An interventional study of open repair(exploration) and abdominal laparoscopy in Perforated Peptic Ulcer, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 17 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer
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.
21 studies on the registry are indexed under Peptic Ulcer Perforation; 4 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 16 interventional studies indexed under Peptic Ulcer Perforation.
Browse Peptic Ulcer Perforation studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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repair of perforated peptic ulcer by open technique (exploration)
Procedure: open repair(exploration)
repair of perforated peptic ulcer by laparoscopy
Procedure: abdominal laparoscopy
repair of defect of perforated peptic ulcer and peritoneal decontamination by exploration
repair of defect of perforated peptic ulcer and peritoneal decontamination by laparoscopy
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Ran from Sep 2023 to primary completion in Sep 2024, 12 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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