Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-14
First Post:
2022-12-24
Brief Title:
Open vs Laparoscopic Repair of Perforated Peptic Ulcer
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Comparison Between Open vs Laparoscopic Repair of Perforated Peptic Ulcer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer
Detailed Description:
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 patients preoperative clinical status surgeon expertisepreference 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None