Clinical trial NCT05434988: Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy
Official title: Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Appendicitis Acute
Keywords: Appendicitis
Obesity
laparoscopic appendectomy
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: obese patients (body mass index \>30kg/m2) who were diagnosed with acute appendicitis according to ALVARDO score at the department of surgery at Suez Canal university hospitals

Brief summary: Although obesity is a popular reason for choosing laparoscopic appendectomy (LA) versus open appendectomy (OA), however, the question of whether there is a difference remains. The goal of the present study is to investigate if there is a difference between OA and LA in obese patients. In the present study, Fifty-eight obese patients were diagnosed with acute appendicitis according to Alvarado score at the department of surgery at Suez Canal university hospitals from March 2020 till August 2021were included. The study participants were assigned to two groups, after their approval: LA and OA. The investigators hypothesized that evaluating the Outcome and Quality of life of laparoscopic appendectomy for the obese patients would be a potential step for standardization of the laparoscopic approach for obese patients who are arranged for appendectomy.

Detailed description: Although obesity is a popular reason for choosing laparoscopic appendectomy (LA) versus open appendectomy (OA), however, the question of whether there is a difference remains. The investigators' goal is to investigate if there is a difference between OA and LA in obese patients. Fifty-eight obese patients were diagnosed with acute appendicitis according to Alvarado score at the department of surgery at Suez Canal university hospitals from March 2020 till August 2021were included. The study participants were assigned to two groups, LA and OA. This study aimed to compare LA and OA regarding intraoperative complications, length of hospital stays, post-operative pain, and rate of postoperative complications. Meanwhile, using the SF-36 scoring questionnaire, the quality of life was compared between both groups.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18-40 years, with BMI ≥ 30 kg/m2 and diagnosed as acute appendicitis according to Alvarado score i.e., history of right lower quadrant pain or peri-umbilical pain shifting to the right lower quadrant with nausea and/or vomiting, fever of more than 38ºC, right lower quadrant guarding, and tenderness on physical examination and/or leukocytosis above 10,000 cells per ml were included.

Exclusion Criteria:

* The investigators excluded patients with a bleeding tendency., previous lower abdominal surgery, abdominal tuberculosis, mass formation either clinically or by ultrasound, end-stage renal disease (ESRD) patients, and patients who refused to participate in the study

Primary outcomes:
measure: The grade of The Clavien-Dindo for postoperative complications
timeFrame: 30 days
measure: The score for quality of life
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez canal University, Faculty of Medicine
name: Ahmed H Hussein, MD, PhD
role: STUDY_DIRECTOR
References: