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RecruitingNCT04220840Updated Sep 8, 2023

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

An observational study in Perforated Diverticulitis, sponsored by Städtisches Klinikum München GmbH. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Städtisches Klinikum München GmbH · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2020; still recruiting 6 years later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
600
Sex
All
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Study 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 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.

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.

02

Conditions studied

  • Perforated Diverticulitis

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03

In context

Diverticulitis

125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.

This study's planned enrollment of 600 is above the median of 275 across 59 observational studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Städtisches Klinikum München GmbH is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

all patients who were operated for perforated diverticulitis with generalized peritonitis

Exclusion criteria

Exclusion Criteria:

incomplete data sets

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study Group

    All consecutive patients who underwent damage control surgery (DCS) for perforated diverticulitis of the sigmoid colon with generalized Peritonitis in one of the participating centers

    Procedure: Damage control strategy

  • Control group

    All 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.

    Procedure: Damage control strategy

Interventions

  • ProcedureDamage control strategy

    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

06

What researchers measure

Primary outcomes

  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

    Time frame: 30 days after surgery for definite reconstruction

Secondary outcomes

  1. Stoma rate over the long term

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

    Time frame: through study completion, an average of 1 year

  2. 30-day Morbidity

    Morbidity assessed by the Clavien-Dindo classification

    Time frame: 30 days after surgery for definite reconstruction

  3. 30-day Mortality

    Mortality

    Time frame: 30 days after surgery for definite reconstruction

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Study locations

1 of 1 sites recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2020 (actual). Primary completion is estimated for Dec 2023, 37 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2020
First posted
Jan 7, 2020
StartActual
Nov 1, 2020
Primary completionEst.
Dec 1, 2023
CompletionEst.
Jun 1, 2024
Last update
Sep 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04220840
Lead sponsor
Städtisches Klinikum München GmbH
Responsible party
Dr. Maximilian Sohn (M.D., Dr. med., Attending Surgeon, Städtisches Klinikum München GmbH) — Principal investigator
First posted
Jan 7, 2020
Start date
Nov 1, 2020
Primary completion
Dec 1, 2023 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Sep 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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