Clinical trial NCT06718595: Study of Management of Appendicular Abscess
Official title: Evaluation of Percutaneous Drainage of Appendicular Abscess, is There Any Need for Further Open Drainage ?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Appendiceal Abscess
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include 100 patients was diagnosed with appendicular abscess in the emergency unit, department of general surgery, faculty of medicine, Assiut university

Brief summary: This study aims to detect indications of surgical drainage after failure Ultrasound guided percutaneous drainage This study will include any male and female above 18 years old that presented with appendicular abscess Patients with appendicular abscess above the age of 18 years old All patients with generalized peritonitis or immunocompromised patients will be excluded from the study

Detailed description: Prospective randomized study we will collect 30 patients diagnosed with appendicular abscess and they all will undergo Ultrasound guided percutaneous drainage of abscess and the group who will fail to insert the pigtail will undergo surgical drainage we will record the time of operation, number of cases with intraoperative complications and then follow up these patients during time of hospital stay for post operative pain and paralytic ileus

Study outcomes:

Primary outcomes:

1. Incidence of intra operative complications
2. Length of operations
3. Post operative pain
4. Incidence of intraoperative complications as injury of important structures
5. Lenght of hospital stay
6. Incidence of post operative complications related to surgery as wound infection, recurrence, intestinal obstruction

Secondary outcomes:

1. Cosmotic outcomes
2. Incidence of recurrence of pathology
3. Patient satisfaction

Eligibility criteria: Inclusion Criteria:

* Patients with appendicular abscess above the age of 18 years old

Exclusion Criteria:

* Generalized peritonitis and patients with signs of spreading infection, toxemia and septicemia Multi-locular appendicular abscess Immunocompromised patients, hepatic dysfunction, renal impairment, uncontrolled patients and cardiac disease

Primary outcomes:
measure: 1-Incidence of intraoperative complications
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Brown C, Kang L, Kim ST. Percutaneous drainage of abdominal and pelvic abscesses in children. Semin Intervent Radiol. 2012 Dec;29(4):286-94. doi: 10.1055/s-0032-1330062.
citation: Darwazeh G, Cunningham SC, Kowdley GC. A Systematic Review of Perforated Appendicitis and Phlegmon: Interval Appendectomy or Wait-and-See? Am Surg. 2016 Jan;82(1):11-5.
citation: Tannoury J, Abboud B. Treatment options of inflammatory appendiceal masses in adults. World J Gastroenterol. 2013 Jul 7;19(25):3942-50. doi: 10.3748/wjg.v19.i25.3942.
citation: Deelder JD, Richir MC, Schoorl T, Schreurs WH. How to treat an appendiceal inflammatory mass: operatively or nonoperatively? J Gastrointest Surg. 2014 Apr;18(4):641-5. doi: 10.1007/s11605-014-2460-1. Epub 2014 Feb 4.
citation: Bal A, Ozkececi ZT, Turkoglu O, Ozsoy M, Celep RB, Yilmaz S, Arikan Y. Demographic characteristics and seasonal variations of acute appendicitis. Ann Ital Chir. 2015;86:539-44.