Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy

Obesity Clinical Trial

Official title:

Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434988
• Other study ID #: 4245/2020
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: August 26, 2021

Study information

• Verified date: June 2022
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 26, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute
• Obesity

Intervention

Procedure:
• appendectomy
Open or Laparoscopic appendectomy procedure is typically performed under general anaesthesia. in the laparoscopic approach, the main principle is the triangulation of instrument ports to visualize and expose the appendix clearly. The first trocar (10 mm) for the optical device is introduced peri-umbilically, followed by two 5 mm trocars, one in the right lower quadrant just above the pubis (to grasp the appendix) and the other in the left iliac fossa (for the (right-handed) surgeon's right hand), assuming the appendix is in its normal anatomic position. The locations of the 5 mm trocars can be changed based on the anatomic position of the appendix as determined before to surgery (for example a subhepatic appendix could lead to placing the trocars as for cholecystectomy)

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The grade of The Clavien-Dindo for postoperative complications	compare the laparoscopic appendectomy vs. Open appendectomy in terms of intraoperative and postoperative complications during the 30 days postoperative (The Clavien-Dindo )	30 days
Primary	The score for quality of life	the postoperative quality of life has been compared between both groups using SF-36 scoring questionnaire. The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). The higher scores mean better quality of life..	30 days