search
Back to results

Open vs Laparoscopic Repair of Perforated Peptic Ulcer

Primary Purpose

Perforated Peptic Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
open repair(exploration)
abdominal laparoscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforated Peptic Ulcer

Eligibility Criteria

17 Years - 69 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    open approach for perforated pectic ulcer

    lap. approach for perforated peptic ulcer

    Arm Description

    repair of perforated peptic ulcer by open technique (exploration)

    repair of perforated peptic ulcer by laparoscopy

    Outcomes

    Primary Outcome Measures

    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
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 24, 2022
    Last Updated
    March 2, 2023
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05767320
    Brief Title
    Open vs Laparoscopic Repair of Perforated Peptic Ulcer
    Official Title
    Comparison Between Open vs Laparoscopic Repair of Perforated Peptic Ulcer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2023 (Anticipated)
    Primary Completion Date
    January 15, 2025 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perforated Peptic Ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    open approach for perforated pectic ulcer
    Arm Type
    Active Comparator
    Arm Description
    repair of perforated peptic ulcer by open technique (exploration)
    Arm Title
    lap. approach for perforated peptic ulcer
    Arm Type
    Active Comparator
    Arm Description
    repair of perforated peptic ulcer by laparoscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    open repair(exploration)
    Intervention Description
    repair of defect of perforated peptic ulcer and peritoneal decontamination by exploration
    Intervention Type
    Procedure
    Intervention Name(s)
    abdominal laparoscopy
    Intervention Description
    repair of defect of perforated peptic ulcer and peritoneal decontamination by laparoscopy
    Primary Outcome Measure Information:
    Title
    short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time
    Description
    comparison of operative time of both laparoscopic and open surgical repair of perforated peptic ulcer
    Time Frame
    baseline
    Title
    short term outcomes of both open and lap. Repair of perforated peptic ulcer; repair site leakage
    Description
    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
    Title
    short term outcomes of both open and lap. Repair of perforated peptic ulcer; intra-abdominal abscess
    Description
    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
    Title
    short term outcomes of both open and lap. Repair of perforated peptic ulcer; surgical site infection
    Description
    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
    Title
    short term outcomes of both open and lap. Repair of perforated peptic ulcer; postoperative ileus
    Description
    comparison of postoperative ileus between both lap. and open surgical repair of perforated peptic ulcer by follow up of bowel movements.
    Time Frame
    baseline
    Title
    short term outcomes of both open and lap. Repair of perforated peptic ulcer; hospital stay
    Description
    comparison of duration of patient's hospital stay between both lap. and open surgical repair of perforated peptic ulcer.
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mina Magdy, MBBS
    Phone
    01559997080
    Email
    mena_titan@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mahmoud Mohamed, Mch
    Organizational Affiliation
    Assiut university hospitals
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mostafa Sayed, Mch
    Organizational Affiliation
    Assiut university hospitals
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ibrahim Mostafa, Mch
    Organizational Affiliation
    Assiut university hospitals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20033725
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28138363
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20009753
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26460663
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21442610
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8053739
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2145052
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12080252
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15136924
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19430829
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25114715
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Open vs Laparoscopic Repair of Perforated Peptic Ulcer

    We'll reach out to this number within 24 hrs