Laparoscopic Drainage Versus Interventional Radiology for Management Of Appendicular Abscess : A Randomized Controlled Trial

doi:10.21203/rs.3.rs-1975645/v1

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Laparoscopic Drainage Versus Interventional Radiology for Management Of Appendicular Abscess : A Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-1975645/v1

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published 22 Mar, 2024

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Background:

Laparoscopic drainage of appendicular abscess has become a novel technique due to its advantages over interventional radiology like complete exploration of the abdomen, exclusion of other pathologies, excision of the appendix at same session, better cosmesis, decrease incidence of wound infection & incisional hernia, better visualization of surgical field, fine handling of edematous tissue and drainage of multiple collections.

Methods:

Results:

“Group 1 (laparoscopic drainage group) included 86 patients: 55.8% were males, with a mean age of 41.2 (± 12.2) years-old, while in group 2 (interventional radiology group) included 86 patients: 51.2% were males, with a mean age of 36.8 (± 10.9) years-old. The reported complications were bowel injury, fecal fistula, recurrence, pelvic collection and mortality with incidence rates of occurrence 1(1.2%), 3 (3.5%), 0 (0%), 0 (0%), 0(0%) respectively in group (1) while in group(2) were 5(5.8%), 0(0%), 3(3.5%), 8(9.3%), 1(1.2%) respectively. Regarding quality of life in both groups were excellent, good, poor with incidence rates of 48(55.8%), 38(44.2%), 0(0%) respectively in group (1), and 12(14%), 59(68.6%), 15(17.4%) respectively in group(2).

Conclusion:

Laparoscopic management of appendicular abscess can be safely applied in a good experienced hand with no mortality & morbidity, without the need for interval appendectomy.

appendicular abscess

interventional radiology

surgical emergency

laparoscopy

Abscess formation is one of the most serious complications of acute perforated appendicitis with an incidence of 2-10%⁽¹⁾. In cases of acute appendicitis, the gold standard management is appendectomy, while in the setting of appendicular abscess, the standard treatment is still controversial⁽²⁾ . The surgical management of appendicular abscess may be complicated with bowel injury, wound infection and paralytic ileus⁽³⁾. With the recent advances in interventional radiology, non-operative management of appendicular abscess becomes the trend⁽⁴⁾. Appendicular abscess can be managed by CT-guided drainage trans-abdominal, trans-rectal or trans-vaginal then patients may be later managed with interval appendectomy⁽⁵⁾. Moreover, laparoscopic concurrent appendicular abscess drainage with appendectomy has been established in many centers with the advantages of shorter hospital stay, rapid recovery, better cosmesis and better access and good visualization of operative field⁽⁶⁾ . In the setting appendicular abscess, advantages of laparoscopy over interventional radiology are complete exploration of the abdomen , exclusion of other pathologies and excision of the appendix at same session, while patients, managed with interventional radiology may be still in need for interval appendectomy⁽⁷⁾ . In this study, we compare laparoscopic versus interventional management of appendicular abscess regarding advantages, efficacy & safety.

Objectives:

To compare laparoscopic versus interventional management of appendicular abscess regarding advantages, efficacy &safety.

Patients

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 2020and February2022.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 15/6/2022 (ClinicalTrials.gov ID: NCT05419440). 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- >60years-old, septic shock, appendicular mass, ASA > III, previous abdominal operations, intraoperative presence of other pathologies, immune compromised patients, patients with immune suppressive therapy, pregnant patients and not candidate for laparoscopy.

The included 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 was 172 patients divided into two equal group.

Primary and secondary outcomes were postoperative incidence of fecal fistula and, recurrent collection ,and quality of life in each group 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(WBC count more than 16000), liver and kidney functions, coagulation profile, radiological imaging (abdominal US or CT with oral and I.V contrast confirmed the appendicular abscess).There are Criteria for preoperative diagnosis of appendicular abscess and used in diagnosis in cases with negative CT & US findings constant throbbing pain at right iliac fossa, high grade hectic fever, mass at right iliac fossa felt per abdomen, prolonged diarrhea with nausea & vomiting, increased micturition and tenesmus, high WBC count more than 16000, patients not improving by medications⁽⁸⁾.

Intervention

Laparoscopic group patients were subjected to the following steps after the diagnosis has been confirmed as appendicular abscess. Under general anesthesia, in supine position, ports were inserted, one 10 mm port supra-umbilical (open method or Veress needle), one 5mm port at left iliac fossa, one 5mm port at right iliac fossa. First step was exploration of the abdomen to exclude other pathologies and confirm the diagnosis (we exclude patients with other pathologies after laparoscopic exploration). First step, irrigation & suction of the whole the abdominal cavity with warm saline 0.9%, irrigation with warm saline help in separating the adhesions between the bowels⁽⁹⁾, better visualization of the tissue, Second step was removal of any adhesions. We then gained access to the caecum by tilting the table head down and to left to keep all the small intestine away from caecum, removal of any adhesions with the surroundings by sharp & blunt dissection to gain access to appendicular abscess, drain all the pus by suction and 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 was performed., In cases with healthy base of appendix,we closed the stump with endo-loop. In cases 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) but if there was marked edema and inflammation of caecum and due to severe inflammation and adhesions in the right iliac fistula we closed the site of base by omental patch that was fixed in place by full thickness sutures in wall of caecum and pass through omental patch.We use the omental patch in our center in attempt to seal perforation and actually, it may help to prevent leakage or fistula and it is impossible to cause fistula or leak as we used it to cover the site of base of appendix and fixed it in healthy tissue like mechanism of sealed perforation by omentum in perforated peptic ulcer. If fistula occurred it was not related to omental patch fixtion, even if fistula was occurred, it is low output fistula and close spontaneous within a week provided drainage^(10)(11).

We examined any leak by pressing on caecum and observe any fecal matter leak & air leak test., Finally, irrigation &suction with 2000cc warm saline was performed and a large caliber drain was left in the pelvis to be removed later according to its output. Then patients stayed in hospital under observation till drain removal.

For interventional radiology group, patients were subjected for tube drain or pigtail catheter insertion at right iliac fossa by an interventional radiologist, then daily wash from drain or pigtail catheter using gentamycin & metronidazole till drain output showed clear fluid, therefore the drain was removed according the amount of discharge and US confirmed that there is no residual according to interventional radiologist advice ⁽¹²⁾.In the failed cases of PC, there was no clear ultrasonic window to the right iliac fossa. we routinely perform interval appendectomy.

Statistical analysis:

Analysis of data was done by IBM computer using SPSS (statistical program for social science version 23) as follows: Description of quantitative variables as Mean, SD, median and IQR. Shapiro test of normality used to check the data distribution. Description of qualitative variables as number and percentage. Chi-square test was used to compare qualitative variables between groups. Fisher exact test was used when one expected cell or more are less than 5.Independent T test was used to compare quantitative between two groups .Mann Whitney test was used instead of unpaired t-test in non-parametric data (SD > 30%mean). Multiple linear regression models conducted to find predictors to hospital stay. Multiple Binary logistic regressions conducted to find predictors to quality of life. P value is considered significant when it becomes < 0.05 ⁽¹³⁾.

This study included 200 patients, 28 patients of them did not met inclusion criteria ( 10 patients had appendicular mass not abscess after laparoscopic exploration, 4 patients were pregnant, 4 patients with intestinal obstruction due to ileus not candidate for laparoscopy or interventional radiology due to distended bowel with risk of injury, 6 patients were diabetic, 4 patient were on immunosuppressive medications ). So the final number of the patients included in our study was 172 patients divided into equal groups (86 patients in the Laparoscopic group and 86 patients in the interventional radiology group). In our study there was no significant difference regarding sex in both groups as shown in table (1).But there was significant difference regarding age in both group as shown in table (3).

Patients in Laparoscopic groups presented with nausea, vomiting, fever, pain at right iliac fossa, tenderness at right iliac fossa and a mass felt at right iliac fossa with incidence of 43(50%), 39(45.3%), 38(44.2%), 19(22.1%), 22(25.6%), 22(25.6%) and, 18(20.9%) respectively. In Interventional radiology group, patients presented with nausea, vomiting, fever, pain at right iliac fossa, tenderness at right iliac fossa and a mass felt at right iliac fossa with incidence of 36(41.9%), 35(40.7%), 42(48.8%), 24(27.9%), 24(27.9%), 14(16.3%), and 15(17.4%), respectively.as in table (1).

US & CT findings of suggestive of appendicular abscess were with no clinical significant in both groups as shown in table (1).

Size of appendicular abscess ranged from small, moderate and large size in both groups., small size abscess (1-2cm) occurred in 22 (25.6%) patients, moderate size (2-4cm) according to radiological classification ⁽¹⁴⁾ occurred in 30 (34.9%) patients, large size (4-7cm) occurred in 34(39.5%) patients this in group (1). Small size abscess (1-2cm) occurred in 18(20.9%) patients, moderate size occurred in 34(39.5%) patients, large size 34(39.5%), in group (2) as in table (1).

The complications in both groups were bowel injury, fecal fistula, recurrence, pelvic collection and mortality with incidence of occurrence 1(1.2%), 3 (3.5%), 0 (0%), 0 (0%), 0(0%) respectively in group (1) while in group(2) were 5(5.8%), 0(0%), 3(3.5%), 8(9.3%), 1(1.2%) respectively as in table (2).

The median length of hospital stay in group (1) was 6 (range: 5–7) days with, while in group (2), it was 15 (range: 13–17) days. No patients needed conversion to open surgery or needed further operation to remove appendix in group (1), while in group (2), there were 13 (15.1%) patients needed a completion surgery (either open in 3 patients or laparoscopic in 10 patients), and all patients needed to be subjected for further surgery to remove appendix as in table (2) .

In multiple backward linear regression models, the predictors of prolonged postoperative hospital stay group were being in the intervention radiology group (adjusted B coefficients − 0.873) and being female.

Regarding Quality of life in both groups was excellent, good, poor with incidence rate of 48(55.8%), 38(44.2%), 0(0%) respectively in group (1), and 12(14%), 59(68.6%), 15(17.4%) respectively in group(2) in table (4).

In multiple backward linear regression models, the significant predictors of excellent quality of life were patients who underwent perform laparoscopic intervention (OR 7.897).

Although Laparoscopic drainage of appendicular abscess has many advantages over the interventional radiology, it has a risk of bowel resection (ileocolic resection) of early surgery for appendicular abscess .it is extremely rare to occur if laparoscopic surgery was done by good experienced hand Laparoscopic drainage of appendicular abscess in a good experienced hand has proven its efficacy & safety without increased incidence of mortality & morbidity ⁽¹⁵⁾.

In this study, the complications that occurred, in laparoscopic group included bowel injury in one patient during sharp & blunt dissection of adhesions between the edematous bowel loops by laparoscopic instruments, fecal fistula occurred in three patients due to slipped ligature at the base of either non-healthy or friable appendix. The fecal fistulae were managed successfully using conservative treatment. All the fistulae closed within one week without any mortality or morbidity. While in interventional radiology group the complications included bowel injury occurred in five patients, 4 of them with small size abscess, one with moderate size. The bowel injury may have occurred due to lack of experience of interventional radiologist and improper visualization of bowel by US or CT. Recurrence of appendicular abscess occurred in three patient in interventional radiology group due to inadequate drainage and multi-loculated abscess. These 3 patients were successfully managed using laparoscopy. Pelvic collection occurred in eight patients in interventional radiology group and were successfully managed using laparoscopy, as well. Mortality occurred in one patient in interventional radiology group due to bowel injury that resulted in sepsis, septic shock with multi-organ failure and death.15,1% of PC drainage patients needed surgery either laparoscopic (10 patients) or open (3 patients as there were not candidate for laparoscopy as they developed ileus) surgery, they needed surgery as there was no improvement in their conditions regarding fever, abdominal pain, vomiting, no decrease in leucocyte count, patients were still toxic, surgery was done immediately .failure of interventional radiology drainage does not mean, radiologists were not experienced, as there are many causes of failure like, multiloculated abscess, cases associated with pelvic abscess also, thick pus and can't be come out through the drain, tip of drain was blocked by necrotic tissue or omentum and distended surrounding bowel⁽¹⁶⁾.So failed interventional radiology drainage is not dangerous and can be well treated by surgery either open or laparoscopy- this is an important part of the message.

The length of hospital stay in laparoscopic group was shorter than interventional radiology because in laparoscopic group we removed the source of sepsis, peritoneal wash, therefore helped thepatient to recover rapidly. However, in interventional radiology group, we placed US or CT guided drain and waited several days for the pus to come out and daily wash with metronidazole and garamycine, so this prolonged the time needed for the patients to recover and all over length of hospital stay. The cost in laparoscopy group is less because the patients had shorted length of hospital stay but in interventional group, patient needed longer hospital stay for close observation and another admission, later on, for interval appendectomy.In our study, in interventional radiology group, 13 patients needs surgery immediately as they were not improved, the remaining patients during period of follow up, some of them still complain with recurrent attack of pain at right iliac fossa which improved by analgesics ( chronic appendicitis) but without toxic manifestations, US or CT finding reported remnant appendicular stump, they were subjected to elective laparoscopic appendectomy

In good experienced hands in laparoscopy, the conversion to open is extremely rare and we did not experience any conversions, while in interventional radiology group, there were 13 patients converted to surgery either laparoscopic or open surgery as the abscess was in accessible or small in size. According to World Journal of Emergency Surgery guidelines: Regarding non-operative treatment of acute appendicitis, antibiotic therapy can be successful in selected patients with uncomplicated appendicitis who wish to avoid surgery and accept the risk up to 38% recurrence. Percutaneous drainage of a periappendiceal abscess, if accessible, is an appropriate treatment in addition to antibiotics for complicated appendicitis. Non-operative management( Percutaneous drainage plus antibiotics ) is a reasonable first line treatment for appendicitis with phlegmon or abscess. Operative management of acute appendicitis with phlegmon or abscess can be a safe alternative to non-operative management but only in experienced hands⁽¹⁷⁾.

The quality of life was better in laparoscopic group ,criteria that were used to assess the quality of life were absence of recurrent pain at right iliac fossa, patients without any discomfort and needs for further management ⁽¹⁸⁾.

Laparoscopic management of appendicular abscess can be safely applied in a good experienced hand with no mortality & morbidity, without the need for interval appendectomy.

ASA: American Society of Anesthesia

IG: interventional group

SG: surgical group

PC : percutaneous

Availability of data & materials: All data generated during this study are included in this published article. Further minor datasets are available from the corresponding author on reasonable request.

Contributions: The manuscript has been read and approved by all the authors; the requirements for authorship have been met; each author believes that the manuscript represents honest work. Said Negm, Ahmed Farag and Ahmed Shafiq were directly involved in the entire procedure and designed the clinical case. Bassam Moussa screened the literature. Eslam Abozied and Mohamed Abozied were responsible for data acquisition and creation of supplementary information files. EslamAbozied, Said Negm, Ahmed Farag, Adel Attia, Ehab Shehata ,Bassam Moussa and Mohamed Abozied were involved in manuscript preparation. Ahmed Farag was involved in critical revision, editing and reviewing of the paper. All authors read and approved the final manuscript.

Funding information:This study did not have any internal or extramural funding.

Conflicts of interest: The authors have no relevant financial interest or conflicts of interest to disclose.

Consent for publication: no human identity revealing data is used in the study. all authors agree and no conflicts regarding publication.

Ethics state: Informed consent: was obtained from all individual participants included in the study.”This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 55342/24.1.2020) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects.

Acknowledgement: not applicable

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	Laparoscopic Drainage	Interventional Radiology	p value
Sex	N(%)	N(%)
Male	48(55.8)	44(51.2)	0.541
Female	38(44.2)	42(48.8)	0.541
Clinical presentation	N(%)	N(%)
Nausea	43(50)	36(41.9)	0.284
Vomiting	39(45.3)	35(40.7)	0.538
Fever	38(44.2)	42(48.8)	0.541
Right iliac fossa pain	19(22.1)	24(27.9)	0.379
Tender at RIF	22(25.6)	24(27.9)	0.73
Rebound tenderness	22(25.6)	14(16.3)	0.134
Mass felt	18(20.9)	15(17.4)	0.561
US finding positive	N(%)	N(%)
Negative	62(72.1)	61(70.9)	0.866
Positive	24(27.9)	25(29.1)	0.866
CT finding	N(%)	N(%)
Negative	24(27.9)	25(29.1)	0.866
Positive	62(72.1)	61(70.9)	0.866
Size of appendicular abcess	N(%)	N(%)
Small (1-2 cm)	22(25.6)	18(20.9)	0.723
Moderate (2-4 cm)	30(34.9)	34(39.5)
Large (4-7 cm)	34(39.5)	34(39.5)

Chi square test of significance used

Table 1.Demographic criteria, clinical presentation, US&CT finding, size of appendicular abscess in both group.

	Laparoscopic Drainage	Interventional Radiology	p value
Conversion to open	N(%)	N(%)
Yes	0(0)	13(15.1)	<0.001
No	86(100)	73(84.9)	<0.001
Needs further operation	N(%)	N(%)
Yes	0(0)	86(100)	<0.001
No	86(100)	0(0)	<0.001
Mortality	N(%)	N(%)
Yes	0(0)	1(1.2)	1*
No	86(100)	85(98.8)	1*
Complications	N(%)	N(%)
No	82(95.3)	70(81.4)	0.004
Bowel injury	1(1.2)	5(5.8)	*0.21
Fecal fistula	3(3.5)	0(0)	*0.246
Recurrence	0(0)	3(3.5)	*0.246
Pelvic collection	0(0)	8(9.3)	*0.007
Quality of life	N(%)	N(%)
Excellent	48(55.8)	12(14)	0.002
Good	38(44.2)	59(68.6)	<0.001
Poor	0(0)	15(17.4)	0.012

Chi square test of significance used

*Fisher exact used

Table2.conversion to open , need for further operation , complications , mortality , quality of life in both groups.

	Laparoscopic Drainage	Interventional Radiology	p value
	N(%)	N(%)
Age in years Mean±SD	41.2±12.2	36.8±10.9	0.013
hospital stay in days Median(IQR)	6(5:7)	15(13:17)	<0.001

Table 3.Hospital stay & age in both groups.

Quality of life	N(%)	N(%)	Relative risk	95% CI
Excellent	48(55.8)	12(14)	2.25	1.5-3.4	0.002
Good	38(44.2)	59(68.6)	1.25	1.1-1.4	<0.001
Poor	0(0)	15(17.4)			0.012

Table 4.Quality of life in both groups.

No competing interests reported.

Download PDF

Journal Publication

published 22 Mar, 2024

Read the published version in The Egyptian Journal of Surgery →

Version 1

posted

You are reading this latest preprint version

Laparoscopic Drainage Versus Interventional Radiology for Management Of Appendicular Abscess : A Randomized Controlled Trial

Status:

Journal Publication

Version 1

Abstract

Background:

Methods:

Results:

Conclusion:

Introduction

Patients And Methods

Patients

Diagnosis

Intervention

Statistical analysis:

Results

Discussion

Conclusion

Abbreviations

Declarations

References

Tables

Additional Declarations

Status:

Journal Publication

Version 1