ObesityNCT05434988
Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy
An observational study of Obesity and Appendicitis Acute, run by Suez Canal University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity, Appendicitis Acute
- What is being tested?
- appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 26 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Appendicitis Acute
- Being tested
- appendectomy
- Keywords
- Appendicitis, Obesity, laparoscopic appendectomy
- Medical subject headings
- Obesity, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendectomyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic appendectomy | The laparoscopic appendectomy group is the group that includes patients who underwent appendectomy using the laparoscopic approach Receives: Procedure: appendectomy | |
| Open appendectomy | The open appendectomy group is the group that includes patients who underwent appendectomy using laparoscopic approach Receives: Procedure: appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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..
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Mar 2020
- Primary completion30 Jun 2021
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ghareeb, Suez Canal University
- Investigators
- Ahmed H Hussein, MD, PhD, Study director, Suez canal University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434988
- Sponsor's protocol ID
- 4245/2020
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data are available with the principal investigator on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Quality of Life in Obese Patients Underwent Laparoscopic vs. Open Appendectomy
- ClinicalTrials.gov ID
- NCT05434988
- Acronym / sponsor ID
- 4245/2020
- Conditions
- Obesity, Appendicitis Acute
- Keywords
- Appendicitis, Obesity, laparoscopic appendectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic appendectomy | – | Procedure: appendectomyThe laparoscopic appendectomy group is the group that includes patients who underwent appendectomy using the laparoscopic approach |
| Open appendectomy | – | Procedure: appendectomyThe open appendectomy group is the group that includes patients who underwent appendectomy using laparoscopic approach |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| appendectomyOpen 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) | Procedure or surgery | Laparoscopic appendectomy, Open appendectomy |
Primary outcome
The grade of The Clavien-Dindo for postoperative complications
Time frame: 30 days
compare the laparoscopic appendectomy vs. Open appendectomy in terms of intraoperative and postoperative complications during the 30 days postoperative (The Clavien-Dindo )
The score for quality of life
Time frame: 30 days
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..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No. All data are available with the principal investigator on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed H Hussein, MD, PhD study director
Suez canal University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Appendicitis Acute, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The grade of The Clavien-Dindo for postoperative complications (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.