Clinical trial NCT05767320: Open vs Laparoscopic Repair of Perforated Peptic Ulcer
Official title: Comparison Between Open vs Laparoscopic Repair of Perforated Peptic Ulcer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perforated Peptic Ulcer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients presenting with perforated peptic ulcer are divided into two groups ,one group undergoes open exploration and the other group undergoes laparoscopy
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time
timeFrame: baseline
measure: short term outcomes of both open and lap. Repair of perforated peptic ulcer; repair site leakage
timeFrame: baseline
measure: short term outcomes of both open and lap. Repair of perforated peptic ulcer; intra-abdominal abscess
timeFrame: baseline
measure: short term outcomes of both open and lap. Repair of perforated peptic ulcer; surgical site infection
timeFrame: baseline
measure: short term outcomes of both open and lap. Repair of perforated peptic ulcer; postoperative ileus
timeFrame: baseline
measure: short term outcomes of both open and lap. Repair of perforated peptic ulcer; hospital stay
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut university hospitals
name: Mahmoud Mohamed, Mch
role: STUDY_CHAIR
affiliation: Assiut university hospitals
name: Mostafa Sayed, Mch
role: STUDY_DIRECTOR
affiliation: Assiut university hospitals
name: Ibrahim Mostafa, Mch
role: STUDY_DIRECTOR
References:
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