Open vs Laparoscopic Repair of Perforated Peptic Ulcer

NCT ID: NCT05767320

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-09-15

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.

Conditions

Perforated Peptic Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

open approach for perforated pectic ulcer

repair of perforated peptic ulcer by open technique (exploration)

Group Type: ACTIVE_COMPARATOR

open repair(exploration)

Intervention Type: PROCEDURE

repair of defect of perforated peptic ulcer and peritoneal decontamination by exploration

lap. approach for perforated peptic ulcer

repair of perforated peptic ulcer by laparoscopy

Group Type: ACTIVE_COMPARATOR

abdominal laparoscopy

Intervention Type: PROCEDURE

repair of defect of perforated peptic ulcer and peritoneal decontamination by laparoscopy

Interventions

open repair(exploration)

repair of defect of perforated peptic ulcer and peritoneal decontamination by exploration

Intervention Type: PROCEDURE

abdominal laparoscopy

repair of defect of perforated peptic ulcer and peritoneal decontamination by laparoscopy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mina Magdy Dawood

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Mohamed, Mch

Role: STUDY_CHAIR

Assiut university hospitals

Mostafa Sayed, Mch

Role: STUDY_DIRECTOR

Assiut university hospitals

Ibrahim Mostafa, Mch

Role: STUDY_DIRECTOR

Assiut university hospitals

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

repair of PPU

Identifier Type: -

Identifier Source: org_study_id