Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

NCT ID: NCT03293862

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-02-28

Brief Summary

Facial dehiscence elicit high morbidity and mortality. This complication may arise in more than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on the incidence of fascial dehiscence in emergency surgery and associated complications.

Detailed Description

Fascial dehiscence is associated with high morbidity and mortality rates. It occurs in more than 8.5% of high-risk patients. Current preventive measures described are control of risk factors and optimization of surgical technique. Despite that, the incidence of such complication remained stable in the last decades, highlighting the low efficacy of such measures. Polypropilene onlay mesh has been used to avoid incisional hernias in selected elective patients, and could be useful in the prevention of fascial dehiscence. In emergency situations, especially in contaminated and infected surgical procedures, safety and efficacy of mesh is controversial. In this study the investigators aimed to evaluate the influence of polypropilene prophylactic onlay mesh on the incidence of fascial dehiscence in high-risk patients undergoing midline emergency laparotomy. As secondary outcome, the associated morbidity, including surgical site occurence, will be analyzed. The study design will be a randomized controlled trial.

Conditions

Surgical Wound Dehiscence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Suture group

Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture only, without mesh, aiming a suture length to wound length ratio higher than four. Randomization occurs after fascial closure.

Group Type: ACTIVE_COMPARATOR

Midline Fascial Closure

Intervention Type: PROCEDURE

midline fascial closure using uninterrupted PDS 0 suture

Prophylactic mesh group

Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.

Group Type: EXPERIMENTAL

prophylactic polypropilene mesh

Intervention Type: DEVICE

Placement of onlay polypropilene prophylactic mesh after midline fascial closure.

Midline Fascial Closure

Intervention Type: PROCEDURE

midline fascial closure using uninterrupted PDS 0 suture

vacuum drainage system

Intervention Type: DEVICE

Placement of a subcutaneous vacuum drainage system

Interventions

prophylactic polypropilene mesh

Placement of onlay polypropilene prophylactic mesh after midline fascial closure.

Intervention Type: DEVICE

Midline Fascial Closure

midline fascial closure using uninterrupted PDS 0 suture

Intervention Type: PROCEDURE

vacuum drainage system

Placement of a subcutaneous vacuum drainage system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Emergency laparotomy by midline incision
• High risk for abdominal wound dehiscence: Risk index** ≥ 4,0 or ≥ 2,2 in combination with at least one of the following: smoking, obesity, malnutrition or malignant neoplasia.

• Risk index is the sum of values associated with high-risk characteristics, based in the risk score for abdominal wall dehiscence published by van Ramshorst et. al. in World Journal of Surgery, 2010 (Rotterdam risk model):

Age category (in years)

• 40-49: 0.4
• 50-59: 0.9
• 60-69: 0.9
• ≥70: 1.1

Male gender: 0.7

Chronic pulmonary disease: 0.7

Ascites: 1.5

Jaundice: 0.5

Anemia: 0.7

Emergency surgery: 0.6

Type of surgery:

• Gallbladder/bile duct 0.7
• Esophagus 1.5
• Gastroduodenum 1.4
• Small bowel 0.9
• Large bowel 1.4
• Vascular 1.3

Exclusion Criteria

• Non-midline incisions or midline laparotomy measuring less than 1/4 the distance between the xyphoid and the pubis, including laparoscopic surgery.
• Diagnosis of incisional hernia or presence of previous mesh on site.
• Midline laparotomy performed in less than 30 days.
• Pregnancy
• Severe trauma with hemodynamic instability
• Need for open abdomen or relaxing incisions
• Need for re-laparotomy during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed.
• Death during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed before the event.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Edivaldo Massazo Utiyama

MD, PhD, Full Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São, Brazil

Countries

Brazil

References

Gomez Diaz CJ, Rebasa Cladera P, Navarro Soto S, Hidalgo Rosas JM, Luna Aufroy A, Montmany Vioque S, Corredera Cantarin C. [Validation of abdominal wound dehiscence's risk model]. Cir Esp. 2014 Feb;92(2):114-9. doi: 10.1016/j.ciresp.2012.12.008. Epub 2013 May 3. Spanish.

Reference Type: BACKGROUND

PMID: 23648044 (View on PubMed)

van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y.

Reference Type: RESULT

PMID: 19898894 (View on PubMed)

Lima HVG, Rasslan R, Novo FCF, Lima TMA, Damous SHB, Bernini CO, Montero EFS, Utiyama EM. Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Jan;230(1):76-87. doi: 10.1016/j.jamcollsurg.2019.09.010. Epub 2019 Oct 28.

Reference Type: DERIVED

PMID: 31672681 (View on PubMed)

Other Identifiers

2024878

Identifier Type: -

Identifier Source: org_study_id