Trial on Damage Control Surgery for Perforated Diverticulitis With Generalized Peritonitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-14

Study Completion Date

2018-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

NCT01239927

Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

COMPLETED PHASE2/PHASE3

Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis

NCT01317485

Perforated Diverticulitis

UNKNOWN PHASE3

Damage Control Surgery in the Treatment of Complicated Diverticulitis

NCT03337984

Diverticulitis

COMPLETED

Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis

NCT03994978

Diverticulitis of Sigmoid

COMPLETED

Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery

NCT01837342

Peritonitis Diverticulitis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Damage Control for Perforated Diverticulitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization to damage control surgery or control group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Damage control surgery

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.

Group Type EXPERIMENTAL

Damage control surgery

Intervention Type PROCEDURE

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.

Control group

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.

Group Type ACTIVE_COMPARATOR

Damage control surgery

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Damage control surgery

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No