AppendicitisNCT01007318
Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis
A study testing Single port laparoscopic appendectomy and 3 port laparoscopic appendectomy in people with Appendicitis, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis. Read more about this study
- Who is it for?
- Ages 7 to 75 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Single port laparoscopic appendectomy and 3 port laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Feb 2016
- Phase
- Interventional
- 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 7 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically diagnosed acute appendicitis
Who cannot join
- Age less than 7 or more than 75 years old
- Gangrenous appendicitis
- Combined generalized peritonitis
- ASA score more than 3 point
- Pregnant women
- Cases requiring draining tube
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University School of Medicine, Neo Medical Center
Seoul, 134-727
About this study
Official title: Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis
The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.
Read the detailed description
Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.
- Conditions
- Appendicitis
- Being tested
- Single port laparoscopic appendectomy, 3 port laparoscopic appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single port laparoscopic appendectomyProcedure or surgery
Also called single port laparoscopic surgery
Single port through the transumbilical 2-cm incision
3 port laparoscopic appendectomyProcedure or surgery
Also called conventional laparoscopic appendectomy
3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area
| Study group | Role | What they receive |
|---|---|---|
| Single port | Active comparator | Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it. Receives: Procedure: Single port laparoscopic appendectomy |
| 3 port | Active comparator | 3 port laparoscopic appendectomy was done by conventional method Receives: Procedure: 3 port laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
30 day morbidity and mortality
Measured: 1 month
Secondary outcomes (5)
Efficacy
Operative time
Measured: 1 day
Efficacy
Postoperative pain score
Measured: 2 days
Efficacy
Postoperative functional recovery
Measured: 2 days
Efficacy
Duration of postoperative hospital stay
Measured: 7 days
Efficacy
Cost
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KyungHee University School of Medicine, Korea
- Responsible party
- Principal investigator, Byung Mo Kang, Kyunghee University Medical Center
- Investigators
- Suk Hwan Lee, MD. PhD, Principal investigator, Kyung Hee University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007318
- Sponsor's protocol ID
- khnmc IRB 2009-026
- Status last verified
- Sep 2020
- First submitted
- 3 Nov 2009
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang BM, Choi SI, Kim BS, Lee SH. Single-port laparoscopic surgery in uncomplicated acute appendicitis: a randomized controlled trial. Surg Endosc. 2018 Jul;32(7):3131-3137. doi: 10.1007/s00464-018-6028-0. Epub 2018 Jan 16.
PubMed 29340826
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis
- ClinicalTrials.gov ID
- NCT01007318
- Acronym / sponsor ID
- khnmc IRB 2009-026
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- KyungHee University School of Medicine, Korea
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Nov 2009 (estimated)
- 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.
The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.
Detailed description
Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single port | Active comparator | Procedure: Single port laparoscopic appendectomySingle port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it. |
| 3 port | Active comparator | Procedure: 3 port laparoscopic appendectomy3 port laparoscopic appendectomy was done by conventional method |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed acute appendicitis
Key exclusion criteria (6 listed)
- Age less than 7 or more than 75 years old
- Gangrenous appendicitis
- Combined generalized peritonitis
- ASA score more than 3 point
- Pregnant women
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 |
|---|---|---|
| Single port laparoscopic appendectomyAlso: single port laparoscopic surgerySingle port through the transumbilical 2-cm incision | Procedure or surgery | Single port |
| 3 port laparoscopic appendectomyAlso: conventional laparoscopic appendectomy3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area | Procedure or surgery | 3 port |
Primary outcome
Safety
Time frame: 1 month
30 day morbidity and mortality
5 secondary outcomes
Efficacy
Time frame: 1 day
Efficacy
Time frame: 2 days
Efficacy
Time frame: 2 days
Efficacy
Time frame: 7 days
Efficacy
Time frame: 7 days
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 7 Sep 2020.
- Derived from this study: PubMed 29340826Kang BM, Choi SI, Kim BS, Lee SH. Single-port laparoscopic surgery in uncomplicated acute appendicitis: a randomized controlled trial. Surg Endosc. 2018 Jul;32(7):3131-3137. doi: 10.1007/s00464-018-6028-0. Epub 2018 Jan 16.
- Individual participant dataSharing planned: No
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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.
Suk Hwan Lee, MD. PhD principal investigator
Kyung Hee University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single port laparoscopic appendectomy and 3 port laparoscopic appendectomy in people with Appendicitis, run by Kyunghee University Medical Center at 1 site in South Korea.
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 6 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 7 Sep 2020. 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 South Korea. 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?
Safety (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007318, which also lists 1 linked publication.
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 7 Sep 2020.