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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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
- 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
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
- definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
- 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
- definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
- 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.
- Conditions
- Perforated Diverticulitis
- 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
- definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
- lavage, vacuum assisted abdominal closure, third look 72 hours after emergency surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Damage control strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
30-day Morbidity
Morbidity assessed by the Clavien-Dindo classification
Measured: 30 days after surgery for definite reconstruction
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.
- First posted7 Jan 2020
- Study start1 Nov 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Städtisches Klinikum München GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Medical University Innsbruck, University of Pisa, Cardarelli Hospital
- Responsible party
- Principal investigator, Dr. Maximilian Sohn, Städtisches Klinikum München GmbH
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 29541823Sohn 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 29536238Sohn 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 27448296Kafka-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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04220840
- Acronym / sponsor ID
- DCS-INT-2020
- Conditions
- Perforated Diverticulitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Städtisches Klinikum München GmbHUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Medical University Innsbruck, University of Pisa, Cardarelli Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 7 Jan 2020 (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.
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
- definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
- 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).
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
- definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: Damage control strategyAll consecutive patients who underwent damage control surgery (DCS) for perforated diverticulitis of the sigmoid colon with generalized Peritonitis in one of the participating centers |
| Control group | – | Procedure: Damage control strategyAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- all patients who were operated for perforated diverticulitis with generalized peritonitis
Key exclusion criteria (1 listed)
- incomplete data sets
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 strategyThe 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 | Procedure or surgery | Control group, Study Group |
Primary outcome
Stoma rate at the end of the index hospital stay
Time frame: 30 days after surgery for definite reconstruction
rate of enterostomies (Loop ileostomy and end colostomy) at the end of the hospital stay, associated to the emergency operation
3 secondary outcomes
Stoma rate over the long term
Time frame: through study completion, an average of 1 year
30-day Morbidity
Time frame: 30 days after surgery for definite reconstruction
30-day Mortality
Time frame: 30 days after surgery for definite reconstruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Results publication: PubMed 29541823Sohn 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.
- Results publication: PubMed 29536238Sohn 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.
- Results publication: PubMed 27448296Sohn 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.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
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.