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临床试验/NCT04063722
NCT04063722已完成不适用

A Randomized Controlled Trial Modified Benelli Procedure For Subcutaneous Mastectomy In Gynecomastia

Al-Kindy College of Medicine0 个研究点目标入组 150 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
主要终点
prevalence of proper postoperative nipple-areolar complex position: the distance from the midclavicular point to the postoperative nipple areola complex position.

研究概览

简要总结

The study included 150 patients with gynecomastia (Grade II and III) for the period between January 2010 and January 2016 who attended private hospitals and Al- Kindy Teaching Hospital. The patients were divided into two groups according to the operative techniques used. Group A included 75 patients treated surgically with subcutaneous mastectomy using periareolar incision. Group B; included the other 75 patients who were managed by "modified Benelli technique". The subcutaneous mastectomy using "modified Benelli technique" showed a significantly lower operating time due to ample access for excision of breast tissue. Excision of excess skin allowed the areola to retain a cosmetically more acceptable position. There was a lot of pleating of the skin compared to the other technique using the periareolar incision.

详细描述

Patients with true gynecomastia, attending Al-Kindy Teaching Hospital and private hospitals, Baghdad, Iraq, from January 2010 to January 2016 were enrolled in the study. Grading of gynecomastia was done according to Cordova and Moschella classification (6). Patients with Grade I were excluded because of no skin excess, while grade IV were excluded due to the need of more extensive procedures. The study protocol was reviewed and approved by the Scientific and Ethical Committee of Al-Kindy College of medicine and Al-kindy Teaching hospital in the committee number 6 in 20-5-2019 (Ethical approval number and Date). Written informed consents were obtained from all patients as an action on acceptance. All enrolled patients were operated by the same surgeon. Patients were randomly assigned to one of the following surgical technique: Group A; included patients who underwent subcutaneous mastectomy using periareolar incision with lateral and medial extension as needed according to Webster(12).

Group B; included patients who were treated by the proposed Modified Benelli Technique (MBT) using the following operative procedure:

First ask the patient to stand up and draw the a line referring to the midline of the chest then mark the ideal breast meridian at 18 cm from midclavicular point to show the position where the nipple should be placed (point X) with skin marker pen and assess the quantity of surplus skin to be excised. After that, ask the patient to lie down on the couch and a periareolar line was marked ( line A) above and medial to the areola and a second radial line above it and parallel to it passing in the point (X) was made and named line B. The ends of this line is curved to approximate and connect to both ends of the line A . Then, the patient is given general anesthesia and the two incisions were made on the lines A and B i.e. periareolar incision above and medial to the areola with a second incision above it and connecting both ends . Next, the whole thickness of the excess skin between line A and the line B was excised (Simon classification 2A, 2B and 3) and subcutaneous mastectomy was done and sent to histopathology. Later on, bleeding control was done by good hemostasis and suction drain was put in its proper site. Finally subcuticular suturing was done by approximation of two incisions using Nylon 3/0. Lastly, sterile pressure dressing was placed. The result of both groups were compared in terms of operating time, nipple-areola complex location, post-operative complications including, pleating of the skin at suture line, hematoma, bruising at the site of incision, , soft tissue deformity, seroma, hypoesthesia of nipple-areola complex, wound dehiscence, areolar epidermolysis, and hypertrophic scarring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
17 Years 至 35 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • all patients with gynecomastia

排除标准

  • Patients with Grade I gynecomastia because of no skin excess
  • patients with grade IV due to the need of more extensive procedures

结局指标

主要结局

prevalence of proper postoperative nipple-areolar complex position: the distance from the midclavicular point to the postoperative nipple areola complex position.

时间窗: Documented on one occasion, at 6 months postoperatively.

The distance from the midclavicular point to the nipple areola complex position were measured postoperatively, with an average of 6-month follow-up, to evaluate the aesthetic appropriateness of the postoperative nipple areola complex position which should be 18-19 cm from the midclavicular point.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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