Prevention of Postoperative Ventral Hernias

Sponsor

Ryazan State Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04562363

Collaborator

(none)

700

Enrollment

Locations

Actual Duration (Months)

350

Patients Per Site

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gangrenous Postoperative Ventral Hernia (Diagnosis) Dehiscence of Laparotomy Wound	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 Design

Study Type:

Observational

Actual Enrollment :

700 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prevention of Postoperative Ventral Hernias After Median Laparotomy in Urgent Surgery

Actual Study Start Date :

Dec 12, 2018

Actual Primary Completion Date :

Dec 12, 2021

Actual Study Completion Date :

Dec 12, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Wound complications [2 weeks]
Frequency of wound complications in the early postoperative period.
Eventration [2 weeks]
Frequency of events 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.