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Maligne Erkrankungen: Evidenz zur Wunddrainage nach erfolgter Lymphknotenresektion der Leiste

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Zusammenfassung

Hintergrund

Die inguinale Lymphadenektomie wird im Allgemeinen für die Behandlung einer Vielzahl von Krebsarten, einschließlich Melanomen und Plattenepithelkarzinomen der Haut, des Penis oder der Vulva durchgeführt. Es gilt als nicht gesichert, ob eine Wunddrainage die Komplikationsrate dieses Eingriffs reduziert. Ferner ist zu evaluieren, wann der optimale Zeitpunkt zur Drainagenentfernung ist.

Ziele

Ziel des Reviews ist es, den Grad der Evidenz dafür zu bestimmen, ob die Platzierung einer Wunddrainage nach inguinaler Lymphadenektomie im Hinblick auf die Verringerung von Komplikationen (z. B. Serome, Hämatome, Wunddehiszenz und Wundinfektionsraten) nutzbringend ist, und was die optimale Art und Dauer der Ableitung ist, wenn sie sich als nutzbringend erweist.

Literatursuche

Im September 2014 haben wir mit einer vorgefertigten Suchstrategie in den folgenden elektronischen Datenbanken nach Literatur gesucht: im Cochrane Wounds Group Specialised Register und im Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library). Im November 2013 haben wir Ovid MEDLINE; Ovid MEDLINE (In‐Process & Other Non‐Indexed Citations); Ovid EMBASE und EBSCO CINAHL durchsucht. Wir haben für die Suche und die Auswahl der Studien keine Einschränkungen in Bezug auf Sprache, Publikationsdatum oder Studiensetting vorgenommen.

Auswahlkriterien

Es wurden alle randomisierten, kontrollierten Studien (RCTs), in denen Wunddrainage versus keine Wunddrainage bei Personen nach inguinaler Lymphadenektomie verglichen wurde, betrachtet, wo der Cloquet‐Lymphknoten (der am weitesten proximal gelegene Leistenlymphknoten) entfernt wurde. Es wurden keine Einschränkungen für die Sprache der Veröffentlichung oder den Studienort vorgenommen. Zwei Review‐Autoren haben unabhängig voneinander die Eignung jeder Studie bestimmt.

Datenerhebung und ‐analyse

Zwei Autoren haben unabhängig voneinander die durch die Suche identifizierten Studien auf Einschluss geprüft. Es gab keine Meinungsverschiedenheiten.

Wesentliche Ergebnisse

Wir haben keine RCTs identifiziert, welche den Einschlusskriterien des Reviews entsprachen.

Schlussfolgerungen der Autoren

Für die klinische Praxis in diesem noch wenig erforschten Bereich sind RCTs von hoher Qualität erforderlich.

Plain language summary

The effects of using drainage tubes after surgical removal of lymph glands from the groin

What are lymph glands?

Lymph glands are part of the body's immune system and swell or enlarge when the body is fighting an infection. They are located in a number of places in the body, including the neck, armpits, and groin.

Why remove lymph glands?

Surgical removal of the lymph glands found in the groin (the inguinal lymph nodes) is an important part of the treatment for several types of cancer, including melanoma and other types of skin cancer, as well as squamous cell cancer of the penis, vulva and the surrounding skin. Sometimes complications, such as wound infection, bruising (haematoma) or a collection of lymph fluid in the area (seroma), can occur after removal of these lymph nodes.

Why insert drainage tubes after surgery?

Surgeons can insert plastic drainage tubes into the area from which the lymph nodes have been removed. These tubes are inserted towards the end of the operation, once the lymph glands have been removed. The aim of the drainage tubes is to drain away any fluid or blood that may collect in the wounds and cause complications. The drains are usually left in place until the amount of fluid draining out of them in a 24‐hour period has reduced to a certain volume (typically less than 30 mL to 100 mL), although some surgeons will remove the drains at a particular time point after surgery (this can vary from 1 day to more than 1 week). Patients can remain in hospital while the drain is in place, although many surgeons will let patients leave hospital and have the drain managed on an outpatient basis.

However, it is unclear whether placement of a drainage tube reduces, increases or has no effect on complications following this type of surgery. Furthermore the best timing for removal of drainage tubes is unknown.

The purpose of this review

The aim of this review was to review all randomised clinical trials (RCTs) that have compared what happens to patients who had a drain inserted after removal of the inguinal lymph nodes with patients who did not have a drain. We also looked for RCTs that examined the effect of removing drains at different times. We searched the medical literature up to September 2014 to gather all the available evidence.

What the review discovered

We did not identify any RCTs that compared what happens when you do or do not use drains after surgery for inguinal lymph node removal and therefore we still do not know if drains are beneficial in this context.

Authors' conclusions

Implications for practice

At present the impact of wound drainage following groin dissection for malignant disease in adults remains unclear and clinicians have minimal evidence on which to base their decision making regarding the role of wound drainage following groin dissection.

Implications for research

This review has identified an urgent and pressing need for high quality randomised trials comparing groin drain insertion with no drain in patients following inguinal lymph node dissection for all causes of pathology. At present there is no evidence from randomised controlled trials available to guide clinical decision making for the benefit of patients in this important area. Trials have been conducted to investigate the impact of drain insertion for pelvic lymph node dissection for both gynaecological and oncological surgeries, therefore, it is reasonable to suppose that a trial of drain insertion for inguinal dissection would be feasible, and ethical given the current state of balance of clinicians (Coblentz 2002; Serpell 2003; Ul‐Mulk 2012).

Background

Description of the condition

Groin dissection, also known as inguinal lymphadenectomy or inguinal lymph node dissection, is commonly performed as part of the treatment for some tumours, including melanoma, and squamous cell carcinoma of the skin, penis or vulva, as well as other less common tumours (Gaarenstroom 2003; Swan 2003; Margulis 2010). It involves removal of all of the lymph nodes in the anatomical area known as the femoral triangle, at the upper inner part of the thigh. When groin dissection is performed because of confirmed spread (metastasis) of cancer to a lymph node, the procedure is referred to as a therapeutic lymph node dissection (TLND), and when it is performed because there is a high risk that a cancer might have spread to a lymph node, it is known as a prophylactic lymph node dissection (PLND). Recently the development of sentinel lymph node biopsy (SLNB), a procedure that involves the removal of one or more 'sentinel' lymph nodes (the first node, or group of nodes, to which a cancer will metastasise), has allowed the detection of clinically hidden (occult) micrometastases in the inguinal lymph nodes via a microscope, which could not be detected by examining the patient. In these cases, if the SLNB is positive for metastatic disease, a complete lymph node dissection (CLND) may be performed (Hakim 2006; Morton 2006; Yeung 2013). According to Hospital Episode Statistics, 688 inguinal lymph node dissections were performed in England in the year 2011 to 2012 (HSCIC).

Description of the intervention

At the end of the groin dissection, the surgeon usually places one or more drains in the wound (Ul‐Mulk 2012). Commonly, closed suction drains are used, however it is possible that some surgeons may use other drainage systems, such as epidermal vacuum therapy (Tauber 2013). Surgeons use either a volume‐directed indication for removal of the drain(s), for example when drainage is less than 30 ml in 24 hours (Serpell 2003), or a time‐directed indication for removal of the drain(s), for example on the seventh post‐operative day irrespective of drain output (Coblentz 2002).

How the intervention might work

Standard surgical teaching suggests that a drain tube should be placed inside the cavity created by the surgery at the end of the procedure. This will allow any blood or fluid to drain away, thereby preventing the accumulation of blood (haematoma) or serous fluid (seroma) in the cavity and helping to collapse dead space (Serpell 2003). It is thought that haematoma and seroma rates will be decreased by allowing fluid to drain from the wound. Conversely, complications such as wound infection may be increased by placement of a drain, as it provides bacteria with a potential portal for entry into the subcutaneous space (Samraj 2007; Carlson 2008).

Why it is important to do this review

It is not clear whether drainage following inguinal lymph node dissection is beneficial. Furthermore, there is uncertainty regarding the correct time to remove drains, and whether to use a time‐ or volume‐directed indication for removal. It is unclear whether insertion of a drain into the groin reduces, or increases, complication rates after this surgery. There have been no previous reviews addressing this question. This systematic review aimed to clarify this issue and define the quality of evidence supporting current practice.

Objectives

To assess the current level of evidence to determine whether placement of a drain is beneficial after groin dissection in terms of reducing seroma, haematoma, wound dehiscence and wound infection rates, and to determine the optimal type and duration of drainage following groin dissection if it is shown to be beneficial.

Methods

Criteria for considering studies for this review

Types of studies

We considered only randomised controlled trials (RCTs) to be eligible for inclusion.

Types of participants

  • Patients having groin dissection for metastatic malignant disease, including ‐ but not limited to ‐ malignant melanoma, squamous cell carcinoma of the skin, penis, vulva or anus. The groin dissection could be therapeutic, prophylactic or completion (see Description of the condition).

  • People over 18 years of age; no restriction by gender, no restriction on country of origin.

  • The setting for this surgery was hospital inpatient care; adverse events that occurred in the outpatient setting were to be assessed if recorded by the studies.

We excluded trials in which participants underwent more extensive surgery, where dissection included higher lymph node groups including iliac, pelvic and para‐aortic nodes. We deemed Cloquet’s node (the most superior inguinal node in the proximal groin) to be the superior limit of dissection for eligible studies.

Types of interventions

We decided to include studies reporting the following comparisons (all references below to the use of a surgical drain(s) allude to those inserted into the groin following inguinal lymph node dissection):

  • wound drainage compared with no wound drainage;

  • one type of wound drain compared with another type of wound drain;

  • different timing of drain removal: to include removal according to fixed‐time and fixed‐volume protocols.

Types of outcome measures

Primary outcomes

  • Wound complications by final follow‐up (as defined by study authors; including any or all of: dehiscence (wound breakdown), haematoma, seroma).

  • Wound infection, as defined by the Centers for Disease Control and Prevention (CDC) criteria (Horan 1992): that is, infection occurring within 30 days after groin dissection and the patient had at least one of the following:

    • purulent drainage from the superficial incision;

    • micro‐organisms isolated from an aseptically‐obtained culture of fluid or tissue from the superficial incision;

    • superficial incision that is deliberately opened by a surgeon and is culture‐positive, or not cultured and the patient had at least one of the following signs or symptoms: pain or tenderness; localised swelling; redness; or heat;

    • diagnosis of a superficial incisional surgical site infection by the surgeon or attending physician.

Secondary outcomes

  • Length of hospital stay.

  • Volume of fluid drained.

  • Number of aspirations.

  • Drain reinsertion.

  • Lymphoedema.

  • Quality of life outcomes including patient‐reported outcome measures, e.g. pain scores (using a validated scale).

  • Adverse events (in any setting).

Search methods for identification of studies

Electronic searches

We searched the following electronic databases to identify reports of relevant RCTs:

  • The Cochrane Wounds Group Specialised Register (4 September 2014);

  • The Cochrane Central Register of Controlled Trials (CENTRAL ) (The Cochrane Library 2014, Issue 8);

  • Ovid MEDLINE (1946 to October Week 5 2013);

  • Ovid MEDLINE (In‐Process & Other Non‐Indexed Citations 6 November 2013);

  • Ovid Embase (1974 to 2013 November 06)

  • EBSCO CINAHL (1982 to 07 November 2013).

We used the following search strategy in the Cochrane Central Register of Controlled Trials (CENTRAL):

#1 MeSH descriptor: [Lymph Node Excision] explode all trees 1033
#2 MeSH descriptor: [Lymph Nodes] explode all trees and with qualifiers: [Surgery ‐ SU] 76
#3 ("inguinal lymph node dissection" or "inguinal lymphadenectomy" or (groin next dissect*) or (groin next surg*)):ti,ab,kw 38
#4 {or #1‐#3}
#5 MeSH descriptor: [Drainage] explode all trees 1986
#6 MeSH descriptor: [Suction] explode all trees 733
#7 drain*:ti,ab,kw 4040
#8 #5 or #6 or #7 4641
#9 #4 and #8 133

The search strategies for Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL can be found in Appendix 1, Appendix 2 and Appendix 3 respectively. We adapted this strategy to search Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL. We combined the Ovid MEDLINE search with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and precision‐maximising version (2008 revision) (Lefebvre 2011). We combined the EMBASE search with the Ovid EMBASE filter developed by the UK Cochrane Centre (Lefebvre 2011). We combined the CINAHL searches with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2011). We did not restrict trials with respect to language, date of publication or trial setting.

We searched the following clinical trials registries:

Searching other resources

Two review authors (DT, HS) checked the reference lists of included trials independently for additional eligible trials.

Data collection and analysis

Selection of studies

Two review authors (DT, HS) independently determined the eligibility of each trial identified by analysing the titles and abstracts of all citations found through the search strategy previously described. We retrieved a full‐text copy of each citation that reported a potentially eligible trial, and for records where eligibility could not be determined by the title and abstract alone. Working independently, the two review authors applied the eligibility criteria; any discrepancies were resolved by consensus discussion with the third review author (DF). Where necessary, we sought additional information from the principal investigator of the trial concerned. We justified any exclusion of a potentially eligible trial from the review in the final report.

Data extraction and management

We did not identify any trials that could be included in the review. However, in future, if suitable trials are published, the plan is that two review authors (DT, HS) independently will extract data for each included trial using a pre‐designed data extraction form to extract the following data:

  • details of the trial (first author, year of publication, journal, publication status, period and country of trial, sources of funding, trial design, sample size);

  • patient characteristics (age, sex, type of disease, stage of disease, type of surgery and prior treatment status);

  • quality of the trial;

  • details of the surgery (PLND, TLND or CLND, number of nodes removed);

  • details of the intervention;

  • clinical variables related to patient well‐being;

  • duration of follow‐up; and

  • outcomes.

The third review author (DF) will resolve any discrepancies regarding data extraction, in order to reach consensus. In the presence of multiple reports on n included trial, we will assemble the most complete data‐set feasible for the trial.

Assessment of risk of bias in included studies

We did not identify any trials that could be included in the review. However, in future, if suitable trials are published, two review authors (DT, HS) independently will assess each trial for risk of bias using the Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011). Selection bias, performance bias, detection bias, attrition bias and reporting bias will be considered for each individual trial. Where there are unclear risks of bias due to inadequate descriptions within the trial report, we will attempt to contact the trial authors in order to clarify the risk. All efforts made to obtain additional information will be reported in the review. Any discrepancies will be resolved by consensus discussion with the third review author (DF).

Measures of treatment effect

We did not identify any trials that could be included in the review. However, in future, if suitable trials are published, we will analyse dichotomous variables (wound complications, wound infection, drain re‐insertion, lymphoedema) as risk ratios (RR) with 95% confidence intervals (CI). We will analyse continuous variables (length of stay, volume of fluid drained, number of aspirations, total aspirate volume, total volume of drainage, patient‐reported outcome measures) as mean differences. Where different scales are used to assess continuous outcomes, we will analyse using standardised mean difference (SMD).

Unit of analysis issues

We did not identify any trials that could be included in the review. However, in future, if suitable trials are published, we will use the clinically relevant time points reported in each trial to calculate complication rates. Wound infection, as defined by the CDC criteria, has to occur within 30 days of the procedure, therefore this time point will be used as a cut‐off for this outcome measure (see above). Where cluster‐randomised trial designs are encountered, including, for example, randomisation by surgeon, or by operating list, we will analyse on the basis of allocation, using summary values for each cluster.

If bilateral groin dissections are performed with separate randomisation of each groin, we plan to analyse the results on a 'per groin' rather than a 'per participant' basis, as the outcomes of the two sides are likely to be independent, except for patient‐reported outcome measures, which will not be analysed in these participants, as the effects of the two interventions are not separable. We also plan to conduct a sensitivity analysis on a 'per participant' basis to determine if there is an effect of bilateral groin dissections in the same patient.

Dealing with missing data

We did not identify any trials that could be included in the review. However, in future, if the results of an RCT are published, but information on the outcome of interest is not reported, we will contact the trial authors for the missing information. Where continuous data are not presented as mean and standard deviations we contact the trial authors for the information in this format. All efforts made to obtain additional information will be reported in the completed review. Where possible, we intend to analyse by intention‐to‐treat (Hollis 1999). If participants are allocated to one intervention, but after randomisation underwent a different intervention, they will be analysed according to their randomisation allocation. If the results for dichotomous variables are not reported in some participants, we will base our analysis on both a worst possible outcome (for example, wound infection occurred in all non‐reported cases), and a best possible outcome (for example, wound infection did not occur in all non‐reported cases). Where participants are excluded from the analysis without good cause, we will conduct a sensitivity analysis to determine any effect of attrition bias.

Assessment of heterogeneity

We did not identify any trials that could be included in the review. However, in future, if suitable trials are published, we will explore heterogeneity using the Chi2 test with significance set at P value 0.10, and measure the quantity of heterogeneity using the I2 statistic (Higgins 2002).

Thresholds for the interpretation of the I2 statistic can be misleading. A rough guide to the interpretation used is as follows:

  • 0% to 40%: might not be important;

  • 30% to 60%: may represent moderate heterogeneity;

  • 50% to 90%: may represent substantial heterogeneity;

  • 75% to 100%: considerable heterogeneity.

When interpreting the I2 statistic, we will take factors such as clinical and methodological heterogeneity, along with whether the heterogeneity is in the magnitude of effect or in the direction of effect, into account, particularly where ranges overlap.

Assessment of reporting biases

We did not identify any trials that could be included in the review. However, in future, if suitable trials are published, we will compare the reported outcomes with those stated in the methods of the trials, and also those listed in the protocols in clinical trials registries as both primary and secondary outcomes. Where sufficient trials are identified (a minimum of 10), we will assess for publication bias by creating a funnel plot using software within Review Manager 5.3, using visual inspection to detect publication bias.

Data synthesis

We did not identify any trials that could be included in the review. However, in future, if suitable trials are published, we will present a narrative overview of any included trials. Where appropriate, we will present meta‐analyses of outcome data using RevMan 5.3 (RevMan 2014). The decision to pool data in a meta‐analysis will depend on the availability of outcome data and the assessment of between‐trial heterogeneity. Where trials measure the same underlying effect we plan to use a fixed‐effects model, and where this is not the case we plan to use a random‐effects model ‐ if sufficient studies are identified to inform the distribution of effects (i.e. more than five trials). However, we do not intend to pool data where heterogeneity is very high (I² values of 75% or above).

For dichotomous outcomes we plan to present the summary estimate as a risk ratio (RR) with 95% confidence intervals (CI). Where continuous outcomes are measured in the same way across trials, we will present a mean difference (MD) with 95% CI. Where trials measure the same outcome using different methods we will present a standardised mean difference (SMD).

Subgroup analysis and investigation of heterogeneity

If suitable trials are published in future, we will consider the following variables for subgroup analyses.

  • Effects of CLND or PLND versus TLND. These subgroups may behave differently, as those patients undergoing a TLND have macroscopic cancer in the lymph node basin, which, theoretically, may require a larger volume of tissue to be removed and create a larger dead space, thereby increasing the potential drainage after inguinal lymph node dissection. By contrast, some authors have suggested that, when compared to TLND, CLND has an increased risk of wound infection owing to two procedures having been performed in the same anatomical location in rapid succession (de Vries 2006).

  • Type of cancer, for example melanoma versus vulval cancer, versus anal cancer, versus penile cancer.

  • Type of drain used, for example closed suction drainage versus gravity drainage.

Ability to conduct such analyses will also depend on whether the required information is recorded in the trial publications. If data are not included, we plan to contact trial authors to obtain the data.

Sensitivity analysis

If suitable trials are published in future, we plan to undertake a sensitivity analysis that includes, and then excludes, trials at high risk of bias, repeating this analysis to include trials at unclear risk of bias as well. We acknowledge that there is no accepted definition of what constitutes a trial at high risk of bias, therefore, we intended to assess the severity of any biases for each outcome. We intended to assess risk of bias using the Cochrane Collaboration 'Risk of bias' tool (Higgins 2011).

Presentation of results

If suitable trials are published in future, we will present the main results of the review in 'Summary of findings' tables, which provide key information concerning the quality of evidence, the magnitude of effect of the interventions examined, and the sum of available data on the main outcomes, as recommended by the Cochrane Collaboration (Schünemann 2011a). We will include the following main outcomes in the 'Summary of findings' tables.

  • Wound complications (dehiscence, haematoma, seroma).

  • Wound infection.

The 'Summary of findings' table will include an overall grading of the evidence related to each of the main outcomes, using the GRADE approach (Schünemann 2011b).

Results

Description of studies

Results of the search

A total of 308 unique records were retrieved following removal of duplicate records. There were no ongoing trials identified from the WHO ICTRP, EU clinical trials register or ClinicalTrials.gov. Sixteen potentially eligible studies were identified for abstract screening. Of these, eight records were considered to be potentially relevant and retrieved for full text review, but none of these eight studies met our predefined inclusion criteria.

Included studies

No RCTs were identified that compared patients undergoing inguinal lymph node dissection with or without drains inserted into the inguinal region.

Excluded studies

Eight studies were excluded from the review. Four trials were excluded because they studied pelvic drainage following hysterectomy and pelvic lymphadenectomy, with no inguinal lymph node dissection (Lopes 1995; Patsner 1995; Franchi 1997; Franchi 2007). Two trials looked at pelvic drainage following extended pelvic lymphadenectomy for urological conditions, where the extent of dissection was superior to Cloquet’s node, with no inguinal node dissection (Danuser 2013; Ozdemir 2013). One trial looked at para‐aortic drainage following para‐aortic lymphadenectomy for gynaecological cancer, with no inguinal lymph node dissection (Morice 2001). One study looked at vascular groin dissections, where no lymph nodes were removed (Youssef 2005).

Risk of bias in included studies

We identified no trials eligible for inclusion, therefore we cannot comment on risk of bias.

Effects of interventions

We could not determine the effect of wound drainage following groin dissection for malignant disease in adults because we did not identify any eligible trials for inclusion in the review.

Discussion

Summary of main results

No eligible trials were identified for inclusion in this review, therefore it has not been possible to generate any results at this time concerning the effect of drain insertion on complications following lymphadenectomy limited to Cloquet's node as the superior limit of dissection.

Overall completeness and applicability of evidence

We identified no RCTs that were eligible for inclusion in this review, therefore the evidence regarding wound drainage following groin dissection for malignant disease is incomplete. Quasi RCTs were not eligible for inclusion in the review and whilst we could have made a decision (post hoc) to widen the inclusion criteria to include quasi RCTs we did not do this. In the event we did not identify through the search process any quasi RCTs which would have met the inclusion criteria for this review.

Quality of the evidence

As we identified no eligible trials to include in the review.

Potential biases in the review process

The potential for bias in the review process is low. Our literature search was conducted by the Cochrane Wounds Group, working to accepted standards; and included five electronic databases and three clinical trial registries. We applied no language limits to the search and are confident there was no risk of bias in the search strategy. Two review authors (DRT and HS), working independently and according to defined inclusion/exclusion criteria, were responsible for trial selection. We cannot exclude the possibility of publication bias due to non‐publication of trials, for example because papers were rejected by journal editors, or because results were non‐significant. However, because we have identified no randomised trials investigating this area, we believe journals would be likely to publish results of trials in this area, had they been conducted.

Agreements and disagreements with other studies or reviews

We have not identified any other published reviews which address this question.