NCT06484699

Brief Summary

The aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at Sohag University Hospital. The study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

June 26, 2024

Last Update Submit

June 12, 2025

Conditions

Perforated Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

  • Early postoperative follow up for repair of perforated peptic ulcer

    resumption of oral intake

    3 days after the operation

Study Arms (2)

open repair of perforated peptic ulcer

ACTIVE COMPARATOR

group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach

Procedure: open repair of perforated peptic ulcer

laparoscopic repair of perforated peptic ulcer

ACTIVE COMPARATOR

group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach

Procedure: laparoscopic repair of perforated peptic ulcer

Interventions

open repair of perforated peptic ulcerPROCEDURE

group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach

open repair of perforated peptic ulcer
laparoscopic repair of perforated peptic ulcerPROCEDURE

group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach

laparoscopic repair of perforated peptic ulcer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with a clinical diagnosis of perforated peptic ulcer that are fit to undergo surgery either via laparotomy or laparoscopy, males or females, any age, with gastric or duodenal ulcer, with American Society of Anesthesiologists (ASA) grade I, II, III.

You may not qualify if:

  • Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
  • Patients with associated pathology other than perforated peptic ulcer.
  • Patients with American Society of Anesthesiologists (ASA) grade IV, V, VI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Lanas A, Chan FKL. Peptic ulcer disease. Lancet. 2017 Aug 5;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7. Epub 2017 Feb 25.

    PMID: 28242110BACKGROUND

  • Tarasconi A, Coccolini F, Biffl WL, Tomasoni M, Ansaloni L, Picetti E, Molfino S, Shelat V, Cimbanassi S, Weber DG, Abu-Zidan FM, Campanile FC, Di Saverio S, Baiocchi GL, Casella C, Kelly MD, Kirkpatrick AW, Leppaniemi A, Moore EE, Peitzman A, Fraga GP, Ceresoli M, Maier RV, Wani I, Pattonieri V, Perrone G, Velmahos G, Sugrue M, Sartelli M, Kluger Y, Catena F. Perforated and bleeding peptic ulcer: WSES guidelines. World J Emerg Surg. 2020 Jan 7;15:3. doi: 10.1186/s13017-019-0283-9. eCollection 2020.

    PMID: 31921329BACKGROUND

  • Lau JY, Sung J, Hill C, Henderson C, Howden CW, Metz DC. Systematic review of the epidemiology of complicated peptic ulcer disease: incidence, recurrence, risk factors and mortality. Digestion. 2011;84(2):102-13. doi: 10.1159/000323958. Epub 2011 Apr 14.

    PMID: 21494041BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Central Study Contacts

Hussam F Muhammad, Resident

CONTACT

01090272797hossamfathyshabeb@gmail.com

Ayman M Ahmad, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Department of General Surgery, Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

May 13, 2024

Primary Completion

June 25, 2025

Study Completion

June 25, 2025

Last Updated

June 15, 2025

Record last verified: 2024-06

Locations

EG(1)