Clinical trial NCT05419440: Laparoscopic Drainage Versus Interventional Radiology In Management Of Appendicular Abscess :
Official title: Laparoscopic Drainage Versus Interventional Radiology In Management Of Appendicular Abscess : A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Abdomen
Keywords: appendicular abscess , laparoscopy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-06-15
Enrollment: 172
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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), and was retrospectively submitted in clinicaltrials.gov in September 2021 (NCT05051683). The study was performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. Written informed consent was obtained from all participants after explaining to them all the study procedures with its benefits and hazards. Patients ≥16- ≤60 years-old, with appendicular abscess , with early sepsis , no septic shock , ASA I \& II , no other pathology and candidate for laparoscopy were deemed eligible for randomization. We excluded patients who were \<16- \>60 years-old, septic shock, appendicular mass, ASA III , previous abdominal operations, immune compromised patients , patients with immune suppressive therapy, pregnant patients and not candidate for laparoscopy.

Involved patients were simply randomized at a 1:1 ratio to "laparoscopic Group (LG)" or "Interventional Radiology Group (IG)" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the procedure.

The sample size was calculated by using open Epi program depending on the following data ; confidence interval 95%, power of the test 80%, ratio of unexposed/exposed 1, percent of patients with complications after management of appendicular abscess by interventional radiology 15 %, and those managed by laparoscopy 2 % , odds ratio 8.7 , and risk ratio 7.5, So the calculated sample size equal 172 patients divided into two equal group.

Primary and secondary outcomes were fecal fistula , recurrent collection and quality of life in each group after the procedures during the 3-months follow-up period, respectively.

Diagnosis After full history taking ( throbbing pain at right iliac fossa several days ago ) and complete physical examination ( fluctuant high grade fever especially at evening , severe pain \& tenderness at right iliac fossa , toxic manifestations), appendicular abscess was clinically suspected and then confirmed by laboratory investigations (complete blood picture (WBC count more than 16000), liver and kidney functions, coagulation profile), radiological imaging (abdominal US or CT abdomen with oral and I.V contrast confirms appendicular abscess) , in laparoscopic group we exclude patients with other pathology after laparoscopic exploration However, the radiology finding was consistent with appendicular abscess.

Intervention For laparoscopic group ( included 86 patients ) , the patients were subjected to the following steps after the diagnosis has been confirmed as appendicular abscess. The patients were taken rapidly to operative theater , general anesthesia was given , patients were put in supine position , sterilization of the abdomen from subcostal margin to pubic bone was done , ports insertion was done , one 10 mm port supra-umbilical , one 5mm port at left iliac fossa , one 5mm port at right iliac fossa , insertion of the 10 mm port was done first by open method or versus needle , insufflation of co2 up to 14 mm.hg was done after 10 mm port insertion , exploration of the abdomen first by 10 mm telescope , to exclude other pathology and confirm the diagnosis ( we exclude patients with other pathology after laparoscopic exploration ) , then insertion of other two ports under vision , removal of any adhesions first , irrigation \& suction whole the abdomen first with warm saline 0.9% , access to caecum by tilting the table head down and to left to pull all intestine away from caecum , access to caecum and remove any adhesions with surrounding by sharp \& blunt dissection , then access to appendicular abscess by sharp and blunt dissection , drain all the pus by suction , irrigation with warm saline , 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 made irrigation \& suction with 2000cc warm saline and put large drain at pelvis to be removed later according to its discharge , deflation of the abdomen and close the port sites. Then patients were kept in hospital under observation till drain removal.

For interventional radiology group ( included 86 patients ) , patients were subjected for drain insertion or pig catheter insertion at right iliac fossa under a complete sterilized filed by radiologist , then daily wash from drain or pig catheter by gentamycin \& metronidazole till drain discharge comes clear fluid , then drain removed according the amount of discharge and doing us confirm there is no residual.

Statistical analysis Analysis of data was performed using SPSS (Statistical Package of Social Services) version 22. Quantitative variables were described as mean (±SD, standard deviation) and median (range) according to Shapiro test of normality. Qualitative variables were described as a number and a percent. Chi-square test was used to compare qualitative variables between the 2 groups. Fisher exact test was used when one expected cell or more are less than 5. Unpaired t-test was used to compare quantitative variables, in parametric data (SD \< 30% of the mean). Mann Whitney test was used instead of unpaired t-test in non-parametric data (SD \> 30% of the mean). The results were considered statistically significant when the significant probability was less than 0.05 (P \< 0.05). P-value \< 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \<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

Primary outcomes:
measure: incidence of complications after laparoscopic drainage of appendicular abscess
timeFrame: within one week after laparoscopic drainage of the appendicular abscess
Secondary outcomes:
measure: incidence of mortality after laparoscopic drainage of appendicular abscess
timeFrame: within one month after laparoscopic drainage of appendicular abscess
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Sharquia
Study officials:
affiliation: Zagazig University Hospitals
name: Said Mohamed Negm, MD
role: PRINCIPAL_INVESTIGATOR
References: