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临床试验/NCT04184310
NCT04184310已完成不适用

Modified Perineal Linear Stapler Resection for External Rectal Prolapse: a Novel Approach

Zagazig University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
treatment of rectal prolapse

研究概览

简要总结

from December 2016 to July 2019, 36 elderly co-morbid patients with rectal prolapse were involved in this study which is performed in the GIT surgery unit of Zagazig University Hospital. the investigators used a modified linear stapler resection technique for the rectal prolapse. Postoperative follow up was done for one year to evaluate functional outcome, operative time, hospital stay and complications

详细描述

The study was done in the GIT Unit of the General Surgery Department of Zagazig University Hospital in the period from December 2016 to July 2019. The hospital Institutional Review Board approved the study protocol. Thirty-six old, co-morbid and short life expectancy patients were included in the sample. They were evaluated for PSP. Informed consent was signed by all patients or first-degree relatives after full discussion of the advantage and disadvantage of the operation. Preoperative bimanual examination was done for rectal prolapse to rule out enterocele or cystocele and this was confirmed by MRI. The routine preoperative evaluation was done for all patients (physical examination, complete blood tests, ECG and chest x-ray). Bowel preparation was done for all patients.

Regarding bowel function, all patients were evaluated for fecal incontinence by Wexner score and for constipation by Rome II criteria. Prophylactic intravenous cephalosporin and metronidazole was given one hour before operation. The operation was done under spinal anesthesia in the lithotomy position with slight Trendeleburg to prevent trapping of abdominal organs between walls of rectum. All operations were done by the same surgical members of the unit. Hospital stay, Intraoperative and postoperative complications were recorded. All patients started oral fluids in the second day. Follow up was done for patients every 1,3,6,9 and 12 months in the outpatient clinic.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
48 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •complete rectal prolapse
  • •co-morbid ASA I to III

排除标准

  • 未提供

研究组 & 干预措施

old patient with rectal prolapse

Experimental

old co-morbid patient with complete rectal prolapse unfit for abdominal operation

干预措施: Modified perineal linear stapler resection for external rectal prolapse (Other)

结局指标

主要结局

treatment of rectal prolapse

时间窗: 30 dyas

patients satisfaction after operation - no mass coming form anus - no previous complications like bleeding and constipation

次要结局

  • post operative complications(one year)

研究者

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

osama khalil

assistant profeosser

Zagazig University

研究点 (1)

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