Perforated Peptic UlcerNCT05767320
Open vs Laparoscopic Repair of Perforated Peptic Ulcer
A study testing open repair(exploration) and abdominal laparoscopy in people with Perforated Peptic Ulcer, run by Assiut University at 1 site in Egypt.
Trial summary
comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer Read more about this study
- Who is it for?
- Ages 17 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Perforated Peptic Ulcer
- What is being tested?
- open repair(exploration) and abdominal laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients older than 16 years old and younger than 70 years old.
- Patients presenting with acute abdomen due to perforated peptic ulcer
- Patients eligible for laparoscopic surgeries
Who cannot join
- Patients younger than 16 years old and older than 70 years old
- Contraindications to laparoscopic surgeries as (Hemodynamic instability/shock, Acute intestinal obstruction with dilated bowel loops, Increased intracranial pressure, Relative contraindications, Cardiac failure, Pulmonary failure, Pregnancy/large pelvic masses, Soft tissue infection at port sites, Expected (extensive) adhesions from a previous abdominal surgery)
- Patients who absconded or left the study or died during the period of study.
- Patients with a surgical diagnosis other than perforated peptic ulcer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Open vs Laparoscopic Repair of Perforated Peptic Ulcer
comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer
Read the detailed description
With the advent of proton pump inhibitors and Helicobacter pylori (H. pylori) eradication therapy, surgical intervention for peptic ulcer disease (PUD) is limited to perforated ulcers in the emergent setting. Perforation is an acute life threatening complication of PUD and occurs in nearly 20% of cases of duodenal ulcer patients . Perforation is a common complication of PUD, with an average 2-14% of peptic ulcers resulting in perforation .While bleeding is the most frequent complication of PUD, perforation carries a higher rate of surgical intervention and is the most lethal complication, associated with a 30-days mortality risk ranging from 3-40%, with advanced age, higher American Society of Anesthesiologists (ASA) classification , elevated body mass index (BMI), and perforation diameter being non-modifiable risk factors associated with increased mortality .The only modifiable risk factor associated with mortality is time to operation, whereby a delay of more than three hours is associated with a doubling of mortality risk .In the 1990s, laparoscopic repair of PPUs was first described . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy .Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair . The choice of surgical technique, laparoscopy versus laparotomy, varies depending on the patient's preoperative clinical status, surgeon expertise/preference, and location of defect, with the goal of short operative time. It has been widely reported that open abdominal surgery increases postoperative pain and is associated with higher morbidity (ventral incisional hernia rate, surgical site infection, postoperative respiratory compromise, delayed recovery times, and dehiscence) when compared to laparoscopic surgery . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy. Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair .Despite these favorable outcomes, laparoscopic repair is less commonly used, owning to longer operative times in less experienced centers, higher incidence of reoperations owning to leakage at the repair site, and higher incidence of intraabdominal fluid collections secondary to inadequate lavage and the requirement of extensive surgical skill . Additionally, others point to laparotomy as the better treatment, especially for repairing ulcers larger than 9 mm.
- Conditions
- Perforated Peptic Ulcer
- Being tested
- open repair(exploration), abdominal laparoscopy
- Medical subject headings
- Peptic Ulcer Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open repair(exploration)Procedure or surgery
repair of defect of perforated peptic ulcer and peritoneal decontamination by exploration
abdominal laparoscopyProcedure or surgery
repair of defect of perforated peptic ulcer and peritoneal decontamination by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| open approach for perforated pectic ulcer | Active comparator | repair of perforated peptic ulcer by open technique (exploration) Receives: Procedure: open repair(exploration) |
| lap. approach for perforated peptic ulcer | Active comparator | repair of perforated peptic ulcer by laparoscopy Receives: Procedure: abdominal laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time
comparison of operative time of both laparoscopic and open surgical repair of perforated peptic ulcer
Measured: baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; repair site leakage
comparison of repair site leakage between both lap. and open surgical repair of perforated peptic ulcer by follow up through drains inspection.
Measured: baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; intra-abdominal abscess
comparison of intra-abdominal abscess formation between both lap. and open surgical repair of perforated peptic ulcer by follow up through abdominal ultrasonography.
Measured: baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; surgical site infection
comparison of surgical site infection between both lap. and open surgical repair of perforated peptic ulcer through daily dressing and wound inspection for signs of inflammation.
Measured: baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; postoperative ileus
comparison of postoperative ileus between both lap. and open surgical repair of perforated peptic ulcer by follow up of bowel movements.
Measured: baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; hospital stay
comparison of duration of patient's hospital stay between both lap. and open surgical repair of perforated peptic ulcer.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start15 Sep 2023
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Perforated Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Model description
- patients presenting with perforated peptic ulcer are divided into two groups ,one group undergoes open exploration and the other group undergoes laparoscopy
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Magdy Dawood, Assiut University
- Investigators
- Mahmoud Mohamed, Mch, Study chair, Assiut university hospitalsMostafa Sayed, Mch, Study director, Assiut university hospitalsIbrahim Mostafa, Mch, Study director, Assiut university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767320
- Sponsor's protocol ID
- repair of PPU
- Status last verified
- Jul 2025
- First submitted
- 24 Dec 2022
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertleff MJ, Lange JF. Laparoscopic correction of perforated peptic ulcer: first choice? A review of literature. Surg Endosc. 2010 Jun;24(6):1231-9. doi: 10.1007/s00464-009-0765-z. Epub 2009 Dec 24.
PubMed 20033725Chung KT, Shelat VG. Perforated peptic ulcer - an update. World J Gastrointest Surg. 2017 Jan 27;9(1):1-12. doi: 10.4240/wjgs.v9.i1.1.
PubMed 28138363Wang YR, Richter JE, Dempsey DT. Trends and outcomes of hospitalizations for peptic ulcer disease in the United States, 1993 to 2006. Ann Surg. 2010 Jan;251(1):51-8. doi: 10.1097/SLA.0b013e3181b975b8.
PubMed 20009753Soreide K, Thorsen K, Harrison EM, Bingener J, Moller MH, Ohene-Yeboah M, Soreide JA. Perforated peptic ulcer. Lancet. 2015 Sep 26;386(10000):1288-1298. doi: 10.1016/S0140-6736(15)00276-7.
PubMed 26460663Moller MH, Adamsen S, Thomsen RW, Moller AM; Peptic Ulcer Perforation (PULP) trial group. Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation. Br J Surg. 2011 Jun;98(6):802-10. doi: 10.1002/bjs.7429. Epub 2011 Mar 25.
PubMed 21442610Svanes C, Lie RT, Svanes K, Lie SA, Soreide O. Adverse effects of delayed treatment for perforated peptic ulcer. Ann Surg. 1994 Aug;220(2):168-75. doi: 10.1097/00000658-199408000-00008.
PubMed 8053739Mouret P, Francois Y, Vignal J, Barth X, Lombard-Platet R. Laparoscopic treatment of perforated peptic ulcer. Br J Surg. 1990 Sep;77(9):1006. doi: 10.1002/bjs.1800770916. No abstract available.
PubMed 2145052Arnaud JP, Tuech JJ, Bergamaschi R, Pessaux P, Regenet N. Laparoscopic suture closure of perforated duodenal peptic ulcer. Surg Laparosc Endosc Percutan Tech. 2002 Jun;12(3):145-7. doi: 10.1097/00129689-200206000-00001.
PubMed 12080252Lau H. Laparoscopic repair of perforated peptic ulcer: a meta-analysis. Surg Endosc. 2004 Jul;18(7):1013-21. doi: 10.1007/s00464-003-8266-y. Epub 2004 May 12.
PubMed 15136924Bertleff MJ, Halm JA, Bemelman WA, van der Ham AC, van der Harst E, Oei HI, Smulders JF, Steyerberg EW, Lange JF. Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial. World J Surg. 2009 Jul;33(7):1368-73. doi: 10.1007/s00268-009-0054-y.
PubMed 19430829Di Saverio S, Bassi M, Smerieri N, Masetti M, Ferrara F, Fabbri C, Ansaloni L, Ghersi S, Serenari M, Coccolini F, Naidoo N, Sartelli M, Tugnoli G, Catena F, Cennamo V, Jovine E. Diagnosis and treatment of perforated or bleeding peptic ulcers: 2013 WSES position paper. World J Emerg Surg. 2014 Aug 3;9:45. doi: 10.1186/1749-7922-9-45. eCollection 2014. No abstract available.
PubMed 25114715
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Open vs Laparoscopic Repair of Perforated Peptic Ulcer
- ClinicalTrials.gov ID
- NCT05767320
- Acronym / sponsor ID
- repair of PPU
- Conditions
- Perforated Peptic Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 14 Mar 2023 (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.
comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer
Detailed description
With the advent of proton pump inhibitors and Helicobacter pylori (H. pylori) eradication therapy, surgical intervention for peptic ulcer disease (PUD) is limited to perforated ulcers in the emergent setting. Perforation is an acute life threatening complication of PUD and occurs in nearly 20% of cases of duodenal ulcer patients . Perforation is a common complication of PUD, with an average 2-14% of peptic ulcers resulting in perforation .While bleeding is the most frequent complication of PUD, perforation carries a higher rate of surgical intervention and is the most lethal complication, associated with a 30-days mortality risk ranging from 3-40%, with advanced age, higher American Society of Anesthesiologists (ASA) classification , elevated body mass index (BMI), and perforation diameter being non-modifiable risk factors associated with increased mortality .The only modifiable risk factor associated with mortality is time to operation, whereby a delay of more than three hours is associated with a doubling of mortality risk .In the 1990s, laparoscopic repair of PPUs was first described . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy .Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair . The choice of surgical technique, laparoscopy versus laparotomy, varies depending on the patient's preoperative clinical status, surgeon expertise/preference, and location of defect, with the goal of short operative time. It has been widely reported that open abdominal surgery increases postoperative pain and is associated with higher morbidity (ventral incisional hernia rate, surgical site infection, postoperative respiratory compromise, delayed recovery times, and dehiscence) when compared to laparoscopic surgery . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy. Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair .Despite these favorable outcomes, laparoscopic repair is less commonly used, owning to longer operative times in less experienced centers, higher incidence of reoperations owning to leakage at the repair site, and higher incidence of intraabdominal fluid collections secondary to inadequate lavage and the requirement of extensive surgical skill . Additionally, others point to laparotomy as the better treatment, especially for repairing ulcers larger than 9 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients presenting with perforated peptic ulcer are divided into two groups ,one group undergoes open exploration and the other group undergoes laparoscopy
| Arm | Type | Receives |
|---|---|---|
| open approach for perforated pectic ulcer | Active comparator | Procedure: open repair(exploration)repair of perforated peptic ulcer by open technique (exploration) |
| lap. approach for perforated peptic ulcer | Active comparator | Procedure: abdominal laparoscopyrepair of perforated peptic ulcer by laparoscopy |
Who may qualify
- Ages
- 17 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 16 years old and younger than 70 years old.
- Patients presenting with acute abdomen due to perforated peptic ulcer
- Patients eligible for laparoscopic surgeries
Key exclusion criteria (4 listed)
- Patients younger than 16 years old and older than 70 years old
- Contraindications to laparoscopic surgeries as (Hemodynamic instability/shock, Acute intestinal obstruction with dilated bowel loops, Increased intracranial pressure, Relative contraindications, Cardiac failure, Pulmonary failure, Pregnancy/large pelvic masses, Soft tissue infection at port sites, Expected (extensive) adhesions from a previous abdominal surgery)
- Patients who absconded or left the study or died during the period of study.
- Patients with a surgical diagnosis other than perforated peptic ulcer
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 |
|---|---|---|
| open repair(exploration)repair of defect of perforated peptic ulcer and peritoneal decontamination by exploration | Procedure or surgery | open approach for perforated pectic ulcer |
| abdominal laparoscopyrepair of defect of perforated peptic ulcer and peritoneal decontamination by laparoscopy | Procedure or surgery | lap. approach for perforated peptic ulcer |
Primary outcome
short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time
Time frame: baseline
comparison of operative time of both laparoscopic and open surgical repair of perforated peptic ulcer
short term outcomes of both open and lap. Repair of perforated peptic ulcer; repair site leakage
Time frame: baseline
comparison of repair site leakage between both lap. and open surgical repair of perforated peptic ulcer by follow up through drains inspection.
short term outcomes of both open and lap. Repair of perforated peptic ulcer; intra-abdominal abscess
Time frame: baseline
comparison of intra-abdominal abscess formation between both lap. and open surgical repair of perforated peptic ulcer by follow up through abdominal ultrasonography.
short term outcomes of both open and lap. Repair of perforated peptic ulcer; surgical site infection
Time frame: baseline
comparison of surgical site infection between both lap. and open surgical repair of perforated peptic ulcer through daily dressing and wound inspection for signs of inflammation.
short term outcomes of both open and lap. Repair of perforated peptic ulcer; postoperative ileus
Time frame: baseline
comparison of postoperative ileus between both lap. and open surgical repair of perforated peptic ulcer by follow up of bowel movements.
short term outcomes of both open and lap. Repair of perforated peptic ulcer; hospital stay
Time frame: baseline
comparison of duration of patient's hospital stay between both lap. and open surgical repair of perforated peptic ulcer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 20033725Bertleff MJ, Lange JF. Laparoscopic correction of perforated peptic ulcer: first choice? A review of literature. Surg Endosc. 2010 Jun;24(6):1231-9. doi: 10.1007/s00464-009-0765-z. Epub 2009 Dec 24.
- Background: PubMed 28138363Chung KT, Shelat VG. Perforated peptic ulcer - an update. World J Gastrointest Surg. 2017 Jan 27;9(1):1-12. doi: 10.4240/wjgs.v9.i1.1.
- Background: PubMed 20009753Wang YR, Richter JE, Dempsey DT. Trends and outcomes of hospitalizations for peptic ulcer disease in the United States, 1993 to 2006. Ann Surg. 2010 Jan;251(1):51-8. doi: 10.1097/SLA.0b013e3181b975b8.
- Background: PubMed 26460663Soreide K, Thorsen K, Harrison EM, Bingener J, Moller MH, Ohene-Yeboah M, Soreide JA. Perforated peptic ulcer. Lancet. 2015 Sep 26;386(10000):1288-1298. doi: 10.1016/S0140-6736(15)00276-7.
- Background: PubMed 21442610Moller MH, Adamsen S, Thomsen RW, Moller AM; Peptic Ulcer Perforation (PULP) trial group. Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation. Br J Surg. 2011 Jun;98(6):802-10. doi: 10.1002/bjs.7429. Epub 2011 Mar 25.
- Background: PubMed 8053739Svanes C, Lie RT, Svanes K, Lie SA, Soreide O. Adverse effects of delayed treatment for perforated peptic ulcer. Ann Surg. 1994 Aug;220(2):168-75. doi: 10.1097/00000658-199408000-00008.
- Background: PubMed 2145052Mouret P, Francois Y, Vignal J, Barth X, Lombard-Platet R. Laparoscopic treatment of perforated peptic ulcer. Br J Surg. 1990 Sep;77(9):1006. doi: 10.1002/bjs.1800770916. No abstract available.
- Background: PubMed 12080252Arnaud JP, Tuech JJ, Bergamaschi R, Pessaux P, Regenet N. Laparoscopic suture closure of perforated duodenal peptic ulcer. Surg Laparosc Endosc Percutan Tech. 2002 Jun;12(3):145-7. doi: 10.1097/00129689-200206000-00001.
- Background: PubMed 15136924Lau H. Laparoscopic repair of perforated peptic ulcer: a meta-analysis. Surg Endosc. 2004 Jul;18(7):1013-21. doi: 10.1007/s00464-003-8266-y. Epub 2004 May 12.
- Background: PubMed 19430829Bertleff MJ, Halm JA, Bemelman WA, van der Ham AC, van der Harst E, Oei HI, Smulders JF, Steyerberg EW, Lange JF. Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial. World J Surg. 2009 Jul;33(7):1368-73. doi: 10.1007/s00268-009-0054-y.
- Background: PubMed 25114715Di Saverio S, Bassi M, Smerieri N, Masetti M, Ferrara F, Fabbri C, Ansaloni L, Ghersi S, Serenari M, Coccolini F, Naidoo N, Sartelli M, Tugnoli G, Catena F, Cennamo V, Jovine E. Diagnosis and treatment of perforated or bleeding peptic ulcers: 2013 WSES position paper. World J Emerg Surg. 2014 Aug 3;9:45. doi: 10.1186/1749-7922-9-45. eCollection 2014. No abstract available.
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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. This study is not recruiting at the moment.
Mahmoud Mohamed, Mch study chair
Assiut university hospitals
Mostafa Sayed, Mch study director
Assiut university hospitals
Ibrahim Mostafa, Mch study director
Assiut university hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open repair(exploration) and abdominal laparoscopy in people with Perforated Peptic Ulcer, run by Assiut University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 8 Jul 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05767320, which also lists 11 linked publications.
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 8 Jul 2025.