Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis

NCT03932461 | Recruiting DMC FDA Device

• 1 other identifier: VACOR2019
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".

Conditions

Fecal Peritonitis; Secondary Peritonitis; Diffuse; Peritonitis

Outcome Measures

Primary Outcomes (1)

• Primary endpoint is to compare peritonitis related complications and Comprehensive Complication Index (CCI) between NPWT treatment (VAC) and conventional treatment (ROD) at 30, 90 days and 1 year.

  Disease-Related Major Morbidity Needing Readmission and Conservative Treatment but Not Surgery * Fistula * Wound dehiscence/incisional hernia with obstruction * Abscess needing percutaneous drainage * Renal failure * Myocardial infarction * Gastric or duodenal bleeding * Respiratory failure * Urosepsis Disease-Related Major Morbidity Needing Surgical Intervention During First Admission or Readmission * Incisional hernia * Bowel obstruction or herniation due to intra-abdominal adhesions * Burst abdomen * Abdominal compartment syndrome * Fistula * Intra-abdominal bleeding * Intra-abdominal hematoma needing surgical evacuation * Perforation of visceral organ confirmed at surgery * Anastomotic leakage * Ischemia or necrosis of a visceral organ * Enterostomy dysfunction due to prolapse, stenosis, or retraction * Gastric or duodenal ulcer bleeding needing intervention of any type

  1 year

Secondary Outcomes (4)

• Mortality at 30, 90 days and 1 year

  1 year

• Quality of life after treatment

  3 and 12 months

• Ventral hernia rate

  3 and 12 months

• Hospital care utility within three months after index surgery

  Up to 12 weeks

Other Outcomes (2)

• Microdialysis

  First 4 days afte index laparatomy

• Inscional hernia

  3 years

Study Arms (2)

Vacuum assisted closure

ACTIVE COMPARATOR

The VAC® Abdominal Dressing System (KCI Vacuum Assisted Closure, San Antonio, TX, USA) will be used. Intestines, including lateral aspects, are covered by the visceral protective layer. The first layer of foam is placed in the laparostoma on the visceral protective layer and must extend below the fascia at a distance of 5 cm from the facial opening. Above this, a minimum of one piece of foam is folded and placed in the laparostoma. Finally, the laparostoma will be covered by the occlusive drape. A circular opening of approximately 5 cm in diameter will be created in the drape where the connection tubes to the vacuum pump will be placed. Simultaneously while applying the negative pressure of 125 mmHg, the wound edges are approximated manually towards the midline. Each dressing change must be performed in the operation theatre with the patient in general anesthesia and muscle relaxation.

Procedure: Vacuum assisted closure

Relaparotomy "on-demand"

ACTIVE COMPARATOR

The Isreaelsson principle includes a running suture of the fascia with a distance of 5 mm between the stitches of 5 mm and the distance to the facial edge of 5-10 mm. Monofilament PDS 2-0 or equivalent is used. The suturing is started cranially and caudally, and the sutures are tied with self-locking knots. Four times as much suture material as the length of the wound must be used. The peritoneal fluid must be cultured at closure. The treating surgeon decides to perform a ROD and should be guided by the patient's general condition, gastrointestinal function, renal function, and inflammatory parameters at daily rounds.

Procedure: Relaparotomy "on demand"

Interventions

Vacuum assisted closure PROCEDURE

The Vacuum assisted closure system consists of an abdominal dressing covering the intra abdominal viscera over the dressing there will be placed a blue sponge which will be covered by drape and connected to a vacuum pump.

Also known as: VAC® Abdominal Dressing System, KCI, (San Antonio, TX)

Vacuum assisted closure

Relaparotomy "on demand" PROCEDURE

Abdomen is closed at the index operation after source of peritonitis is treated. Every 48-hours the patients are evaluated for the need of relaparotomy based on clinical and paraclinical parameters.

Relaparotomy "on-demand"

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for enrolment are 18+ years of age and are scheduled for acute laparotomy due to suspected peritonitis originating from perforation of the small bowel, colon, or rectum. To be included, purulent, enteric, or fecal contamination in a minimum of 2 out of 4 quadrants must be confirmed.

You may not qualify if:

• Diffuse peritonitis originating from a different focus than the small intestine, colon or rectum
• Diffuse peritonitis originating from a perforation on the stomach, duodenum, gallbladder, appendix, necrotizing pancreatitis, salpingitis, or peritoneal dialysis
• Primary peritonitis
• Immunocompromised (ongoing chemotherapy or prednisolone \>20 mg/day)
• Chronic parenchymal liver disease
• Pregnancy
• Patients with end-stage disease
• Laparoscopic surgery (not converted to laparotomy)
• Acute occlusion of superior mesenteric artery
• Peritoneal carcinomatosis
• Abdominal trauma
• Lack of consent from the surgical equipoise
• Local peritonitis confined to 1 quadrant only

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

RECRUITING

Related Publications (1)

• Rajabaleyan P, Michelsen J, Tange Holst U, Moller S, Toft P, Luxhoi J, Buyukuslu M, Bohm AM, Borly L, Sandblom G, Kobborg M, Aagaard Poulsen K, Schou Love U, Ovesen S, Grant Solling C, Morch Sondergaard B, Lund Lomholt M, Ritz Moller D, Qvist N, Bremholm Ellebaek M; VACOR study group. Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis-the VACOR trial: protocol for a randomised controlled trial. World J Emerg Surg. 2022 May 26;17(1):25. doi: 10.1186/s13017-022-00427-x.

  PMID: 35619144 DERIVED

MeSH Terms

Conditions

Peritonitis

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Niels Qvist, Professor

  Surgical Department A, Odense University Hospital, Denmark

  STUDY DIRECTOR

• Uffe Tange Holst, M.D.

  Surgical Department A, Odense University Hospital, Denmark

  STUDY CHAIR

• Jens Michelsen, M.D.

  Anesthesiology department V, Odense University Hospital, Denmark

  STUDY CHAIR

• Palle Toft, Professor

  Anesthesiology department V, Odense University Hospital, Denmark

  STUDY CHAIR

Central Study Contacts

Pooya Rajabaleyan, M.D.

CONTACT

+4527118889; pooya.r@hotmail.com

Mark Ellebæk, M.D., Ph.d.

CONTACT

+4540880511; markep01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Multicentre randomized non-blinded clinical trial comprising of \> 4 centres. In total there will be included 320 patients.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 30, 2019
• Study Start: June 1, 2020
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)