Perforated Duodenal UlcerNCT07893951
Comparison of Open vs Laparoscopic Repair of Perforated Duodenal Ulcer
A study testing Laparoscopic Repair of Perforated Duodenal Ulcer and Open Repair of Perforated Duodenal Ulcer in people with Perforated Duodenal Ulcer, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare open and laparoscopic repair of perforated duodenal ulcer in terms of postoperative outcomes. A total of 134 patients will be randomly allocated into two groups: Group A will undergo laparoscopic repair and Group B will undergo open repair. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Perforated Duodenal Ulcer
- What is being tested?
- Laparoscopic Repair of Perforated Duodenal Ulcer and Open Repair of Perforated Duodenal Ulcer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Either gender
- age 18-60 years
- Diagnosis of perforated duodenal ulcer( as per operational definitions)
Who cannot join
- patients with radiological signs of air under the diaphragm but no clinical signs of peritonitis
- patients with sealed perforation
- Patients with shock having systolic blood pressure of less than 90mmhg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Allied hospital-1 Faisalabad
Faisalābad, Punjab Province, 38000
Allied hospital-1 Faisalabad Allied hospital-1 Faisalabad, 009241-9210095, ms.ah.fsd@punjab.gov.pk
About this study
This randomized controlled trial aims to compare open and laparoscopic repair of perforated duodenal ulcer in terms of postoperative outcomes. A total of 134 patients will be randomly allocated into two groups: Group A will undergo laparoscopic repair and Group B will undergo open repair. The study will evaluate and compare postoperative outcomes between the two surgical approaches.
- Conditions
- Perforated Duodenal Ulcer
- Being tested
- Laparoscopic Repair of Perforated Duodenal Ulcer, Open Repair of Perforated Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Repair of Perforated Duodenal UlcerProcedure or surgery
Laparoscopic repair of perforated duodenal ulcer according to the standard operative technique.
Open Repair of Perforated Duodenal UlcerProcedure or surgery
Open surgical repair of perforated duodenal ulcer according to the standard operative technique.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic repair | Experimental | Not described Receives: Procedure: Laparoscopic Repair of Perforated Duodenal Ulcer |
| Open repair | Active comparator | Not described Receives: Procedure: Open Repair of Perforated Duodenal Ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of bowel function
The return of bowel function will be assessed based upon the time interval from completion of surgery until appearance of bowel sounds and passage of first flatus by the patient.
Measured: From completion of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated Duodenal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mohammad Nabi, Allied Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893951
- Sponsor's protocol ID
- SGR-2023-035-15200
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open vs Laparoscopic Repair of Perforated Duodenal Ulcer
- ClinicalTrials.gov ID
- NCT07893951
- Acronym / sponsor ID
- SGR-2023-035-15200
- Conditions
- Perforated Duodenal Ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to compare open and laparoscopic repair of perforated duodenal ulcer in terms of postoperative outcomes. A total of 134 patients will be randomly allocated into two groups: Group A will undergo laparoscopic repair and Group B will undergo open repair. The study will evaluate and compare postoperative outcomes between the two surgical approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic repair | Experimental | Procedure: Laparoscopic Repair of Perforated Duodenal Ulcer |
| Open repair | Active comparator | Procedure: Open Repair of Perforated Duodenal Ulcer |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Either gender
- age 18-60 years
- Diagnosis of perforated duodenal ulcer( as per operational definitions)
Key exclusion criteria (3 listed)
- patients with radiological signs of air under the diaphragm but no clinical signs of peritonitis
- patients with sealed perforation
- Patients with shock having systolic blood pressure of less than 90mmhg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Repair of Perforated Duodenal UlcerLaparoscopic repair of perforated duodenal ulcer according to the standard operative technique. | Procedure or surgery | Laparoscopic repair |
| Open Repair of Perforated Duodenal UlcerOpen surgical repair of perforated duodenal ulcer according to the standard operative technique. | Procedure or surgery | Open repair |
Primary outcome
Return of bowel function
Time frame: From completion of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days after surgery
The return of bowel function will be assessed based upon the time interval from completion of surgery until appearance of bowel sounds and passage of first flatus by the patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Repair of Perforated Duodenal Ulcer and Open Repair of Perforated Duodenal Ulcer in people with Perforated Duodenal Ulcer, run by Allied Hospital Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of bowel function (time frame: From completion of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.