Laparoscopic Drainage Versus Interventional Radiology In Management Of Appendicular Abscess :

NCT05419440 | Completed

• 1 other identifier: General Surgery Departement
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled clinical trial included all patients who developed the manifestations of appendicular abscess and referred to the Zagazig University Hospital Emergency Department between January 2020 and February 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 55342/24.1.2020). The sample size was 172 patients divided into two equal group group (1) laparoscopic group involved 86 patients \& group (2) interventional radiology group involved 86 patients.

Conditions

Acute Abdomen

Keywords

appendicular abscess , laparoscopy

Outcome Measures

Primary Outcomes (1)

• incidence of complications after laparoscopic drainage of appendicular abscess

  incidence of complications after laparoscopic drainage of appendicular abscess

  within one week after laparoscopic drainage of the appendicular abscess

Secondary Outcomes (1)

• incidence of mortality after laparoscopic drainage of appendicular abscess

  within one month after laparoscopic drainage of appendicular abscess

Study Arms (2)

laparoscopic drainage of appendicular abscess

ACTIVE COMPARATOR

laparoscopic drainage of appendicular abscess laparoscopy drainage of pus ,excision of appendix and putting a drain

Procedure: laparoscopic drainage of appendicular abscess

interventional radiology for management of appendicular abscess

NO INTERVENTION

insertion of a drain or pig tail under sonar or ct guided

Interventions

laparoscopic drainage of appendicular abscess PROCEDURE

access to caecum and remove any adhesions with surrounding by sharp \& blunt dissection , then access to appendicular abscess by sharp and blunt dissection after complete separation of the appendix from surrounding \& complete drainage of pus \& removal of all necrotic tissue , removal of the remnant appendix , in cases with healthy base of appendix ,we closed the stump with endo-loop , in case with unhealthy base , we closed the stump by suturing by ethibond 2/0 in two layers in case with little edema \& inflammation of caecum ( sutures not cut through ) , in cases with marked edema and inflammation of caecum , we close the site of base by omental patch fixed by taking full thickness sutures in wall of caecum and pass through omental patch , we examine any leak by pressing on caecum and observe any fecal matter comes \& air leak test , in all cases we put large drain at pelvis

laparoscopic drainage of appendicular abscess

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥16- ≤60 years-old with appendicular abscess
• with early sepsis.
• no septic shock.
• ASA I \& II.
• no other pathology .
• candidate for laparoscopy .

You may not qualify if:

• \<16- \>60 years-old .
• septic shock.
• appendicular mass.
• \*, ASA III .
• previous abdominal operations.
• immune compromised patients .
• patients with immune suppressive therapy.
• pregnant patients not
• candidate for laparoscopy

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharquia, 1185, Egypt

Location

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Said Mohamed Negm, MD

  Zagazig University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Model Details: This prospective randomized controlled clinical trial included all patients who developed the manifestations of appendicular abscess and referred to the Zagazig University Hospital Emergency Department between January 2020 and February 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 55342/24.1.2020), The sample size was 172 patients divided into two equal group group (1) laparoscopic group involved 86 patients \& group (2) interventional radiology group involved 86 patients.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 15, 2022
• Study Start: January 10, 2020
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)