Marianne Djernes Lautrup1, Jorn Bo Thomsen2, René Depont Christensen3, Christina Kjaer4. 1. Department of Surgery, Lillebaelt Hospital, Beriderbakken 4, 7100, Vejle, Denmark. Electronic address: Marianne.korsgaard@dadlnet.dk. 2. Department of Plastic Surgery, Lillebaelt Hospital, Beriderbakken 4, 7100, Vejle, Denmark; Odense University Hospital, J.B. Winslows Vej 4, 5000, Odense C, Denmark. Electronic address: jornbothomsen@gmail.com. 3. Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark. Electronic address: depont42@gmail.com. 4. Department of Surgery, Lillebaelt Hospital, Beriderbakken 4, 7100, Vejle, Denmark. Electronic address: Christina.kjaer1@rsyd.dk.
Abstract
BACKGROUND: Breast cancer is the most common cancer in Danish women. In 2016 about 1450 (31%) Danish breast cancer patients had a mastectomy. The aim was to compare the frequency of postoperative complications in two methods of surgery, electrocautery dissection and tumescent technique, when performing a mastectomy. METHODS: Open randomized controlled trial of all consecutive primary breast cancer or DCIS female patients who underwent either asimple mastectomy or a modified radical mastectomyin Vejle Hospital, from January 2012 to October 2017. Primary outcomes were seroma production, bleeding, infection and necrosis. Secondary outcomes were duration of surgery and delay of adjuvant treatment caused by complications. Categorical outcome variables were compared between randomization groups using chi-square of Fisher exact test and continuous outcome variables by using Wilcoxon rank test. All analyses were performed at a 5% two-sided significance level. RESULTS:357 patients met the inclusion criteria. 14 had bilateral mastectomy, i.e. 371 breasts. The two randomization groups consisted of 105 patients/107 breasts operated by tumescent technique and 98 patients/102 breasts operated by electrocautery technique. Tumescent technique produced more seroma though not significant (p = 0.631) (mean 605 vs. 630 ml). Bleeding in the tumescent group was 10.3% vs. 5.9% in the electrocautery group (p = 0.245). Infection (5.9% vs. 7.5% p = 0.645) and necrosis (4.9% vs. 4.7% p = 0.938) was uncommon with no difference between the intervention groups. Infection was most common cause of delay of adjuvant treatment; 3.9% in the electrocautery technique group. No significant difference in duration of surgery (p = 0.392). CONCLUSION: Both techniques are equally safe for simple and modified radical mastectomy.
RCT Entities:
BACKGROUND:Breast cancer is the most common cancer in Danish women. In 2016 about 1450 (31%) Danish breast cancerpatients had a mastectomy. The aim was to compare the frequency of postoperative complications in two methods of surgery, electrocautery dissection and tumescent technique, when performing a mastectomy. METHODS: Open randomized controlled trial of all consecutive primary breast cancer or DCIS female patients who underwent either a simple mastectomy or a modified radical mastectomy in Vejle Hospital, from January 2012 to October 2017. Primary outcomes were seroma production, bleeding, infection and necrosis. Secondary outcomes were duration of surgery and delay of adjuvant treatment caused by complications. Categorical outcome variables were compared between randomization groups using chi-square of Fisher exact test and continuous outcome variables by using Wilcoxon rank test. All analyses were performed at a 5% two-sided significance level. RESULTS: 357 patients met the inclusion criteria. 14 had bilateral mastectomy, i.e. 371 breasts. The two randomization groups consisted of 105 patients/107 breasts operated by tumescent technique and 98 patients/102 breasts operated by electrocautery technique. Tumescent technique produced more seroma though not significant (p = 0.631) (mean 605 vs. 630 ml). Bleeding in the tumescent group was 10.3% vs. 5.9% in the electrocautery group (p = 0.245). Infection (5.9% vs. 7.5% p = 0.645) and necrosis (4.9% vs. 4.7% p = 0.938) was uncommon with no difference between the intervention groups. Infection was most common cause of delay of adjuvant treatment; 3.9% in the electrocautery technique group. No significant difference in duration of surgery (p = 0.392). CONCLUSION: Both techniques are equally safe for simple and modified radical mastectomy.
Authors: Kristjan S Asgeirsson; J Michael Dixon; Lauren Darrigues; Benjamin Sarfati; R Douglas Macmillan Journal: Ann Surg Oncol Date: 2021-04-16 Impact factor: 5.344