Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- improvement of incontinence and / or constipation.
研究概览
简要总结
Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.
详细描述
Rectal prolapse is a disabling condition, which is more common in females and increases in frequency with age.
There are two types of rectal prolapse; external and internal. External rectal prolapse is a circumferential protrusion of all layers of the rectum through the anal sphincter. Internal rectal prolapse, also referred to as rectal intussusception.
The majority of patients with a RP suffer from symptoms of fecal incontinence and constipation, causing a significant negative impact on quality of life.
The aims of the surgical treatment are to correct the anatomical abnormality and to cure the accompanying symptoms of incontinence, constipation and pain, with the lowest rate of complications as possible and an acceptable rate of recurrence.
Since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment for RP have been applied in patients of all ages.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with rectal prolapse either external or internal prolapse
排除标准
- •Age below 18 years.
- •Pregnancy or breast-feeding.
- •Recurrence of rectal prolapse.
- •patients with previous complicated abdominal surgery.
研究组 & 干预措施
Laparoscopic anterior mesh rectopexy
A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.
干预措施: Laparoscopic anterior mesh rectopexy (Procedure)
Laparoscopic anterior mesh rectopexy
A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.
干预措施: polypropylene mesh (Device)
Laparoscopic posterior mesh rectopexy
Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical "leg" laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh "wings" will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.
干预措施: Laparoscopic posterior mesh rectopexy (Procedure)
Laparoscopic posterior mesh rectopexy
Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical "leg" laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh "wings" will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.
干预措施: polypropylene mesh (Device)
结局指标
主要结局
improvement of incontinence and / or constipation.
时间窗: 1 year postoperatively
recurrence rate
时间窗: 1 year postoperatively
次要结局
- Duration of Surgery(intraoperative)
- Peri-operative blood loss(during surgery, 1 day)
研究者
Ibrahim Mostafa Ahmed Abdel Aal
Assistant lecturer
Assiut University