Prevention of Postoperative Ventral Hernias

Completed

• Conditions: Gangrenous Postoperative Ventral Hernia (Diagnosis); Dehiscence of Laparotomy Wound
• Interventions: Procedure: Suturing of a laparotomic wound with modified methods

• Registration Number: NCT04562363
• Lead Sponsor: Ryazan State Medical University

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.

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-24
• Status Verified: 2021-10
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-12
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high risk of herniation	Suturing of a laparotomic wound with modified methods	The use of alloplastic methods of closure of laparotomy wound.
The presence of eventrations	Suturing of a laparotomic wound with modified methods	The use of alloplastic methods of suturing a laparotomic wound in the absence of suppuration.
Low risk of herniation.	Suturing of a laparotomic wound with modified methods	Use of any method of suturing, including modified.
The average risk of hernia formation	Suturing of a laparotomic wound with modified methods	The application of modified methods of closure of laparotomy wound.

Primary Outcome Measures

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

Trial Locations

Locations (1)

RyazSMU; 🇷🇺 Ryazan, Russian Federation