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临床试验/NCT05767320
NCT05767320已完成不适用

Comparison Between Open vs Laparoscopic Repair of Perforated Peptic Ulcer

Assiut University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月15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
40
试验地点
2
主要终点
short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time

研究概览

简要总结

comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer

详细描述

With the advent of proton pump inhibitors and Helicobacter pylori (H. pylori) eradication therapy, surgical intervention for peptic ulcer disease (PUD) is limited to perforated ulcers in the emergent setting. Perforation is an acute life threatening complication of PUD and occurs in nearly 20% of cases of duodenal ulcer patients . Perforation is a common complication of PUD, with an average 2-14% of peptic ulcers resulting in perforation .While bleeding is the most frequent complication of PUD, perforation carries a higher rate of surgical intervention and is the most lethal complication, associated with a 30-days mortality risk ranging from 3-40%, with advanced age, higher American Society of Anesthesiologists (ASA) classification , elevated body mass index (BMI), and perforation diameter being non-modifiable risk factors associated with increased mortality .The only modifiable risk factor associated with mortality is time to operation, whereby a delay of more than three hours is associated with a doubling of mortality risk .In the 1990s, laparoscopic repair of PPUs was first described . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy .Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair . The choice of surgical technique, laparoscopy versus laparotomy, varies depending on the patient's preoperative clinical status, surgeon expertise/preference, and location of defect, with the goal of short operative time. It has been widely reported that open abdominal surgery increases postoperative pain and is associated with higher morbidity (ventral incisional hernia rate, surgical site infection, postoperative respiratory compromise, delayed recovery times, and dehiscence) when compared to laparoscopic surgery . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy. Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair .Despite these favorable outcomes, laparoscopic repair is less commonly used, owning to longer operative times in less experienced centers, higher incidence of reoperations owning to leakage at the repair site, and higher incidence of intraabdominal fluid collections secondary to inadequate lavage and the requirement of extensive surgical skill . Additionally, others point to laparotomy as the better treatment, especially for repairing ulcers larger than 9 mm.

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
17 Years 至 69 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 16 years old and younger than 70 years old.
  • Patients presenting with acute abdomen due to perforated peptic ulcer
  • Patients eligible for laparoscopic surgeries

排除标准

  • Patients younger than 16 years old and older than 70 years old
  • Contraindications to laparoscopic surgeries as (Hemodynamic instability/shock, Acute intestinal obstruction with dilated bowel loops, Increased intracranial pressure, Relative contraindications, Cardiac failure, Pulmonary failure, Pregnancy/large pelvic masses, Soft tissue infection at port sites, Expected (extensive) adhesions from a previous abdominal surgery)
  • Patients who absconded or left the study or died during the period of study.
  • Patients with a surgical diagnosis other than perforated peptic ulcer

结局指标

主要结局

short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time

时间窗: baseline

comparison of operative time of both laparoscopic and open surgical repair of perforated peptic ulcer

short term outcomes of both open and lap. Repair of perforated peptic ulcer; repair site leakage

时间窗: baseline

comparison of repair site leakage between both lap. and open surgical repair of perforated peptic ulcer by follow up through drains inspection.

short term outcomes of both open and lap. Repair of perforated peptic ulcer; intra-abdominal abscess

时间窗: baseline

comparison of intra-abdominal abscess formation between both lap. and open surgical repair of perforated peptic ulcer by follow up through abdominal ultrasonography.

short term outcomes of both open and lap. Repair of perforated peptic ulcer; surgical site infection

时间窗: baseline

comparison of surgical site infection between both lap. and open surgical repair of perforated peptic ulcer through daily dressing and wound inspection for signs of inflammation.

short term outcomes of both open and lap. Repair of perforated peptic ulcer; postoperative ileus

时间窗: baseline

comparison of postoperative ileus between both lap. and open surgical repair of perforated peptic ulcer by follow up of bowel movements.

short term outcomes of both open and lap. Repair of perforated peptic ulcer; hospital stay

时间窗: baseline

comparison of duration of patient's hospital stay between both lap. and open surgical repair of perforated peptic ulcer.

次要结局

未报告次要终点

研究者

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

Mina Magdy Dawood

Principal Investigator

Assiut University

研究点 (2)

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