ComplicationsNCT02499016
Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial
A study testing suprapubic single-incision laparoscopic appendectomy in people with Complications, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications
- What is being tested?
- suprapubic single-incision laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute appendicitis or interval appendicitis
- informed consent
Who cannot join
- diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems)
- history of cirrhosis and coagulation disorders
- suspected or proven malignancy
- contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- inability to give informed consent(severe mental disease)
- pregnancy
- BMI>30kg/m2
- generalized peritonitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515
Guoxin Li, M.D., Ph.D., +86-138-0277-1450, gzliguoxin@163.com
Yanan Wang, M.D., +86-150-1875-3181, wyn8116@163.com
About this study
Official title: Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Multiport Appendectomy: a Randomized Controlled Trial
Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.
- Conditions
- Complications
- Being tested
- suprapubic single-incision laparoscopic appendectomy
- Keywords
- Appendicitis, Appendectomy, Single-incision
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprapubic single-incision laparoscopic appendectomyProcedure or surgery
Also called SSILA
the approach of appendectomy
| Study group | Role | What they receive |
|---|---|---|
| suprapubic single-incision laparoscopic appendectomy | Experimental | single incision laparoscopic surgery will be performed for patients in this group. Receives: Procedure: suprapubic single-incision laparoscopic appendectomy |
| conventional multiport appendectomy | Active comparator | Conventional laparoscopic surgery will be performed for patients in this group. Receives: Procedure: suprapubic single-incision laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of complications
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
Measured: 30 days
Secondary outcomes (5)
mortality rate
Measured: 30 days
cosmetic results
Cosmetic assessment is perform using body image scale and cosmetic scale.
Measured: 30 days
operative time
Measured: intraoperative
time to recover
Measured: 14 days
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoxin Li, M.D.,Ph. D., Principal investigator, Nanfang Hospital, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499016
- Sponsor's protocol ID
- NFGS-SSILA-01
- Status last verified
- Mar 2015
- First submitted
- 10 Jun 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu J, Wang YN, Hu YF, Cheng X, Zhen L, Li GX. Single-incision laparoscopic appendectomy performed above the pubic symphysis - a new scarless approach. Minim Invasive Ther Allied Technol. 2011 Jan;20(1):18-21. doi: 10.3109/13645706.2010.518672.
PubMed 21222504Wang Y, Xiong W, Lan X, Zhang J, Chen T, Liu H, Li G. Suprapubic single incision laparoscopic appendectomy. J Surg Res. 2015 Feb;193(2):577-82. doi: 10.1016/j.jss.2014.07.064. Epub 2014 Aug 4.
PubMed 25179807
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Multiport Appendectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02499016
- Acronym / sponsor ID
- NFGS-SSILA-01
- Conditions
- Complications
- Keywords
- Appendicitis, Appendectomy, Single-incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jul 2015 (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.
Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suprapubic single-incision laparoscopic appendectomy | Experimental | Procedure: suprapubic single-incision laparoscopic appendectomysingle incision laparoscopic surgery will be performed for patients in this group. |
| conventional multiport appendectomy | Active comparator | Procedure: suprapubic single-incision laparoscopic appendectomyConventional laparoscopic surgery will be performed for patients in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute appendicitis or interval appendicitis
- informed consent
Key exclusion criteria (8 listed)
- diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems)
- history of cirrhosis and coagulation disorders
- suspected or proven malignancy
- contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- inability to give informed consent(severe mental disease)
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 |
|---|---|---|
| suprapubic single-incision laparoscopic appendectomyAlso: SSILAthe approach of appendectomy | Procedure or surgery | conventional multiport appendectomy, suprapubic single-incision laparoscopic appendectomy |
Primary outcome
incidence of complications
Time frame: 30 days
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
5 secondary outcomes
mortality rate
Time frame: 30 days
cosmetic results
Time frame: 30 days
operative time
Time frame: intraoperative
time to recover
Time frame: 14 days
Pain score
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Results publication: PubMed 21222504Yu J, Wang YN, Hu YF, Cheng X, Zhen L, Li GX. Single-incision laparoscopic appendectomy performed above the pubic symphysis - a new scarless approach. Minim Invasive Ther Allied Technol. 2011 Jan;20(1):18-21. doi: 10.3109/13645706.2010.518672.
- Results publication: PubMed 25179807Wang Y, Xiong W, Lan X, Zhang J, Chen T, Liu H, Li G. Suprapubic single incision laparoscopic appendectomy. J Surg Res. 2015 Feb;193(2):577-82. doi: 10.1016/j.jss.2014.07.064. Epub 2014 Aug 4.
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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.
Guoxin Li, M.D.,Ph. D. principal investigator
Nanfang Hospital, Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suprapubic single-incision laparoscopic appendectomy in people with Complications, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Jul 2015. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoxin Li, M.D.,Ph. D. (+86-138-0277-1450, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complications (time frame: 30 days). 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 NCT02499016, which also lists 2 linked publications.
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 15 Jul 2015.