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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforated Peptic Ulcer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 29, 2022
    Last Updated
    March 9, 2023
    Sponsor
    Assiut University
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    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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