Falciformopexy for Treatment Perforated Peptic Ulcer.
Primary Purpose
Perforated Peptic Ulcer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Falciformopexy for Treatment Perforated Peptic Ulcer
Sponsored by
About this trial
This is an interventional treatment trial for Perforated Peptic Ulcer
Eligibility Criteria
Inclusion Criteria: - Any cases presented with PPU within age from 18 till 70 years. Exclusion Criteria: malignancy. Previous GIT and liver surgery. nonoperative treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Falciformopexy for Treatment Perforated Peptic Ulcer
Arm Description
Use falciform ligament flap for repair perforated peptic ulcer
Outcomes
Primary Outcome Measures
Falciformopexy for Treatment Perforated Peptic Ulcer
The aim is to decrease incidence of leakage from the perforated peptic ulcer by using the falciform ligament for repair of the perforated peptic ulcer.
Firstly, the investigator will seek to repair the perforation using suture to approximate edges then use falciform ligament as a secound layer to ensure security and prevent postoperative leakage that will lead to peritonitis and death.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05715450
Brief Title
Falciformopexy for Treatment Perforated Peptic Ulcer.
Official Title
Falciformopexy for Treatment Perforated Peptic
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2023 (Anticipated)
Primary Completion Date
October 23, 2026 (Anticipated)
Study Completion Date
November 23, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Use the falciform ligament flap for the treatment of perforated peptic ulcer
Detailed Description
Peptic ulcer perforation (PUP) is one in all the foremost common critical surgical emergencies. The omentum flap is usually wont to cover a PUP. However, the omentum can not be utilized in cases of severe peritonitis or previous surgical removal. this is often the primary study conducted in Vietnam that was designed to analyse the outcomes of patients with PUPs who were treated using the ligament.
In the population, the prevalence of ulcer disease supported physician diagnosis ranges from 0.12% to 1.50%, and hospitalization rates range from 0.10% to 0.19%. ulceration perforation (PUP) is one of the foremost common surgical emergencies worldwide, which is necessitate emergent surgical intervention.
the death rate of PUPs is between 1.3% and 20%, and mortality thanks to a perforation of a gastric ulcer is over mortality because of a perforation of a duodenal ulcer (40% vs 10%) . Some studies have shown that having comorbidities, being over 70 years old, undergoing surgical procedure after 36 h, PUP diameter greater than 1 cm2 and postoperative com- plications are associated with mortality. The technique of using the omental patch for repair PUP is commonest now thanks to mobility and vascularity but is also using the falciform ligament in some cases due to highly vascularity.
The technique of using the falciform ligament for the treatment of PUPs was reported in 1978 by Fry . The purpose of the study was to explain the technique and therefore the results of using the falciform ligament for the treat- ment of PUPs during a large volume surgical centre in Assuit university hospital found the falciform patch to be a successful technique in repair PUP and is assumed to be as effective as omental patch but more advantage because of highly vascular.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Peptic Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Falciformopexy for Treatment Perforated Peptic Ulcer
Arm Type
Other
Arm Description
Use falciform ligament flap for repair perforated peptic ulcer
Intervention Type
Procedure
Intervention Name(s)
Falciformopexy for Treatment Perforated Peptic Ulcer
Intervention Description
use the falciform ligament on perforated peptic ulcer
Primary Outcome Measure Information:
Title
Falciformopexy for Treatment Perforated Peptic Ulcer
Description
The aim is to decrease incidence of leakage from the perforated peptic ulcer by using the falciform ligament for repair of the perforated peptic ulcer.
Firstly, the investigator will seek to repair the perforation using suture to approximate edges then use falciform ligament as a secound layer to ensure security and prevent postoperative leakage that will lead to peritonitis and death.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Any cases presented with PPU within age from 18 till 70 years.
Exclusion Criteria:
malignancy.
Previous GIT and liver surgery.
nonoperative treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa Hamada Abd elbaset
Phone
01028971942
Email
dhamada755@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Ahmed Hamad
Phone
+201222438186
Email
mostafa_hamad@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa Hamada Abd elbaset
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
708243
Citation
Fry DE, Richardson JD, Flint LM Jr. Closure of an acute perforated peptic ulcer with the falciform ligament. Arch Surg. 1978 Oct;113(10):1209-10. doi: 10.1001/archsurg.1978.01370220095016.
Results Reference
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PubMed Identifier
34188907
Citation
Son TQ, Hoc TH, Huong TT, Long VD, Tung TT, Quyet NC, Panha L, Van Chi N. Outcomes of surgical management of peptic ulcer perforation using the falciform ligament: A cross-sectional study at a single centre in Vietnam. Ann Med Surg (Lond). 2021 Jun 16;67:102477. doi: 10.1016/j.amsu.2021.102477. eCollection 2021 Jul.
Results Reference
background
PubMed Identifier
19220208
Citation
Sung JJ, Kuipers EJ, El-Serag HB. Systematic review: the global incidence and prevalence of peptic ulcer disease. Aliment Pharmacol Ther. 2009 May 1;29(9):938-46. doi: 10.1111/j.1365-2036.2009.03960.x.
Results Reference
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Falciformopexy for Treatment Perforated Peptic Ulcer.
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