Prevention of Postoperative Ventral Hernias

Prevention of Postoperative Ventral Hernias After Median Laparotomy in Urgent Surgery

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

Study Overview

• Status: Completed
• Conditions: Gangrenous Postoperative Ventral Hernia (Diagnosis); Dehiscence of Laparotomy Wound
• Intervention / Treatment: Procedure: Suturing of a laparotomic wound with modified methods

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.

• Study Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• Russian Federation
  • Ryazan, Russian Federation
    • RyazSMU
  • Ryazan Region
    • Ryazan, Ryazan Region, Russian Federation, 390026
      • RyazSMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low risk of herniation.; Use of any method of suturing, including modified.	Procedure: Suturing of a laparotomic wound with modified methods; Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
The average risk of hernia formation; The application of modified methods of closure of laparotomy wound.	Procedure: Suturing of a laparotomic wound with modified methods; Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
high risk of herniation; The use of alloplastic methods of closure of laparotomy wound.	Procedure: Suturing of a laparotomic wound with modified methods; Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
The presence of eventrations; The use of alloplastic methods of suturing a laparotomic wound in the absence of suppuration.	Procedure: Suturing of a laparotomic wound with modified methods; Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound complications	Frequency of wound complications in the early postoperative period.	2 weeks
Eventration	Frequency of events in the early postoperative period	2 weeks
Pain syndrome	The severity of pain syndrome in the postoperative scar after midline laparotomy using a verbal scale of pain syndrome	2 year
Postoperative ventral hernia	Frequency of postoperative ventral hernia in the late postoperative period	2 year
Defects in the aponeurosis	Frequency of aponeurosis defects in the late postoperative period	2 year

Collaborators and Investigators

• Sponsor: Ryazan State Medical University
• Investigators: Principal Investigator: Alexander Inyutin, PhD MD, RyazSMU

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative ventral hernia; eventrat; defects of the fascia; laparotomic wound suture; preventive prosthetics of a laparotomic wound
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: POVG12122021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Undecided Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No