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Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis (Damage Control)

Primary Purpose

Damage Control for Perforated Diverticulitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Damage control surgery
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Damage Control for Perforated Diverticulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study and intraoperatively confirmed generalized peritonitis

Exclusion Criteria:

  • Covered perforation or peritonitis limited to one quadrant
  • No colonic perforation (gastric perforation, appendicitis, ...)
  • Malignancy as cause of perforation
  • Age < 18 years
  • Pregnancy
  • Preoperative anal incontinence
  • No patient consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Damage control surgery

    Control group

    Arm Description

    In the damage control surgery (DCS) group the surgeon was asked to perform rapid source control by stapling the perforated segment leaving blind ends or suturing the perforation site if possible, doing a thorough lavage of the abdominal cavity and placing an intra-abdominal negative pressure system avoiding the retraction of the abdominal wall with dynamic sutures as published. The second-look operation was scheduled for a time 24-48 hours after primary surgery that would be during regular working hours with a colorectal surgeon on hand to make the decision for either anastomosis or ostomy.

    In the conventional treatment group (Group C), the decision to reconstruct the colon or perform a Hartmann procedure was made by the surgeon during the emergency operation. After performing the anastomosis or the Hartmann procedure, patients with advanced peritonitis received an intraabdominal negative pressure system at the discretion of the operating surgeon.

    Outcomes

    Primary Outcome Measures

    Reconstructed bowel continuity
    Patients leaving the hospital with complete bowel reconstruction.

    Secondary Outcome Measures

    Reconstructed bowel continuity
    Permanent stoma rate
    Patients with permanent colostomy.
    Mortality rate
    Postoperative complications
    Any complication during hospital stay

    Full Information

    First Posted
    July 22, 2019
    Last Updated
    July 24, 2019
    Sponsor
    Medical University Innsbruck
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04034407
    Brief Title
    Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis
    Acronym
    Damage Control
    Official Title
    Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 14, 2013 (Actual)
    Primary Completion Date
    October 14, 2018 (Actual)
    Study Completion Date
    October 14, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University Innsbruck

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Damage control surgery (DCS) with abdominal negative pressure therap (NPT) and delayed anastomosis creation in patients with perforated diverticulitis and generalized peritonitis was established at our Institution in 2006 and has been published. This is the first prospectively controlled randomized study comparing DCS with conventional treatment (Group C).
    Detailed Description
    Inclusion criteria: All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study. Exclusion criteria: Covered perforation or peritonitis limited to one quadrant No colonic perforation (gastric perforation, appendicitis, ...) Malignancy as cause of perforation Age < 18 years Pregnancy Preoperative anal incontinence No patient consent Primary endpoint: Reconstructed bowel continuity at discharge and 6 months. Secondary endpoint: Permanent stoma rate 30-day mortality rate Postoperative complications Randomisation was performed intraoperatively in all patients after the performing surgeon confirmed a colonic perforation with generalized Peritonitis. All patients preoperatively granted their consent to participate in the study. Surgical strategy: In the damage control surgery (DCS) group the surgeon was asked to perform rapid source control by stapling the perforated segment leaving blind ends or suturing the perforation site if possible, doing a thorough lavage of the abdominal cavity and placing an intra-abdominal negative pressure system avoiding the retraction of the abdominal wall with dynamic sutures as published. The second-look operation was scheduled for a time 24-48 hours after primary surgery that would be during regular working hours with a colorectal surgeon on hand to make the decision for either anastomosis or ostomy. In the conventional treatment group (Group C), the decision to reconstruct the colon or perform a Hartmann procedure was made by the surgeon during the emergency operation. After performing the anastomosis or the Hartmann procedure, patients with advanced peritonitis received an intraabdominal negative pressure system at the discretion of the operating surgeon. Data collection and statistics: Data were collected by our study nurse, who visited the patients, and statistical calculations were performed with SPSS 20. Assuming a reconstruction rate of 80% in the study group and 50% in the conventional treatment group, we calculated that 70 patients would be needed to prove our hypothesis. Statistical calculation was performed with Chi-square for distribution of clinical data and stoma rate and the Mann-Whitney U test was used to compare numeric and nonparametric data. The study was approved by our local ethics committee (EC No.: UN5157).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Damage Control for Perforated Diverticulitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    1:1 randomization to damage control surgery or control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Damage control surgery
    Arm Type
    Experimental
    Arm Description
    In the damage control surgery (DCS) group the surgeon was asked to perform rapid source control by stapling the perforated segment leaving blind ends or suturing the perforation site if possible, doing a thorough lavage of the abdominal cavity and placing an intra-abdominal negative pressure system avoiding the retraction of the abdominal wall with dynamic sutures as published. The second-look operation was scheduled for a time 24-48 hours after primary surgery that would be during regular working hours with a colorectal surgeon on hand to make the decision for either anastomosis or ostomy.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    In the conventional treatment group (Group C), the decision to reconstruct the colon or perform a Hartmann procedure was made by the surgeon during the emergency operation. After performing the anastomosis or the Hartmann procedure, patients with advanced peritonitis received an intraabdominal negative pressure system at the discretion of the operating surgeon.
    Intervention Type
    Procedure
    Intervention Name(s)
    Damage control surgery
    Intervention Description
    All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study. Randomisation was performed intraoperatively in all patients after the performing surgeon confirmed a colonic perforation with generalized peritonitis.
    Primary Outcome Measure Information:
    Title
    Reconstructed bowel continuity
    Description
    Patients leaving the hospital with complete bowel reconstruction.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Reconstructed bowel continuity
    Time Frame
    6 months
    Title
    Permanent stoma rate
    Description
    Patients with permanent colostomy.
    Time Frame
    1 year
    Title
    Mortality rate
    Time Frame
    30-days
    Title
    Postoperative complications
    Description
    Any complication during hospital stay
    Time Frame
    90-days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study and intraoperatively confirmed generalized peritonitis Exclusion Criteria: Covered perforation or peritonitis limited to one quadrant No colonic perforation (gastric perforation, appendicitis, ...) Malignancy as cause of perforation Age < 18 years Pregnancy Preoperative anal incontinence No patient consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reinhold Kafka-Ritsch, Dr.
    Organizational Affiliation
    Innsbruck Medical University, Dept. of Visceral, Transplant and Thoracic Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22843083
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20148255
    Citation
    Perathoner A, Klaus A, Muhlmann G, Oberwalder M, Margreiter R, Kafka-Ritsch R. Damage control with abdominal vacuum therapy (VAC) to manage perforated diverticulitis with advanced generalized peritonitis--a proof of concept. Int J Colorectal Dis. 2010 Jun;25(6):767-74. doi: 10.1007/s00384-010-0887-8. Epub 2010 Feb 11.
    Results Reference
    background
    PubMed Identifier
    32901323
    Citation
    Kafka-Ritsch R, Zitt M, Perathoner A, Gasser E, Kaufman C, Czipin S, Aigner F, Ofner D. Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis with Generalized Peritonitis. World J Surg. 2020 Dec;44(12):4098-4105. doi: 10.1007/s00268-020-05762-1. Epub 2020 Sep 8.
    Results Reference
    derived
    Links:
    URL
    https://ctc.tirol-kliniken.at/page.cfm?vpath=oeffentliche&action=viewdetail&studie=6411
    Description
    Clinical Trial Registry of the Tirol Kliniken GmbH

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    Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis

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