Open vs Laparoscopic Repair of Perforated Peptic Ulcer

NCT05767320 | Completed

• 1 other identifier: repair of PPU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer

Conditions

Perforated Peptic Ulcer

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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.

  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.

  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.

  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.

  baseline

Study Arms (2)

open approach for perforated pectic ulcer

ACTIVE COMPARATOR

repair of perforated peptic ulcer by open technique (exploration)

Procedure: open repair(exploration)

lap. approach for perforated peptic ulcer

ACTIVE COMPARATOR

repair of perforated peptic ulcer by laparoscopy

Procedure: abdominal laparoscopy

Interventions

open repair(exploration) PROCEDURE

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

open approach for perforated pectic ulcer

abdominal laparoscopy PROCEDURE

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

lap. approach for perforated peptic ulcer

Eligibility Criteria

• Age: 17 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (11)

• 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.

  PMID: 20033725 BACKGROUND

• Chung 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.

  PMID: 28138363 BACKGROUND

• Wang 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.

  PMID: 20009753 BACKGROUND

• Soreide 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.

  PMID: 26460663 BACKGROUND

• Moller 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.

  PMID: 21442610 BACKGROUND

• Svanes 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.

  PMID: 8053739 BACKGROUND

• Mouret 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.

  PMID: 2145052 BACKGROUND

• Arnaud 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.

  PMID: 12080252 BACKGROUND

• Lau 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.

  PMID: 15136924 BACKGROUND

• Bertleff 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.

  PMID: 19430829 BACKGROUND

• Di 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.

  PMID: 25114715 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Mahmoud Mohamed, Mch

  Assiut university hospitals

  STUDY CHAIR

• Mostafa Sayed, Mch

  Assiut university hospitals

  STUDY DIRECTOR

• Ibrahim Mostafa, Mch

  Assiut university hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: patients presenting with perforated peptic ulcer are divided into two groups ,one group undergoes open exploration and the other group undergoes laparoscopy

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: March 14, 2023
• Study Start: September 15, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

EG (1)