NCT05715450

Brief Summary

Use the falciform ligament flap for the treatment of perforated peptic ulcer

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started May 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
May 2023Nov 2026

First Submitted

Initial submission to the registry

September 29, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2026

Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

3.4 years

First QC Date

September 29, 2022

Last Update Submit

March 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (1)

Falciformopexy for Treatment Perforated Peptic Ulcer

OTHER

Use falciform ligament flap for repair perforated peptic ulcer

Procedure: Falciformopexy for Treatment Perforated Peptic Ulcer

Interventions

use the falciform ligament on perforated peptic ulcer

Falciformopexy for Treatment Perforated Peptic Ulcer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Any cases presented with PPU within age from 18 till 70 years.

You may not qualify if:

  • malignancy.
  • Previous GIT and liver surgery.
  • nonoperative treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 708243BACKGROUND
  • 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.

    PMID: 34188907BACKGROUND
  • 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.

    PMID: 19220208BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Doaa Hamada Abd elbaset

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doaa Hamada Abd elbaset

CONTACT

Mostafa Ahmed Hamad

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 29, 2022

First Posted

February 8, 2023

Study Start

May 30, 2023

Primary Completion (Estimated)

October 23, 2026

Study Completion (Estimated)

November 23, 2026

Last Updated

March 10, 2023

Record last verified: 2023-03