Acute AppendicitisNCT03198065
Single-incision Laparoscopic Surgery in Acute Abdomen
A study testing Hand-made glove setting and Commercialized single-incision multiport setting in people with Acute Appendicitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally invasive surgery has become the main stay for treating of many surgical diseases. After the booming in the advancement of surgical instrument and breakthrough in surgical skills, the minimally invasive surgery has been widely… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Hand-made glove setting and Commercialized single-incision multiport setting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jun 2017to Jul 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients admitted to the NTUH Yunlin branch diagnosed clinically as acute appendicitis
- The patients with clinically suspected right lower quadrant pain and acute appendicitis could not be excluded
Who cannot join
- Not eligible to underwent laparoscopic surgery because of compromised cardiopulmonary function or major laparotomy surgery
- Decide to receive non-surgical treatment of the acute appendicitis
- Age<20, or could not exercise the right of autonomy or unwilling to participate the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yu-tso Liao, M.D., 886-972-655-738, Yutsoliao@gmail.com
About this study
Official title: The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen
Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally invasive surgery has become the main stay for treating of many surgical diseases. After the booming in the advancement of surgical instrument and breakthrough in surgical skills, the minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast, thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and effective, and further it achieves compatible results and outcomes in oncology and functional diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy, and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel disease). Under a superior heritage of surgical skills from Taiwan university hospital, we introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years, single-incisional laparoscopic surgery has emerged to become one of the focused topic in the world and seemly in our department. Through single-incision surgery, we attempted to minimize the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate two-step plans: first, by retrospective data collection, we can explain the clinical problems based on current statistical results. Second, based on prior (step 1) retrospective findings, a prospective study could be conducted for more evident results.
Read the detailed description
The aim of this study is to compare two kinds of single-incision laparoscopic surgery setting including hand-made glove setting and commercialized single-incision multiport setting. The preoperative, intraoperative and postoperative data will be collected for analysis.
- Conditions
- Acute Appendicitis
- Being tested
- Hand-made glove setting, Commercialized single-incision multiport setting
- Keywords
- Laparoscopic appendectomy, Single-incision laparoscopic appendectomy, Single-incision laparoscopic surgery setting, Simple appendicitis, Complicated appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-made glove settingProcedure or surgery
The patients receive Hand-made glove setting for single-incision laparoscopic appendectomy
Commercialized single-incision multiport settingProcedure or surgery
The patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy
| Study group | Role | What they receive |
|---|---|---|
| Hand-made glove setting | Experimental | The patients receive Hand-made glove setting Receives: Procedure: Hand-made glove setting |
| commercialized multiport setting | Experimental | The patients receive commercialized single-incision multiport setting Receives: Procedure: Commercialized single-incision multiport setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain is measured by visual pain scale
Measured: around 2 years
wound cosmesis
The cosmesis is measure by the length of the incision
Measured: around 2 years
Secondary outcomes (8)
Operative time
By chart review
Measured: around 2 years
Visceral/vascular injuries
Recorded on the operative note
Measured: around 2 years
Conversion
Recorded on the operative note
Measured: around 2 years
Wound infection/surgical site infection
By chart review
Measured: around 2 years
Intra-abdominal collection
Defined by evidence on any image modalities
Measured: around 2 years
Postoperative ileus
Defined by ileus physically or by image
Measured: around 2 years
Length of hospitalization
By chart review
Measured: around 2 years
Time to return work
By chart review
Measured: around 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start17 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peng-shen Lai, M.D., Study director, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198065
- Sponsor's protocol ID
- 201702076RIND
- Status last verified
- Jun 2017
- First submitted
- 18 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen
- ClinicalTrials.gov ID
- NCT03198065
- Acronym / sponsor ID
- 201702076RIND
- Conditions
- Acute Appendicitis
- Keywords
- Laparoscopic appendectomy, Single-incision laparoscopic appendectomy, Single-incision laparoscopic surgery setting, Simple appendicitis, Complicated appendicitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 23 Jun 2017 (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.
Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally invasive surgery has become the main stay for treating of many surgical diseases. After the booming in the advancement of surgical instrument and breakthrough in surgical skills, the minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast, thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and effective, and further it achieves compatible results and outcomes in oncology and functional diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy, and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel disease). Under a superior heritage of surgical skills from Taiwan university hospital, we introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years, single-incisional laparoscopic surgery has emerged to become one of the focused topic in the world and seemly in our department. Through single-incision surgery, we attempted to minimize the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate two-step plans: first, by retrospective data collection, we can explain the clinical problems based on current statistical results. Second, based on prior (step 1) retrospective findings, a prospective study could be conducted for more evident results.
Detailed description
The aim of this study is to compare two kinds of single-incision laparoscopic surgery setting including hand-made glove setting and commercialized single-incision multiport setting. The preoperative, intraoperative and postoperative data will be collected for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand-made glove setting | Experimental | Procedure: Hand-made glove settingThe patients receive Hand-made glove setting |
| commercialized multiport setting | Experimental | Procedure: Commercialized single-incision multiport settingThe patients receive commercialized single-incision multiport setting |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients admitted to the NTUH Yunlin branch diagnosed clinically as acute appendicitis
- The patients with clinically suspected right lower quadrant pain and acute appendicitis could not be excluded
Key exclusion criteria (3 listed)
- Not eligible to underwent laparoscopic surgery because of compromised cardiopulmonary function or major laparotomy surgery
- Decide to receive non-surgical treatment of the acute appendicitis
- Age<20, or could not exercise the right of autonomy or unwilling to participate 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 |
|---|---|---|
| Hand-made glove settingThe patients receive Hand-made glove setting for single-incision laparoscopic appendectomy | Procedure or surgery | Hand-made glove setting |
| Commercialized single-incision multiport settingThe patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy | Procedure or surgery | commercialized multiport setting |
Primary outcome
Postoperative pain
Time frame: around 2 years
Postoperative pain is measured by visual pain scale
wound cosmesis
Time frame: around 2 years
The cosmesis is measure by the length of the incision
8 secondary outcomes
Operative time
Time frame: around 2 years
Visceral/vascular injuries
Time frame: around 2 years
Conversion
Time frame: around 2 years
Wound infection/surgical site infection
Time frame: around 2 years
Intra-abdominal collection
Time frame: around 2 years
Postoperative ileus
Time frame: around 2 years
Length of hospitalization
Time frame: around 2 years
Time to return work
Time frame: around 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- 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.
Peng-shen Lai, M.D. study director
National Taiwan University Hospital, Yun-Lin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-made glove setting and Commercialized single-incision multiport setting in people with Acute Appendicitis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 23 Jun 2017. 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 Taiwan. 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 Yu-tso Liao, M.D. (886-972-655-738, Yutsoliao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: around 2 years). 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 23 Jun 2017.