The cumulative anastomotic leak rate was 13%, surgical morbidity 31% and 30-day mortality was 9%. A stoma rate of 45% at discharge should be emphasized. Thus, the number of patients in whom intestinal continuity could be restored during the initial hospital stay was considerably higher when using the damage control strategy than in most studies on the treatment of perforated diverticulitis with diffuse peritonitis. In addition, a stoma rate of <50% at discharge was achieved. These aspects should be highlighted as key benefits. Further positive aspects of the method are the fast and technically simple focus repair during the initial intervention.

Being tested
Damage control strategy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Damage control strategyProcedure or surgery

    The damage control strategy constitutes a two stage procedure.

    Emergency surgery:

    limited resection oft he diseased colonic segment with oral and aboral blind closure, abdominal lavage, temporary vacuum assisted abdominal closure

    Second look surgery (48-72 hours later):

    reexploration with

    1. definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
    2. lavage, vacuum assisted abdominal closure, third look 72 hours after emergency surgery
Study groups in NCT04220840
Study groupRoleWhat they receive
Study GroupAll consecutive patients who underwent damage control surgery (DCS) for perforated diverticulitis of the sigmoid colon with generalized Peritonitis in one of the participating centers
Receives: Procedure: Damage control strategy
Control groupAll consecutive patients who underwent other than DCS surgery (resection with primary anastomosis, Hartmann´s procedure, laparoscopic lavage) for perforated diverticulitis of the sigmoid colon with generalized Peritonitis in one of the participating centers which do not apply DCS routinely.
Receives: Procedure: Damage control strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stoma rate at the end of the index hospital stay

    rate of enterostomies (Loop ileostomy and end colostomy) at the end of the hospital stay, associated to the emergency operation

    Measured: 30 days after surgery for definite reconstruction

Secondary outcomes (3)
  1. Stoma rate over the long term

    rate of enterostomies (Loop ileostomy and end colostomy) at the end of the follow-up

    Measured: through study completion, an average of 1 year

  2. 30-day Morbidity

    Morbidity assessed by the Clavien-Dindo classification

    Measured: 30 days after surgery for definite reconstruction

  3. 30-day Mortality

    Mortality

    Measured: 30 days after surgery for definite reconstruction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2020
  2. Study start1 Nov 2020
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04220840
Sponsor's protocol ID
DCS-INT-2020
Status last verified
Sep 2023
First submitted
3 Jan 2020
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sohn M, Iesalnieks I, Agha A, Steiner P, Hochrein A, Pratschke J, Ritschl P, Aigner F. Perforated Diverticulitis with Generalized Peritonitis: Low Stoma Rate Using a "Damage Control Strategy". World J Surg. 2018 Oct;42(10):3189-3195. doi: 10.1007/s00268-018-4585-y.

    PubMed 29541823
  • Sohn MA, Agha A, Steiner P, Hochrein A, Komm M, Ruppert R, Ritschl P, Aigner F, Iesalnieks I. Damage control surgery in perforated diverticulitis: ongoing peritonitis at second surgery predicts a worse outcome. Int J Colorectal Dis. 2018 Jul;33(7):871-878. doi: 10.1007/s00384-018-3025-7. Epub 2018 Mar 13.

    PubMed 29536238
  • Sohn M, Agha A, Heitland W, Gundling F, Steiner P, Iesalnieks I. Damage control strategy for the treatment of perforated diverticulitis with generalized peritonitis. Tech Coloproctol. 2016 Aug;20(8):577-83. doi: 10.1007/s10151-016-1506-7. Epub 2016 Jul 22.

    PubMed 27448296
  • 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 22843083

Questions about this trial

What is this clinical trial studying?

An observational study of Perforated Diverticulitis, run by Städtisches Klinikum München GmbH at 1 site in Germany.

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 1 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stoma rate at the end of the index hospital stay (time frame: 30 days after surgery for definite reconstruction). 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 NCT04220840, which also lists 4 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 8 Sep 2023.

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