Clinical trial NCT04562363: Prevention of Postoperative Ventral Hernias
Official title: Prevention of Postoperative Ventral Hernias After Median Laparotomy in Urgent Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gangrenous Postoperative Ventral Hernia (Diagnosis)
Dehiscence of Laparotomy Wound
Keywords: Postoperative ventral hernia
eventrat
defects of the fascia
laparotomic wound suture
preventive prosthetics of a laparotomic wound
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The prospective study included 700 patients, including those operated through a midline laparotomic approach to identify factors of herniation, and those who are planned to have a midline laparotomy in order to choose a rational method of suturing a laparotomic wound, taking into account the risk of incisional hernia formation. Taking into account the degree of risk of postoperative ventral hernia development and the choice of the method of its prevention, the patients were divided into 4 groups.

Brief summary: The research is aimed at identifying factors of herniation after median laparotomy and developing surgical methods for preventing postoperative ventral hernias and eventrations.

Detailed description: At the first stage, an analysis of the prevalence of postoperative ventral hernias in patients after median laparotomies in urgent surgery will be performed, with the identification of factors contributing to the development of postoperative ventral hernias. At the next stage, the investigators will search for the most reliable methods of suturing the white line of the abdomen, taking into account the risk of hernia formation, with their implementation in patients operated in an emergency through median laparotomic access in comparison with traditionally used methods. In conclusion, an algorithm will be developed for selecting the method of surgical prevention of postoperative ventral hernias, taking into account the risk of their development.

Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes aged 18 years and older who are expected to perform median laparotomy on a planned or emergency basis.
2. Patients who have signed an informed consent to participate in the study, after the purpose and meaning of the study have been explained to them.
3. Patients who follow the doctor's instructions.

Exclusion Criteria:

1. The death of the patient.
2. Stage IV cancer
3. Hernia repair with hernioplasty, including simultaneous surgery
4. Refusal of the patient to cooperate with the researcher.

Primary outcomes:
measure: Wound complications
timeFrame: 2 weeks
measure: Eventration
timeFrame: 2 weeks
measure: Pain syndrome
timeFrame: 2 year
measure: Postoperative ventral hernia
timeFrame: 2 year
measure: Defects in the aponeurosis
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ryazan
country: Russian Federation
facility: RyazSMU
state: Ryazan Region
city: Ryazan
country: Russian Federation
facility: RyazSMU
Study officials:
affiliation: RyazSMU
name: Alexander Inyutin, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: