Wound drainage after axillary dissection for carcinoma of the breast
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The objective of this review is to determine the effectiveness of wound drainage on the prevalence of seroma formation in patients following surgery for breast cancer where axillary dissection was performed.
Background
Breast cancer is one of the most frequent malignant neoplasms in women, and surgical treatment is the most relevant option for the loco‐regional control of this disease (Anderson, 2006). Axillary dissection (or removal of lymph nodes from the armpit area) is frequently performed on patients with carcinoma of the breast (Axelsson, 2007). Sentinel lymph node biopsy is a minimally invasive alternative procedure to axillary dissection that is used to stage breast cancer in clinically node‐negative patients; this procedure could be associated with a reduction in postoperative morbidity (Mansel, 2007). Axillary dissection is associated with the development of postoperative morbidity such as seroma, hematoma, arm swelling and numbness (mainly in the upper and inner aspect of the affected arm). Nevertheless, the risks and complications of level I and II axillary dissection must be weighed against the low probability of axillary nodes with a tumor (Morrow, 2002). The development of a seroma (a pocket of clear serous fluid following surgery) has been reported in 10% to 52% of cases (McCaul, 2000).
A number of factors influence the formation of seromas. These include the presence of tumor‐infiltrated axillary lymphatic nodes, the size of the lymphatic interruption after surgery, a history of previous biopsies, the size of the breast and the residual cavity, the surgical technique used (mastectomy or lumpectomy), the use of electrocautery, the time that the drainage aspirative was used and cicatrization (the process of wound healing through producing scar tissue) (Kuroi, 2005; Pogson, 2003; Stehbens, 2003).
The presence of seromas can impact on patient satisfaction in the postoperative period and can lead to the need for medical intervention for treatment. In some cases, repeated aspirations and even surgical draining may be required, thus increasing the risk of infection, skin flap necrosis, prolonged hospital stay and a delay in the commencement of chemotherapy or radiotherapy, or both (Hashemi, 2004).
Therapeutic approaches to prevent the formation of seromas include external compression, immobilization of the ipsilateral extremity (the arm on the same side as the surgery) and the use of wound drainage by means of a tube (multiple hole type versus multiple channel type) and a device that acts with closed suction or passive drainage, all of which have had less than satisfying results (Pogson, 2003).
Closed suction drainages have been traditionally used after surgery for carcinoma of the breast in the postoperative period to reduce the frequency of the formation of seroma. However, this concept has been challenged by several authors who have proposed that the clinical course of the formation of seroma is not modified with the use of drainage (Classe, 2006; Talbot, 2002). On the other hand, other studies show that the patients who do not use drainage have seromas of greater volume which last longer and require more procedures for drainage (Soon, 2005). In dealing with a subject where there is controversy, it is important to determine the effectiveness of the use of drains in reducing the prevalence of seroma formation in women following surgery for cancer of the breast where axillary dissection was performed.
Objectives
The objective of this review is to determine the effectiveness of wound drainage on the prevalence of seroma formation in patients following surgery for breast cancer where axillary dissection was performed.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) comparing wound drainage versus no wound drainage in patients following surgery for carcinoma of the breast where axillary dissection was performed.
Types of participants
Women treated for carcinoma of the breast where an axillary dissection was performed.
Types of interventions
Use versus non‐use of closed aspirative drainage after axillary dissection for carcinoma of the breast.
Types of outcome measures
Primary outcome measure
Incidence of seroma formation
Secondary outcome measures
Quantity of fluid aspirated
Frequency and duration of seroma aspirations
Type of surgery (mastectomy or lumpectomy)
Incidence of microbiologically confirmed wound infections
Incidence of wound hematomas
Rate of healing of wounds
Lenght of hospital stay
Quality of life (measured with validated tools)
Search methods for identification of studies
(1) Electronic searches
(a) The Cochrane Breast Cancer Group Specialised Register will be searched (details of search strategies used by the group for the identification of studies and the procedure used to code references are outlined in the group's module at http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/BREASTCA/frame.html). Studies including the text words 'mastectomy', 'lumpectomy', 'breast surgery', 'axillary dissection', 'wound drainage', 'suction', 'axillary', 'lymph node', 'seroma', 'lymph gland' or 'dressing' on the Specialised Register will be extracted for consideration.
(b) The Cochrane Wounds Group Specialised Register will be searched using the following search string in Procite ("axillary dissection" OR "breast cancer" OR "breast neoplasms" OR "breast neoplasm" OR (breast AND carcinoma) ) AND drain* AND ("wound infection" OR "surgical wound dehiscence" OR "cicatrix" OR "skin abscess") (details of search strategies used by the group for the identification of studies and the procedure used to code references are outlined in the group's module at http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/WOUNDS/frame.html).
(c) MEDLINE
The search strategy for "breast neoplasms" as outlined by the Cochrane Breast Cancer Group will be applied to the entire MEDLINE database (from 1966) (details of search strategies in http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/BREASTCA/frame.html.
Data collection and analysis
Assessing trials for eligibility
Two authors will independently determine the eligibility of a study . They will analyze the titles and the abstracts of all the citations found through the search strategy previously described. A copy of the full article for each reference reporting a potentially eligible trial will be obtained and assessed by the two authors. The results section (and any other area where results may appear) will be masked during assessment of a trial's eligibility. Two authors will independently apply the eligibility criteria and any discrepancies will be resolved by a third author. Full details of the eligible studies will be obtained. Where necessary, and possible, additional information will be sought from the principal investigator of the trial concerned. Any exclusions from the review of a potentially eligible trial will be justified in the final report.
Quality assessment of included studies
Assessment of quality will be based on the Schulz criteria (Schulz, 1995).
1. Was the study described as randomised?
2. Generation of allocation sequences.
3. Concealment of treatment allocation schedule.
4. Was the trial blinded/masked?
5. Inclusion of all randomised participants in analysis (ie intention‐to‐treat analysis).
Two authors will independently evaluate the methodologic quality of the studies that meet the selection requirements (a third author will resolve any discrepancies regarding quality). Sensitivity analyses will be conducted to evaluate the effect of study quality on the estimates of treatment effect. Studies of poor methodologic quality will be included and then excluded from the analysis to determine whether they modify the estimate of treatment effect.
Data extraction
At least two authors will independently extract the data for each included study using an ad‐hoc instrument. The data will be extracted according to the details of the trial (first author, year of publication, journal, publication status, period and country of study, sources of funding, study design, sample size); patient characteristics (age, sex, stage of disease, type of surgery and prior treatment status); quality of the study; details of the intervention (relating to the use or non‐use of a drain); the clinical variables related to patient well‐being and to health care; the source of financing; the duration of follow up; and the outcomes. A third author will be used to resolve any discrepancies regarding data extraction.
If the results of an RCT have been published but information on the outcome of interest has not been reported, an attempt will be made, whenever possible, to contact the trialists for the missing information. All efforts made to obtain additional will be reported in the completed review. On the other hand, if the results of an RCT have not been published but the quality of the data is relevant, those data will be collected, where possible. It will be stated in the discussion section of the review which data come from unpublished trials.
Analysis
Data will be extracted from included studies and checked by two authors. We will involve a statistical consultant as part of the review team and additional statistical guidance will be obtained by contacting the Cochrane Breast Cancer Group coordinator where there are problems or differing opinions within the team. The most complete dataset feasible will be assembled.
1. Results of eligible studies will be statistically synthesised (meta‐analysis), if appropriate and possible, using the statistical software, Review Manager 4.2.
2. Where possible, all analyses will be by intention to treat.
3. Effect size
a. For dichotomous variables, the relative risk with 95% confidence intervals will be calculated using the fixed‐effect model.
b. For continuous variables, weighted mean differences with 95% confidence intervals will be calculated using the fixed‐effect model.
4. Heterogeneity between trial results will be considered and tested where appropriate. Chi‐square tests for heterogeneity will be used to test for gross statistical heterogeneity between all trials. If heterogeneity exists, the following techniques will be undertaken to attempt to explain and resolve it:
a. subgroup analyses;
b. sensitivity analyses;
c. analysis using the random‐effects model
5. If there are sufficient trials of adequate size it may be possible to conduct subgroup analyses. Ability to conduct the analyses will also depend on whether or not the required information is recorded in the trial publications. The following will be considered for possible subgroup analysis:
a. type of drain used (with or without aspiration);
b. type of surgery performed (mastectomy or lumpectomy).
6. We will perform sensitivity analyses to evaluate the effect of study quality on the estimates of treatment effect.
