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

• ClinicalTrials.gov Identifier: NCT04220840
• Recruitment Status: Recruiting
• First Posted: January 7, 2020
• Last Update Posted: September 8, 2023
• Sponsor: Städtisches Klinikum München GmbH
• Collaborators: Charite University, Berlin, Germany; Medical University Innsbruck; University of Pisa; Cardarelli Hospital
• Information provided by (Responsible Party): Dr. Maximilian Sohn, Städtisches Klinikum München GmbH

Tracking Information

• First Submitted Date: January 3, 2020
• First Posted Date: January 7, 2020
• Last Update Posted Date: September 8, 2023
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 5, 2020)

• Stoma rate over the long term [ Time Frame: through study completion, an average of 1 year ]
  rate of enterostomies (Loop ileostomy and end colostomy) at the end of the follow-up
• 30-day Morbidity [ Time Frame: 30 days after surgery for definite reconstruction ]
  Morbidity assessed by the Clavien-Dindo classification
• 30-day Mortality [ Time Frame: 30 days after surgery for definite reconstruction ]
  Mortality

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Damage Control Strategy for the Treatment of Perforated Diverticulitis of the Sigmoid Colon With Diffuse Peritonitis
• 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

Brief 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).

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Perforated Diverticulitis

Intervention

Procedure: Damage 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

Study Groups/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
  Intervention: 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.
  Intervention: Procedure: Damage control strategy

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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 5, 2020): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2024
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

all patients who were operated for perforated diverticulitis with generalized peritonitis

Exclusion Criteria:

incomplete data sets

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04220840
• Other Study ID Numbers: DCS-INT-2020
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. Maximilian Sohn, Städtisches Klinikum München GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Städtisches Klinikum München GmbH
• Original Study Sponsor: Same as current

Collaborators

• Charite University, Berlin, Germany
• Medical University Innsbruck
• University of Pisa
• Cardarelli Hospital

• Investigators: Not Provided
• PRS Account: Städtisches Klinikum München GmbH
• Verification Date: September 2023