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

NCT05434988 | Completed

• 1 other identifier: 4245/2020
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Appendicitis Acute

Keywords

Appendicitis; Obesity; laparoscopic appendectomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Laparoscopic appendectomy

The laparoscopic appendectomy group is the group that includes patients who underwent appendectomy using the laparoscopic approach

Procedure: appendectomy

Open appendectomy

The open appendectomy group is the group that includes patients who underwent appendectomy using laparoscopic approach

Procedure: appendectomy

Interventions

appendectomy PROCEDURE

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)

Laparoscopic appendectomy; Open appendectomy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Obesity; Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmed H Hussein, MD, PhD

  Suez canal University, Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: March 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 26, 2021
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)