COMPARISON BETWEEN LAPAROSCOPIC TRACTION (SHEHATA TECHNIQUE) AND 2-STAGE FOWLER STEPHENS ORCHIOPEXY FOR HIGH INTRABDOMINAL UNDESCENDED TESTIS. A PROSPECTIVE RANDOMIZED STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Testicular Survival Rate and Successful Scrotal Position
研究概览
简要总结
The goal of this clinical trial is to compare between laparoscopic traction (Shehata technique) with 2-Stage Fowler Stephens orchiopexy in cases of high intra-abdominal undescended testis in a prospective randomized manner to verify the results of the Shehata technique against the reference standard Fowler-Stephens Orchiopexy in fullfilling the objective of placing a high intra-abdominal testis into the ipsilateral scrotal compartment without the occurance of later atrophy or ascent on follow up.
Type of Study: Prospective randomized clinical study that conforms to the CONSORT statement guidelines [9]. Patients will be divided into 2 groups randomized by block randomization method with an intention-to treat approach into:
Group 1: Patients will undergo the Shehata Traction technique. Group 2: Patients will undergo Folwer-Stephens technique.
详细描述
Study Setting: The study will be conducted at the Department of Pediatric Surgery, Ain Shams University hospitals .
Study Period: 2 years from the approval from the Research Ethics Committee.
Study Population and CONSORT flowchart (Appendix 1)
- Inclusion Criteria:
1. Patients older than 6 months with impalpable undescended testis confirmed to be high intrabdominal testis after examination under anesthesia and laparoscopic exploration finding a testis that cannot be brought to scrotum in one stage as evidenced by failure to reach the contralateral internal inguinal ring.
- Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •- Patients older than 6 months with impalpable undescended testis confirmed to be high intrabdominal testis after examination under anesthesia and laparoscopic exploration finding a testis that cannot be brought to scrotum in one stage as evidenced by failure to reach the contralateral internal inguinal ring.
排除标准
- •Patients who underwent previous abdominal surgery (intraperitoneal surgery).
- •Recurrent cases.
- •Patients older than 6 months with impalpable undescended testis with confirmed palpable testis after examination under anesthesia.
- •Patients older than 6 months with impalpable undescended testis with associated persistent Mullarian duct remnants.
- •Patients older than 6 months with impalpable undescended testis with confirmed intrabdominal testis which can be brought to scrotum in one stage after laparoscopic exploration. (Tensionless reach
研究组 & 干预措施
Laparoscopic Traction (Shehata Technique)
Preliminary traction to lengthen the testicular vessels by applying a 3/0 Ethibond suture to the testis fixing it to abdominal wall near the contralateral Anterior Superior Iliac Spine.
The second stage will be planned after 2 weeks similar in principle to the 2nd stage Fowler - Stephens orchiopexy.
干预措施: Laparoscopic Traction (Shehata Technique) And 2-Stage Fowler Stephens Orchiopexy (Procedure)
2-Stage Fowler Stephens Orchiopexy
First Stage of Stephen Fowler Technique A 5 mm incision and port is placed in the left mid- epigastrium through with a 5 mm gasper forceps is introduced into the abdominal cavity. A 5 mm instrument is then placed in the right abdomen below the horizontal plane of umbilicus. Through this port a 5 mm endoclip applicator can be passed.
The peritoneum overlying the testicular vessels 2 cm cephalad to the testis is incised .The testicular vessels are then clipped or cauterized and divided.
When one is planning to perform orchidopexy in two stages, no dissection should be carried out in the vicinity of the testis in the first stage. The triangular leash of the peritoneum between the vas and vessels should not be dissected as it is here that a collateral circulation develops from the artery to the vas deferens and the peritoneal vessels.
Second Stage of Stephen Fowler Technique
In the second stage Stephen-Fowler procedure, again three ports are placed similar to the first stage. Now the
干预措施: Laparoscopic Traction (Shehata Technique) And 2-Stage Fowler Stephens Orchiopexy (Procedure)
结局指标
主要结局
Testicular Survival Rate and Successful Scrotal Position
时间窗: 2 years
次要结局
未报告次要终点