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临床试验/NCT06559085
NCT06559085招募中不适用

Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse

Assiut University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Operative time

研究概览

简要总结

Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy

详细描述

Rectal prolapse is the full-thickness prolapse of the rectum, in which the rectum passes externally beyond the anal sphincters. It is a somewhat rare condition, estimated to occur in less than 0.5% of the population. Rectal prolapse has a 9:1 female predominance, and while it is occasionally seen in younger individuals, the incidence increases with age.

Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches. Traditionally, a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients. The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years, with mesh rectopexy being the most popular procedure.

The mesh rectopexy operation was first described by Ripstein10 in 1952. Again, after mobilization of the rectum, an anterior sling of synthetic material (either absorbable or non-absorbable) is placed in front of the rectum and sutured to the sacral promontory. The rationale for this is to restore the natural curve of the rectum, which reduces the effect of downward abdominal pressure. The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent, returning the rectum to a normal anatomical position.

The act of mobilization, suture, and fibrosis keeps the rectum fixed in position as adhesions form, attaching the rectum to the presacral fascia. Although SR is considered a good option for the cure of rectal prolapse/IS in both men and women, some reviews of this procedure noted a better overall clinical outcome in men. This may be due to occult sphincter defects in women, and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 70 years.
  • Both sexes.
  • Patients with complete rectal prolapse.

排除标准

  • Unfit for surgery
  • Impaired coagulation profile
  • Contraindication of laparoscopy

结局指标

主要结局

Operative time

时间窗: Until the conclusion of the surgical procedure

Operative time will be measured (Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair)

Intraoperative injuries

时间窗: Until the conclusion of the surgical procedure

Intra operative injuries will be recorded including bowel or vascular injuries

次要结局

  • Improving of symptoms(28 days after surgery)
  • Recurrence rate(28 days after surgery)
  • Complications(28 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Mohamed Ahmed Mohamed Makhlouf

Assistant Lecturer of General Surgery, Assiut University, Assiut, Egypt

Assiut University

研究点 (2)

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