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

NCT04220840 | Unknown

• 1 other identifier: DCS-INT-2020
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Perforated Diverticulitis

Outcome Measures

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

  30 days after surgery for definite reconstruction

Secondary Outcomes (3)

• Stoma rate over the long term

  through study completion, an average of 1 year

• 30-day Morbidity

  30 days after surgery for definite reconstruction

• 30-day Mortality

  30 days after surgery for definite reconstruction

Study Arms (2)

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

Damage control strategy PROCEDURE

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

Control group; Study Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• incomplete data sets

Sponsors & Collaborators

• Städtisches Klinikum München GmbH: lead
• Charite University, Berlin, Germany: collaborator
• Medical University Innsbruck: collaborator
• University of Pisa: collaborator
• Cardarelli Hospital: collaborator

Study Sites (1)

Dr. Maximilian Sohn

Munich, Bavaria, 81925, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 29541823 RESULT

• 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.

  PMID: 29536238 RESULT

• 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.

  PMID: 27448296 RESULT

• 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.

  PMID: 22843083 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Dr. med., Attending Surgeon

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)