Prevention of Postoperative Ventral Hernias

NCT04562363 | Completed

• 1 other identifier: POVG12122021
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Low risk of herniation.

Use of any method of suturing, including modified.

Procedure: Suturing of a laparotomic wound with modified methods

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

high risk of herniation

The use of alloplastic methods of closure of laparotomy wound.

Procedure: Suturing of a laparotomic wound with modified methods

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

Interventions

Suturing of a laparotomic wound with modified methods PROCEDURE

Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations

Low risk of herniation.; The average risk of hernia formation; The presence of eventrations; high risk of herniation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients of both sexes aged 18 years and older who are expected to perform median laparotomy on a planned or emergency basis.
• 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.
• Patients who follow the doctor's instructions.

You may not qualify if:

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

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (2)

RyazSMU

Ryazan, Ryazan Oblast, 390026, Russia

Location

RyazSMU

Ryazan, Russia

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Inyutin, PhD MD

  RyazSMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 24, 2020
• Study Start: December 12, 2018
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: February 14, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)