Features of Drainage of the Implant Placement Area in Patients with Incisional Ventral Hernias

Full Text

Currently, some progress has been made in the treatment of patients with postoperative ventral hernias (PVH). This is due to the widespread use of synthetic implants, which made it possible to reduce the frequency of hernia recurrence and repeated surgical interventions aimed at their elimination. However, implantation does not always result in full biointegration in the patient's tissues and may contribute to the occurrence of wound complications. The most common complication is seroma - the accumulation of serous fluid produced by tissues in the cavity of the surgical wound.

In the literature, one can come across such concepts as "clinical seroma" - a visible bulge or fluctuation without signs of infection, and "subclinical seroma" detected by ultrasound examination of a postoperative wound without abnormalities during physical examination [1].

According to ultrasound data, a small amount of fluid in the implant area is detected in almost all patients on the 5–7th day after surgery, and in the case of complete regression of the cavity of the surgical wound, it undergoes involution over time.

However, the frequency of clinically diagnosed seromas (requiring a change in the management of the postoperative period) varies widely - from 0.8 to 60% [2].

The reasons for the formation of seromas and their role in various studies are evaluated ambiguously. C. Klink et al. [3] consider age over 60 years, female gender, large size of the hernia ring, operation time over 2 hours, diabetes mellitus, and obesity as predisposing factors for the occurrence of seroma. At the same time, according to H. Kaafarani et al [4], the specifics of the operation are of decisive importance: the method (open or laparoscopic), the institution in which the operation was performed, the methods of drainage of the wound, and the features of the hernia itself (the number of previously performed operations in the abdominal cavity).

Currently, most authors believe that the prevention of wound complications in arthroplasty should be based on effective drainage of the hernioplasty zone.

In accordance with the national clinical guidelines "Postoperative ventral hernia" [5], it is considered that the methods of preventing seroma can be: excision of the hernial sac; its ablation; suturing hernial ring; fixation of the prosthesis, allowing fluid to flow out of the hernial sac; drainage of the implant location area; wearing compression underwear.

In matters of drainage of postoperative wounds, there are also different points of view. This is due to the wide variability of drainage methods and the commitment of surgeons to one or another technique.

In the Russian Federation, the generally accepted option for wound drainage after PVG hernioplasty is active blind drainage of the implant location area with Redon silicone tubular drains.

However, there are reports of significant disadvantages of this method. According to Yu.R. Mirzabekyan [6], Redon drainage does not provide control over the degree of rarefaction, does not exclude the reverse reflux of the discharge and the contact of the sterile inner lumen of the drainage with the external environment when the reservoir is emptied. A number of authors suggest using vacuum-assisted drainage systems, justifying this by the fact that they maintain a uniform and constant vacuum along the entire length of the drainage, combined with tightness and sterility [7]. However, given the prevalence of PVH, the widespread use of specialized VAC -therapy systems as a prevention of wound complications would not be economically feasible.

Methods of passive wound drainage, such as drainage with a rubber graduate (DRS) or drainage with a "groove" (GD), are still found in everyday surgical practice [8]. The main mechanisms for evacuating the accumulation of wound exudate by these methods are the pressure difference in the environment and the cavity of the surgical wound, as well as the capillary effect. However, there are data from A.V. Kuznetsova et al. [9], who prospectively studied the results of treatment of 183 patients operated on for postoperative ventral hernia with the installation of an onlay mesh implant, the postoperative period of which was accompanied by the formation of seroma. The authors came to two conclusions: 1) the least desirable way is to manage the wound leaving a drainage rubber strip 2) the use of Redon vacuum drainage in the early postoperative period for medium-sized hernias has no advantages over the puncture method in case of seroma formation.

The existing contradictions in the methods of drainage and management of patients with seromas after hernioplasty for PVH determine the relevance of this problem and the need to obtain additional data on the advantages and disadvantages of one method or another.

Aim

To analyze the results of treatment of patients with postoperative ventral hernias depending on the methods of drainage of the implant location area.

Methods

Study Design

The study analyzed the results of treatment of 392 patients with a diagnosis of postoperative ventral hernia, who were treated in the period from 2017 to 2020. GBUZ "Samara Regional Clinical Hospital named after V.D. Seredavina, which is the clinical base of the Department of Surgery of the Institute of Postgraduate Education of the Samara State Medical University of the Ministry of Health of Russia.

The study type was a non-randomized, single-center, single-stage, retrospective study.

Eligibility Criteria

Criteria for inclusion of patients in the study:

1) the presence of a ventral hernia MW2R0 and MW3R0 according to the classification of the European Herniological Society (EHS), contained in the Clinical guidelines "Postoperative ventral hernia" of the Russian Society of Surgeons (2021)[5];

2) Performed open combined tension-free hernioplasty using a mesh implant (according to Belokonev-1) [10].

Criteria for exclusion from the study: patients with indications for emergency surgery (strangulated PVH, phlegmon of the hernial sac).

Terms and Conditions

The study was conducted in the surgical department of the State Budgetary Institution of Health Care "Samara Regional Clinical Hospital named after V.D. Seredavin", which is the clinical base of the Department of Surgery of the Institute of Professional Education of the Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation.

Study duration

The study was conducted in the period 2021-2022.

Description of medical intervention

Drainage of the implant area (Optomesh macropore , Poland) at the end of the operation "Open combined tension-free hernioplasty using a mesh implant (according to Belokonev-1)" was carried out according to one of the possible options for active or passive drainage (Figure 1).

Main outcome of the study

Identification of statistically significant differences in the results of surgical treatment of patients with postoperative ventral hernias using various types of active and passive drainage in terms of the following indicators: duration of hospitalization, postoperative mortality rate, dynamics of wound discharge volume, duration of drainage, diagnosis of clinically significant seroma, number of puncture-drainage interventions under ultrasound control, the number of repeated operations in case of wound suppuration.

Subgroup Analysis

There were 37 men (33.6%) and 73 women (66.4%) in group I, 103 men (36%) and 179 women (64%) in group II (χ2 = 0.196, p>0.05). The age of the patients ranged from 32 to 83 years. The average age in group I was 43.88±13.43 years, in group II 42.26±13.14 years (Student's t = 0.7, p>0.05). The average duration of hernia before surgery in group I was 3.88±2.43 years, in group II 2.96±3.55 years (Student's t = 0.21, p>0.05). The average body mass index in group I was 32±8.14, in group II 29±9.76 (Student's t = 0.24, p>0.05).

The average duration of the operation in group I was 97±28.77 minutes, in group II 104±42.51 minutes (Student's t = 0.14, p>0.05). Concomitant diseases in patients older than 30 years were detected in 72 (65.45%) people of group I and in 165 (58.5%) people of group II (χ ² = 0.764, p>0.05). Thus, there were no statistically significant differences between the groups in terms of gender, age, average duration of hernia before surgery, average body mass index, average duration of surgery, and comorbidities.

Outcome Registration Methods

Registration of the main and additional outcomes of the study was carried out by retrospective analysis of medical records.

Statistical analysis

Sample size calculation principles : The sample size was not pre-calculated.

Methods of statistical data analysis : statistical processing of the obtained data and the construction of an array of patient data were carried out using Microsoft office 2010 programs License No. 661988271 (Microsoft, USA). Parametric indicators were reflected in the work in the form of M±σ. Comparison of non-parametric indicators was carried out by calculating the value of chi-square (χ²), parametric - by calculating the value of t - Student's criterion. Differences in indicators were considered significant if the probability of an error-free forecast was 95% or more (p<0.05).

Results

Objects (participants) of the study

The study conducted a retrospective analysis of medical records of 392 patients with a diagnosis of postoperative ventral hernia, who were treated in the period from 2017 to 2020. GBUZ "Samara Regional Clinical Hospital named after V.D. Seredavina, which is the clinical base of the Department of Surgery of the Institute of Postgraduate Education of the Samara State Medical University of the Ministry of Health of Russia. The study type was a non-randomized, single-center, single-stage, retrospective study.

Main results of the study

The analysis of the results of treatment of 110 patients of group I , who underwent passive methods of drainage of the area of the implant location zone, was carried out. The distribution of patients depending on the type of passive drainage was as follows: Drainage with a rubber strip (DRS) was carried out in 14 (12.7%) cases, drainage with a "groove" (GD) - in 86 (78.2%) cases, drainage with a cruciate drainage (DCD) - in 10 (9.1%) observations.

The dynamics of the volume of wound discharge depending on the variant of passive drainage is presented in Table 1. There were no statistically significant differences between the variants of passive drainage in terms of the dynamics of the volume of wound discharge ( p > 0.05).

The average duration of drainage in group I was 2.02±0.69 days . This is due, first of all, to a decrease in the amount of discharge through the drainage channels by the 3rd day of the postoperative period and the inefficiency of their further use.

Clinically significant seroma was diagnosed in 35 (32%) patients of group I : with DRS - in 8 (57%) patients, with GD - in 24 (27.9%), with DCD - in 3 (30%). Clinically significant seroma was statistically significantly more common in patients with DRS than in patients with GD and DCD ( χ ² = 4.742, p<0.05).

Таблица 1. Динамика объёма раневого отделяемого пациентов I группы в зависимости от варианта пассивного дренирования

Table 1. Dynamics of the volume of wound discharge in patients of group I, depending on the option of passive drainage

Вариант дренирования / Drainage option	Объём раневого отделяемого (мл) / Volume of wound discharge (ml)
	1-е сутки п/о периода / 1st day p/o period	2-е сутки п/о периода / 2nd day p/o period	3-и сутки п/о периода / 3rd day p/o period	4-е сутки п/о периода / 4th day p/o period	5-е сутки п/о периода / 5th day p/o period
Дренирование перчаточным выпускником / Drainage with a rubber strip (n=14)	14±28,15	10±17,33	<5	<5	<5
Дренирование «желобком» / Groove drainage (n=86)	32±23,77	21±32,45	14±26,15	<5	<5
Дренирование крестообразным дренажом / Drainage with cruciform drainage (n=10)	29±14,16	19±15,2	11±28,15	<5	<5
Всего / Total (n=110)	25±9,64	16,67±5,86	12,5±2,12	<5	<5

The average number of puncture - drainage interventions(PDI) under ultrasound control in patients with clinically significant seroma in Group I was 1.87 ± 0.89 procedures.

Suppuration of the surgical wound, identified by the results of bacteriological culture of the wound exudate, was diagnosed in 16 (14.5%) patients: in 6 (43%) patients with DRS, in 7 (12.3%) patients with GD and in 3 (30 %) of patients with DCD. Suppuration of the surgical wound was statistically significantly more common in patients with DRS than in patients with GD and DCD (χ ² = 10.345, p <0.01). The results of surgical treatment of patients of group I were as follows (Table 2).

Таблица 2. Сравнение вариантов пассивного дренирования зоны расположения имплантата пациентов I группы в зависимости от результатов хирургического лечения

Table 2. Comparison of options for passive drainage of the implant location area in patients of group I, depending on the results of surgical treatment

Результаты и показатели хирургического лечения / Results and indicators of surgical treatment	Варианты пассивного дренирования / Passive drainage options
	ДПВ / DRS (n=14)	ДЖ / GD (n=86)	ДКД / DCD (n=10)	Среднее значение в группе / Group average
Длительность госпитализации (койко-дней) / Length of hospitalization (bed days)	24,7±5,46	17,2±9,3	16,8±2,3	22,56±4,45
Количество пациентов с нагноением раны / Number of patients with wound suppuration	6 (43%)	7 (12,3%)	3 (30%)	-
Срок возникновения нагноения раны (от начала лечения) / Time of occurrence of wound suppuration (from the beginning of treatment)	8,2±2,1 сутки госпитализации / day of hospitalization	7,6±1,4 сутки госпитализации / day of hospitalization	6,77±3,22 сутки госпитализации / day of hospitalization	7,52±0,81 сутки госпитализации / day of hospitalization
Количество повторных операций при нагноении раны / The number of repeated operations in case of wound suppuration	2,1±1,88	1,4±1,23	1,5±0,97	1,67±0,38
Летальный исход / Fatal outcome	1 (7,1%)	3 (3,5%)	0	-

Based on the results of treatment of patients of group I, the following conclusions can be drawn. Firstly, the duration of hospitalization was statistically significantly higher in patients with DRS than in patients with GD and DCD (Student's t-test = 7.48 , p<0.01), which is associated with a higher incidence of suppuration of the surgical wound, mainly in 43% patients with DRS. The period of occurrence of wound suppuration in patients with DRS was longer, although not statistically significant (p >0.05). Most likely, this is due to the largest number of MPEs aimed at the evacuation of seromas, which naturally increases the risk of infection.

However, when comparing patients with DRS with patients with GD and DCD, the frequency of repeated surgical interventions (secondary surgical treatment) did not differ significantly, although it was higher in patients with DRS ( p > 0.05).

The postoperative mortality rate in the group was 3.6%, 4 patients died as a result of the development of phlegmon of the anterior abdominal wall, implant rejection, intestinal fistula and sepsis.

In group II , 282 patients underwent active methods of drainage of the implant location area. The distribution of patients depending on the type of active drainage was as follows: active blind drainage (ABD) was carried out in 135 (47.9%) cases, active end-to-end non-closed drainage (AENCD) - in 86 (30.5%) cases, active end-to-end closed (contour) drainage (AECD) - in 61 (21.6%) cases.

The dynamics of the volume of wound discharge, depending on the variant of active drainage, is presented in Table 3.

It was found that on the 4th and 5th days of the postoperative period, the effectiveness of ABD was statistically significantly lower compared to AENCD and AECD (p<0.01). When drains were removed after ABD, it was noted that in 74% of cases, the lumen of at least one of the tubes was occluded by a clot or an area of adipose tissue. At the same time, the volume of wound discharge evacuated in AENCD and AECD on the 5th day of the postoperative period not statistically significantly differ from the volume evacuated on the 1st day of the disease ( p>0.05).

Таблица 3. Динамика объёма раневого отделяемого в зависимости от варианта активного дренирования

Table 3. Dynamics of the volume of wound discharge depending on the option of active drainage

Вариант дренирования / Drainage option	Объём раневого отделяемого (мл) / Volume of wound discharge (ml)
	1-е сутки п/о периода / 1st day p/o period	2-е сутки п/о периода / 2nd day p/o period	3-и сутки п/о периода / 3rd day p/o period	4-е сутки п/о периода / 4th day p/o period	5-е сутки п/о периода / 5th day p/o period
Активное слепое дренирование (АСД) / Active blind drainage (ABD) (n=135)	23±17,2	15±12,87	11±7,33	3±9,13	4±4,56
Активное сквозное незамкнутое дренирование (АСНД) / Active end-to-end open drainage (AENCD) (n=86)	32±17,4	25±19,45	19±11,15	16±17,23	19±7,22
Активное сквозное замкнутое (контурное) дренирование (АСЗД) / Active end-to-end closed (contour) drainage (AECD) (n=61)	40±22,21	32±22,3	29±19,25	27±11,16	21±7,33
Всего / Total (n=282)	31,7±16,33	24,7±15,71	19,7±2,12	15,3±10,27	13±5,7

This is due to the fact that it was possible to carry out a through sanitation of the drains through one of the free ends with an antiseptic solution and achieve their full patency. Although, it is impossible not to take into account the fact that the solution for washing could get into the account of the volume of the wound discharge. To minimize this circumstance, in our clinic, washing is carried out not by a passive gravitational hydrodynamic method, but by immersing one end in a sterile vial with a sanitizing solution, while aspiration is performed at the other end using a Janet syringe. The rehabilitation vector should always be directed from potentially clean zones to drain ones. When the patency of the drainage is achieved by aspiration with Janet's syringe, the free end of the drainage rises from the vial solution, and the entire sanitizing solution is fully aspirated with the syringe along with the air flow.

The average drainage time in group II was 6.33 ±2.12 days.

Clinically significant seroma was diagnosed in 42 (14.9%) patients of group II : with ABD in 23 (17.03%) patients, with AENCD in 12 (13.9%), with ABDD in 7 (11.4%) . Clinically significant seroma was more common in ABD than in AENCD and ABDD, although not statistically significant (χ² = 0.93, p>0.05). The average number of PDIs under ultrasound control in patients with clinically significant seroma in group II was 0.65 ± 0.39 procedures. Suppuration of the surgical wound, identified by the results of bacteriological culture of wound exudate, was diagnosed in 21 (7.4%) patients: in 11 (8.1%) patients with ABD, in 6 (6.9%) patients with AENCD and in 4 (6.5%) patients with ABDD. The frequency of suppuration of the surgical wound, depending on the type of active drainage, did not differ significantly, although it was more common in ABD ( χ ² = 0.185, p>0.05).

The results of surgical treatment of patients of group II looked as follows (Table 4).

Based on the results of treatment of patients of group II, the following conclusions can be drawn.

First, the duration of hospital stay was statistically significantly longer in patients with ABD than in patients with AENCD and AECD (Student's t test = 6.5, p<0.01), which is associated with a higher incidence of clinically significant seroma and suppuration surgical wound in patients with ABD. The onset of wound suppuration in patients with ABD was statistically significantly later than in patients with AENCD and AECD (Student's t-test = 7.17, p<0.01). Most likely, this is due to a violation of the drainage sanitation technique and early contamination. In the case of ABD, the cause of the suppuration of the surgical wound was a clinically significant seroma and subsequent attempts to drain it with the help of PDI under ultrasound guidance.

Таблица 4. Сравнение вариантов активного дренирования зоны расположения имплантата пациентов II группы в зависимости от результатов хирургического лечения

Table 4. Comparison of options for active drainage of the implant location area in patients of group II, depending on the results of surgical treatment

Результаты и показатели хирургического лечения / Results and indicators of surgical treatment	Варианты активного дренирования / Active drainage options
	АСД / ABD (n=135)	АСНД / AENCD (n=86)	АСЗД / AECD (n=61)	Среднее значение в группе / Group average
Длительность госпитализации (койко-дней) / Length of hospitalization (bed days)	16,7±3,23	11,2±4,4	9,8±2,1	13,57±2,92
Количество пациентов с нагноением раны / Number of patients with wound suppuration	11 (8,1%)	6 (6,9%)	4 (6,5%)	-
Срок возникновения  нагноения раны (от начала лечения), сутки / Time of occurrence of wound suppuration (from the beginning of treatment), day	8,1±1,7	3,3±1,6	2,65±1,14	5,43±1,01
Количество повторных операций при нагноении раны / The number of repeated operations in case of wound suppuration	1,1±1,03	0,4±1,4	0,3±1,32	0,63±0,33
Летальный исход / Fatal outcome	3 (1,7%)	2 (2,3%)	1 (1,6%)	-

The frequency of repeated surgical interventions in patients with different types of active drainage did not differ significantly (p>0.05).

The postoperative mortality rate in group II was 2.1%, 6 patients died as a result of the development of phlegmon of the anterior abdominal wall, implant rejection, intestinal fistula and sepsis. Comparison of the results of active and passive drainage is presented in Table 5.

Таблица 5. Результаты хирургического лечения пациентов I и II групп в зависимости от способа дренирования зоны расположения имплантата

Table 5. The results of surgical treatment of patients of groups I and II , depending on the method of drainage of the implant location area

Вариант дренирования / Drainage option	Длительность госпитализации (койко-дней) / Length of hospitalization (bed days)	Количество пациентов с нагноением раны / Number of patients with wound suppuration	Срок возникновения нагноения (сут) / Duration of suppuration (days)	Количество повторных операций / Number of reoperations	Летальный исход / Fatal outcome
Пассивное дренирование / Passive drainage (n=110)	22,56±4,45	16 (14,5%)	7,52±0,81	1,67±0,38	4 (3,6%)
Активное дренирование / Active drainage (n=282)	13,57±2,92	21 (7,4%)	5,43±1,01	0,63±0,33	6 (2,1%)
t-критерий Стьюдента / t -Student's criterion, χ 2	t=11,51 p<0,01	χ2 = 4,665, p<0,05	t=4,93 p<0,01	t=0,82, p>0,05	χ2 = 0,725, p>0,05

Adverse events

There were no lethal outcomes due to decompensation of chronic diseases in the study. Adverse events in the management of patients in the postoperative period could be contamination of the lumen of the drains and the area of the implant, both due to retrograde lavage, and due to leakage of wound discharge from the "accordion" along the drains in the patient's prone position.

Discussion

Completion of hernioplasty for PVH using active drainage methods, in comparison with passive drainage methods, statistically significantly reduces the duration of hospitalization of patients (t-Student = 11.51 p<0.01), which ultimately reduces the cost of medical facilities for the treatment of this cohort sick. The frequency of clinically diagnosed seromas is statistically significantly higher in the group of patients with passive drainage than in the group of patients with active drainage (χ2 = 14.36, p<0.01), which indicates the need to abandon passive drainage of the implant location. Suppuration of the postoperative wound statistically significantly more often occurs with passive drainage of the implant location area (χ2 = 4.665, p<0.05);

With passive drainage of the implant location area, wound suppuration occurs statistically significantly later than with active drainage (t-Student = 4.93 p<0.01). This circumstance is associated with the absence of conditions for accidental contamination of the implant location area during the sanitation of drains or leakage of exudate through the drains from the accordion vacuum device, as well as the removal of passive drains in the first 3 days of the postoperative period. The frequency of reoperations as well as the incidence of death did not differ significantly between the groups (Student's t = 0.82, p>0.05; χ2 = 0.725, p>0.05, respectively), which is usually used as " argument” by surgeons to expand the choice of drainage options.

Conclusion

In patients with PVH, when choosing the option of drainage of the implant location zone, preference should be given to active through open drainage or active through closed drainage, since these options show significantly better results compared to other drainage methods. When maintaining drainage (sanation, control of patency) in the postoperative period, it is necessary to strictly observe the rules of asepsis to prevent artificial iatrogenic contamination.

About the authors

Evgenii Anatol'evich Korymasov

Federal State Budgetary Educational Institution of Higher Education «Samara State Medical University» of the Ministry of Healthcare of the Russian Federation;
State budgetary health care institution "Samara Regional Clinical Hospital named after V.D. Seredavin"

Email: korymasov@mail.ru
ORCID iD: 0000-0001-9732-5212
SPIN-code: 9928-6343
Scopus Author ID: 6603084839

Head of the Department of Surgery, IPO, Samara State Medical University of the Ministry of Health of Russia, Honored Worker of Science of the Russian Federation, Doctor of Medical Sciences, Professor

Russian Federation, Russia, Samara, Chapaevskaya St., 89; Russia, Samara str. Tashkent 159.

Evgenii Petrovich Krivoschekov

Federal State Budgetary Educational Institution of Higher Education «Samara State Medical University» of the Ministry of Healthcare of the Russian Federation

Email: walker02@mail.ru
ORCID iD: 0000-0001-9780-7748
SPIN-code: 6114-5014

Honored Doctor of the Russian Federation, Doctor of Medical Sciences, Professor

Russia, Samara, Chapaevskaya St., 89;

Maksim Yurievich Khoroshilov

Federal State Budgetary Educational Institution of Higher Education «Samara State Medical University» of the Ministry of Healthcare of the Russian Federation;
State Budgetary Institution of Health Care "Samara Regional Clinical Hospital named after V.D. Seredavin"

Email: khor-maksim@yandex.ru
ORCID iD: 0000-0002-9659-8881
SPIN-code: 6048-6009

Assistant of the Department of Surgery IPE, Candidate of Medical Sciences, Surgeon

Russian Federation, Russia, Samara, Chapaevskaya St., 89; Russia, Samara str. Tashkent 159.

Sergey Anatol'evich Ivanov

Federal State Budgetary Educational Institution of Higher Education «Samara State Medical University» of the Ministry of Healthcare of the Russian Federation

Email: docisa@mail.ru
ORCID iD: 0000-0003-3590-1071
SPIN-code: 8732-7730

Professor of the Department of Surgery, IPO, Associate Professor, MD

Russia, Samara, Chapaevskaya St., 89;

Vladimir Vladimirovich Kolesnikov

Federal State Budgetary Educational Institution of Higher Education «Samara State Medical University» of the Ministry of Healthcare of the Russian Federation

Email: drvvk@yandex.ru
ORCID iD: 0000-0003-4719-1185
SPIN-code: 9130-9085

Professor of the Department of Surgery of the Institute of Postgraduate Education, MD

Russian Federation, Russia, Samara, Chapaevskaya St., 89;

Bahtiar Madatovich Rakhimov

Federal State Budgetary Educational Institution of Higher Education «Samara State Medical University» of the Ministry of Healthcare of the Russian Federation

Author for correspondence.
Email: rahimovbm@mail.ru
ORCID iD: 0000-0001-5816-6589
SPIN-code: 9726-2163

Professor of the Department of Surgery of the Institute of Postgraduate Education, MD

Russia, Samara, Chapaevskaya St., 89;

References

Supplementary files