|Year : 2019 | Volume
| Issue : 3 | Page : 73-77
Effect of flap-fixation on seroma formation after mastectomy among African patients: A single centre randomized study
Ibrahim U Garzali1, Amina I El-Yakub2, Abdulrahman A Sheshe2
1 Department of Surgery, Abubakar Tafawa Balewa University Teaching Hospital, Bauchi, Nigeria
2 Deparment of Surgery, Aminu Kano Teaching Hospital, Kano, Nigeria
|Date of Submission||06-Mar-2020|
|Date of Acceptance||27-Apr-2020|
|Date of Web Publication||23-Sep-2020|
Dr. Ibrahim U Garzali
Department of Surgery, Abubakar Tafawa Balewa University Teaching Hospital, Bauchi
Source of Support: None, Conflict of Interest: None
Background: Breast cancer is the most common in female malignancy world-wide with about 1 million new cases per year. Surgeons play a major role in the management of breast cancer with mastectomy constituting the most common and important surgical intervention needed for these patients especially in our setting. Seroma constitute most common complication of mastectomy with some surgeons now considering it a side effect of the surgery rather than a complication. The objective of this study was to determine the role of flap-fixation on seroma formation after mastectomy in Aminu Kano Teaching Hospital.
Patients and Methods: This was a single Centre prospective study carried out from August 2017 to September 2018 with the studied population being women with breast cancer undergoing mastectomy. Recruitment was at the surgical outpatient clinic. The patients were randomized into two groups with group A having flap fixation after mastectomy and group B having conventional closure with no flap fixation. Seroma formation was then compared within the two groups.
Results: A total of 60 patients were involved in the study with 30 patients per group. The mean age of patients is 44.2 ± 6.1 for group A and 46.3 ± 7.4 in group B. Majority of the patients had modified radical mastectomy with prolongation of the surgery by up to 20 min in group A. The duration of drainage, amount of fluid drained and incidence of seroma was higher in group B.
Conclusion: Flap fixation to pectoralis major significantly reduces seroma formation after mastectomy for breast cancer.
Keywords: Breast cancer, flap-fixation, mastectomy, seroma
|How to cite this article:|
Garzali IU, El-Yakub AI, Sheshe AA. Effect of flap-fixation on seroma formation after mastectomy among African patients: A single centre randomized study. Arch Int Surg 2019;9:73-7
|How to cite this URL:|
Garzali IU, El-Yakub AI, Sheshe AA. Effect of flap-fixation on seroma formation after mastectomy among African patients: A single centre randomized study. Arch Int Surg [serial online] 2019 [cited 2020 Nov 26];9:73-7. Available from: https://www.archintsurg.org/text.asp?2019/9/3/73/295919
| Introduction|| |
Breast cancer is the most common malignancy in females world-wide with about 1 million new cases per year. It has overtaken cancer of the cervix at Ibadan cancer registry two decades ago and is now the most common female malignancy in all parts of Nigeria.,, More than a million cases of breast cancer are diagnosed worldwide every year, whereas about 400 new cases are diagnosed in Korle bu hospital, Ghana. In 2013, the incidence of breast cancer in Sokoto, Nigeria was placed at 7.4 per 100,000 women per annum.
Management of breast cancer is a multi-specialty team endeavor requiring the expertise of surgeons, radiation-oncologist among others. The surgeons play a central role, being involved in prevention, screening, diagnosis, and treatment. Most common and important surgical intervention to cure or palliate breast cancer especially in low resource setting is mastectomy. In the developed world, breast conserving surgeries are done but this is rarely applicable in our setting due to lack of screening plan, late presentation of most patients, large size of the tumor, limited access to radiotherapy and inefficient follow-up programs.
Prevention of postmastectomy seroma has been studied for decades and still, no satisfactory measure is available. Various techniques of prevention that were studied include preoperative administration of tranxemic acid, intraoperative dead space obliteration and firm dressing with axillary pad, and postoperative prolonged drainage of more than 10 days and shoulder immobilization.,,, Dead space obliteration by flap fixation to the chest wall after mastectomy has shown promise in reducing postmastectomy seroma. The first effort at flap fixation was in 1913 when Halsted obliterated the dead space beneath the clavicle after mastectomy., In 1951, Orr used tension suturing to tack the skin flaps to the chest wall after mastectomy while in 1953, Keyes et al. used through and through suture to tack the flaps to the chest wall to obliterate the space.,
This study was aimed at identifying the role of dead space obliteration by flap fixation on postmastectomy seroma formation at Aminu Kano Teaching Hospital with the hope of modifying the current practice, thereby reducing seroma formation and the duration of hospital stay among patients undergoing mastectomy.
| Patients and Methods|| |
This is a prospective study which was conducted on a random sample of 60 female patients with breast carcinoma scheduled for modified radical mastectomy. The patients were divided into 2 groups, the study group A with flap fixation (30) and the control group B (30). The study was carried out in department of surgery, Aminu Kano Teaching Hospital, Kano, northwest Nigeria.
| Protocol for Patient Recruitment|| |
Patients were recruited at the surgical outpatient clinic and data were collected by an interviewer administered structured questionnaire which was administered preoperatively to reflect the bio data, serial number, age, hypertension, diabetes, obesity, stage of the disease, grade and receptor status, preoperative radiotherapy or chemotherapy. The size of the tumor was measured using electronic digital caliper (EA gems, model number DCLA-0605) with a resolution of 0.1 mm/0.01 inch, accuracy of ±0.2 mm/0.01 inch.
The patients were randomly divided into two groups by computer generated random number with odd number indicating patients belonging to the flap fixation group (Group A), whereas even number indicating patients belonging to nonflap fixation group (Group B). There were 30 patients recruited in each group. The randomization was done once patient is in the theatre.
| Protocol for Surgery|| |
Surgery was done under general anesthesia and endotracheal intubation with a dose of 1g Ceftriazone administered at induction of anesthesia. Mastectomy was performed via an elliptical skin incision encompassing the tumor, biopsy site, overlying skin, and the nipple-areola complex. The incision was deepened to the subcutaneous tissue. The flap was now raised to the clavicle above, upper part of the rectus below, midline of the sternum medially and anterior border of the lattissimus dorsi laterally. Finally, the whole of the posterior aspect of the breast was dissected from the pectoralis major from medial to lateral extending into the axilla and axillary lymph nodes cleared before hemostasis secured. Once the breast tissue is removed, the weight of the tissue in grams was measured using Fazzini Hanging scale with a capacity of 25 kg and graduation of 100 g.
The study addresses the type of wound closure in mastectomy. So, only wound closure was different between the two groups. In the flap fixation group; after completing the mastectomy, closed suction drain in the form of RomoVac Set was inserted beneath the flaps. Vicryl 2/0 suture was then used to place multiple alternating stitches, 5 cm apart, between the subcutaneous tissues of the skin flaps and the underlying pectoralis major muscle at various parts and wound closed in a simple interrupted fashion using nylon 2/0. In the nonflap fixation group (Group B); after mastectomy, closed suction drain in the form of RomoVac Set was inserted beneath the flap and wound was closed in a simple interrupted fashion using nylon 2/0. Patients and tumor characteristics and operation related factors like duration of surgery (From skin incision to the last skin stitch).
| Protocol for Post Operative Data Collection|| |
The unit policy dictates that all patients are kept on admission until drains are removed. The drained fluid was emptied and recorded daily. The drain was removed when the effluent became <50 mls over the previous 24 h. Seroma was detected by clinical evaluation at day five or ten after removal of drain. If seroma is not detected clinically, local chest wall ultrasound over the flaps was done 14 days after drain removal to document or exclude the presence of seroma. The ultrasound was done in radiology department using B mode, high resolution, 7.5 MHz probe.
In assessing the severity of seroma, the Common Terminology Criteria for Adverse Events v3.0 grades seroma as follows:
- Grade 1 if asymptomatic (detected by ultrasound scan, no treatment needed)
- Grade 2 if symptomatic (detected clinically, simple aspiration indicated)
- Grade 3 if symptomatic (interventional radiology or operative intervention indicated).
The total amount and duration of drained fluid was recorded. The presence or absence of seroma was recorded in each group and the result was compared between the two groups and the effect of flap fixation on the amount of fluid drained, duration of fluid drainage and formation of seroma was concluded.
| Results|| |
A total of 60 patients participated in the study with 30 patients per group. The clinical characteristics of the patient in each group are summarized in [Table 1]. The mean age of patients in group A (flap fixation) is 44.2 ± 6.1 years which was close to the mean age of 46.3 ± 7.4 years in group B (nonflap fixation). About 57% of patient in group A are found to have normal body mass index compared to 63% of the group B patients. Hypertension was the commonest comorbidity in both groups; 50% of group A patients are hypertensive compared with 57% of group B. No statistically significant difference was recorded between the groups regarding demographic characteristics. These are summarized in [Table 1].
Only 3 patients had simple mastectomy and sentinel lymph node biopsy, the remaining 57 all had modified radical mastectomy. The mean weight of the specimens was not different in both groups. However, the operative time was significantly prolonged by up to 21 min in group A with a P value <0.0001. These are summarized in [Table 2].
On the first day postoperatively, the amount of fluid drain in group A was about 154 ± 14.32 mls as oppose to 300 ± 30.67 mls of group B. This difference was also reflected in days 2, 3, and 4 or more post operatively. The difference was statistically significant. The mean duration of drainage in group A was 4.2 ± 2.1 days as compared to 8.7 ± 2.4 days of group B. This was significant with a P value of <0.0001 [Table 3].
| Post Mastectomy Seroma in Both Groups|| |
Post mastectomy seroma formation was significantly different in both groups with 27% of patients in group A and 57% in group B developing seroma (P = 0.02) [Table 4]. The grade of seroma also varies with up to 63% of seroma in group A detected only by ultrasound and requiring no aspiration whereas only 47% of seroma in group B are detected by ultrasound. The amount of aspiration required for resolution of seroma is also different in the two groups with the group A patients requiring a single aspiration while the group B seroma requires up to 3 aspirations. The overall incidence of seroma in the study is 42%; however, only 20% requires aspiration. Only one patient in Group A developed flap necrosis while 4 patients in group B developed flap necrosis.
|Table 4: Incidence and treatment of seroma in both groups including other complications|
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| Discussion|| |
In this study, we realized that flap fixation increased operation time by about 20 min which is statistically significant. This is buttressed by findings of Renjin et al., Haroun et al., Ozaslan et al., and Habashy et al. that noticed increase in operation time by 1020 min.,,, However, El-sisi et al., Dezhi-Chen et al. and Jabir et al. found that flap fixation did not significantly increase the time of the surgery.,, The difference may be attributed to the definition of operation time. In our study, we start timing from incision to the last stitch. These studies did not provide definition of operation time and whether or not anesthesia is part of it.
In this study, we found that post-operative drainage volume was reduced significantly if patient had flap fixation. This is similar to the findings of Habashy et al. and Jabir et al. in Egypt., This is also supported by Madhu et al. in India.,, The duration of drainage in our study differs in the two groups: those with flap fixation drained for an average of 4 days compared to 7 days of the non-flap fixation group. This is similar to studies of El-sisi et al. in Egypt who reported reduction from 16 days to 10 days after flap fixation or Haroun et al. that reported reduction from 13 days to 5 days after flap fixation., Other studies by Renjin et al. and Jabir et al. reported reduction from 18 days to 12 days after flap fixation and 20 days to 12 days after flap fixation respectively.,
In comparing flap fixation and non-flap fixation in developing postmastectomy seroma among women in Aminu Kano Teaching Hospital, it was found that flap fixation reduces seroma formation from 57% in group B to 27% in group A with a P value of 0.02. This is a statistically significant difference. Also reduced is the number of aspirations needed for seroma to resolve. In group A, a single aspiration usually results in resolution while in group B; about 3 aspirations are required before resolution. Other complications tend to be commoner in the group B having 4 cases of flap necrosis compared to one in thegroup A. These findings were supported by studies by Sakkary et al., who noticed reduction of seroma from 40% to 10% after flap fixation. Ozaslan et al. also noticed a reduction from 24% to 12%, whereas Haroun et al. recorded a reduction from 50% to 20%., Jabir et al. in Egypt and Mannu et al. in Norwich recorded reduction from 30% to 10% and 69% to 28%, respectively., Van Bastelaar and colleagues noted a reduction from 59% to 35% in a multi-center retrospective study in Netherlands. Some meta-analysis also supported these findings.,,,
| Conclusion|| |
The results obtained in this study reveals that, fixing flap to pectoralis major significantly reduce seroma formation after mastectomy among women with breast cancer. In addition, if the seroma forms, it resolves from a single aspiration.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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