Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05419440 |
| Other study ID # |
General Surgery Departement |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2020 |
| Est. completion date |
February 2, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
