AppendicitisPhase 3NCT01203566
A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.
A Phase 3 study testing LESS appendectomy and Conventional 3-port laparoscopic appendectomy in people with Appendicitis, run by Chinese University of Hong Kong at 2 sites in China.
Trial summary
LESS laparoscopic appendectomy is associated with less pain than conventional 3-port laparoscopic appendectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- LESS appendectomy and Conventional 3-port laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2009to Apr 2011
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant
- Fever ≥ 38°C and/or WCC > 10 X 103 cells per mL,
- Right lower quadrant guarding, and tenderness on physical examination.
- All patients included were 18-75 years old.
Who cannot join
- Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable to urinary or gynaecological problems).
- History of symptoms > 5 days and/or a palpable mass in the right lower quadrant, suggesting an appendiceal abscess treated with antibiotics and possible percutaneous drainage.
- Patients with the following conditions are also excluded: history of cirrhosis and coagulation disorders, generalized peritonitis, shock on admission, previous abdominal surgery, ascites, suspected or proven malignancy, contraindication to general anesthesia (severe cardiac and/or pulmonary disease), inability to give informed consent due to mental disability, and pregnancy.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Deparment of Surgery, North District Hospital, Sheung Shui
Hong Kong
Department of Surgery, Prince of Wales Hospital, Shatin
Hong Kong
About this study
Official title: A Double-blinded Randomised Controlled Trial of Laparoendoscopic Single-site Access (LESS) Versus Conventional Three-port Appendicectomy.
LESS laparoscopic appendectomy is associated with less pain than conventional 3-port laparoscopic appendectomy.
Read the detailed description
Since the original description in the 1970's, the laparoscopic approach to management of surgical diseases has gained widespread acceptance. It has been shown to be associated with decreased wound pain, analgesic requirements, hospital stay and allows improved cosmesis and quality of life without significantly increasing the risks of morbidities and mortalities. With continued improvements in technology, however, efforts to reduce the number of abdomen wounds in an attempt to further decrease pain, improve cosmesis and outcomes are underway. Natural Orifices Transluminal Endoscopic Surgery (NOTES) has received widespread attention in both the medical field as well as the general public. However, there are still a multitude of problems that needs to be solved before the technique can be broadly applied to human subjects [7]. On the other hand, a renewed interest in single incision laparoscopic surgeries is emerging. The approach has been shown to be safe and feasible in our experience as well as the others. It also has the potential to further decrease the surgical trauma induced to the patient and to improve cosmesis.
Since laparoscopic appendicectomy is one of the most basic procedures in laparoscopic surgery, it is an appropriate model for initial evaluation of single incision laparoscopic surgery. Our unit has already performed 20 cases of single site access laparoscopic appendicectomy (SSALA) and so far, the results have been encouraging (data pending publication). All the patients in the series had their procedures completed with a single incision. None of the patients suffered from adverse events and all had resumption of oral diet by day 1 and were discharged on day 2 post-operatively. However, whether the approach is more beneficial as compared to conventional three-port laparoscopic appendicectomy is still uncertain.
Hence, the aim of the current study is to compare the approach of SSALA to conventional three-port laparoscopic appendicectomy in reducing surgical trauma and improving cosmesis to the patient.
- Conditions
- Appendicitis
- Being tested
- LESS appendectomy, Conventional 3-port laparoscopic appendectomy
- Keywords
- Single incision laparoscopic surgery, Single site access laparoscopic surgery, SILS, Single-port access, Laparoendoscopic single site surgery, Appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LESS appendectomyProcedure or surgery
See under arms description
Conventional 3-port laparoscopic appendectomyProcedure or surgery
See under arms description
| Study group | Role | What they receive |
|---|---|---|
| Conventional 3-port laparoscopic appendectomy | Active comparator | Laparoscopic appendectomy will be performed with the standard 3-port technique. The laparoscope is introduced via a 10mm subumbilical port. Dissection will be performed with a 5mm LLQ port and a 5mm RLQ port. Exploratory laparoscopy was first carried out to locate the appendix and to rule out other pathologies. The mesoappendix will be divided with the ultrasonic dissector (Sonosurg, Olympus surgical, Tokyo, Japan). The appendix will be ligated between two polydioxanone suture loops. The specimen will be delivered within a plastic bag via the subumbilical port. Purulent fluid will be irrigated and suctioned from the subhepatic space, right lower quadrant and the pelvis if present. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbable subcuticular sutures. A pelvic drain (12Fr) will be inserted in cases of abscesses or gangrene. Receives: Procedure: Conventional 3-port laparoscopic appendectomy |
| LESS appendectomy | Active comparator | Two 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision. Exploratory laparoscopy was first carried out to locate the appendix and to rule out other pathologies. Retraction of the appendix would be performed with a flexible curved forceps. The mesoappendix will be divided with the ultrasonic dissector (Sonosurg, Olympus surgical, Tokyo, Japan). The appendix will be ligated between two polydioxanone suture loops. The specimen will be delivered within a plastic bag via the subumbilical port. Purulent fluid will be irrigated and suctioned from the subhepatic space, right lower quadrant and the pelvis if present. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbable subcuticular sutures. A pelvic drain (12Fr) will be inserted in cases of abscesses or gangrene. Receives: Procedure: LESS appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall pain score experienced by the patient within the last 24 hrs using the visual analogue scale
The main outcome is the overall pain score (measured as the most severe pain experienced within the last 24 hrs using the visual analogue scale) experienced by the patient after the operation
Measured: 1st post-operative day
Secondary outcomes (8)
Conversion
defined by the use of incisions and/or trocars in addition to the ones described in the Methods section, or the need to perform an open procedure
Measured: 24 hours
Operative time
defined as the amount of time to perform the operation from skin-incision to application of the dressing.
Measured: 24 hours
Wound infection
defined as presence of skin erythema, discharge and a positive culture
Measured: 14 days
Deep space infection
defined as the need for reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 30 days of surgery.
Measured: 30 days
activity score
defined by a composite score including 4 items using a five point scale: lying in bed, getting out of chair or bed, walking on level ground and climbing stairs [1. no difficulty; 2. a little difficult; 3. some difficulty; 4. a lot of difficulty; 5. not able to perform.]
Measured: 14 days
Satisfaction score
Overall satisfaction of the procedure by the patient measured with the visual analogue scale
Measured: 14 days
Cosmesis score
defined as the score given by the patient on the overall cosmesis of the wound measured by the visual analogue scale
Measured: 14 days
quality of life
measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeks follow-up
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 posted16 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Anthony Y Teoh, FRCSEd (Gen), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203566
- Sponsor's protocol ID
- CREC 2009.347
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pappalepore N, Tursini S, Marino N, Lisi G, Lelli Chiesa P. Transumbilical laparoscopic-assisted appendectomy (TULAA): a safe and useful alternative for uncomplicated appendicitis. Eur J Pediatr Surg. 2002 Dec;12(6):383-6. doi: 10.1055/s-2002-36846.
PubMed 12548490Hong TH, Kim HL, Lee YS, Kim JJ, Lee KH, You YK, Oh SJ, Park SM. Transumbilical single-port laparoscopic appendectomy (TUSPLA): scarless intracorporeal appendectomy. J Laparoendosc Adv Surg Tech A. 2009 Feb;19(1):75-8. doi: 10.1089/lap.2008.0338.
PubMed 19196084Chow A, Purkayastha S, Paraskeva P. Appendicectomy and cholecystectomy using single-incision laparoscopic surgery (SILS): the first UK experience. Surg Innov. 2009 Sep;16(3):211-7. doi: 10.1177/1553350609344413. Epub 2009 Aug 31.
PubMed 19723692Teoh AY, Chiu PW, Wong TC, Poon MC, Wong SK, Leong HT, Lai PB, Ng EK. A double-blinded randomized controlled trial of laparoendoscopic single-site access versus conventional 3-port appendectomy. Ann Surg. 2012 Dec;256(6):909-14. doi: 10.1097/SLA.0b013e3182765fcf.
PubMed 23154391
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Randomised Controlled Trial of Laparoendoscopic Single-site Access (LESS) Versus Conventional Three-port Appendicectomy.
- ClinicalTrials.gov ID
- NCT01203566
- Acronym / sponsor ID
- CREC 2009.347
- Conditions
- Appendicitis
- Keywords
- Single incision laparoscopic surgery, Single site access laparoscopic surgery, SILS, Single-port access, Laparoendoscopic single site surgery, Appendectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 16 Sep 2010 (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.
LESS laparoscopic appendectomy is associated with less pain than conventional 3-port laparoscopic appendectomy.
Detailed description
Since the original description in the 1970's, the laparoscopic approach to management of surgical diseases has gained widespread acceptance. It has been shown to be associated with decreased wound pain, analgesic requirements, hospital stay and allows improved cosmesis and quality of life without significantly increasing the risks of morbidities and mortalities. With continued improvements in technology, however, efforts to reduce the number of abdomen wounds in an attempt to further decrease pain, improve cosmesis and outcomes are underway. Natural Orifices Transluminal Endoscopic Surgery (NOTES) has received widespread attention in both the medical field as well as the general public. However, there are still a multitude of problems that needs to be solved before the technique can be broadly applied to human subjects [7]. On the other hand, a renewed interest in single incision laparoscopic surgeries is emerging. The approach has been shown to be safe and feasible in our experience as well as the others. It also has the potential to further decrease the surgical trauma induced to the patient and to improve cosmesis.
Since laparoscopic appendicectomy is one of the most basic procedures in laparoscopic surgery, it is an appropriate model for initial evaluation of single incision laparoscopic surgery. Our unit has already performed 20 cases of single site access laparoscopic appendicectomy (SSALA) and so far, the results have been encouraging (data pending publication). All the patients in the series had their procedures completed with a single incision. None of the patients suffered from adverse events and all had resumption of oral diet by day 1 and were discharged on day 2 post-operatively. However, whether the approach is more beneficial as compared to conventional three-port laparoscopic appendicectomy is still uncertain.
Hence, the aim of the current study is to compare the approach of SSALA to conventional three-port laparoscopic appendicectomy in reducing surgical trauma and improving cosmesis to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional 3-port laparoscopic appendectomy | Active comparator | Procedure: Conventional 3-port laparoscopic appendectomyLaparoscopic appendectomy will be performed with the standard 3-port technique. The laparoscope is introduced via a 10mm subumbilical port. Dissection will be performed with a 5mm LLQ port and a 5mm RLQ port. Exploratory laparoscopy was first carried out to locate the appendix and to rule out other pathologies. The mesoappendix will be divided with the ultrasonic dissector (Sonosurg, Olympus surgical, Tokyo, Japan). The appendix will be ligated between two polydioxanone suture loops. The specimen will be delivered within a plastic bag via the subumbilical port. Purulent fluid will be irrigated and suctioned from the subhepatic space, right lower quadrant and the pelvis if present. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbable subcuticular sutures. A pelvic drain (12Fr) will be inserted in cases of abscesses or gangrene. |
| LESS appendectomy | Active comparator | Procedure: LESS appendectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision. Exploratory laparoscopy was first carried out to locate the appendix and to rule out other pathologies. Retraction of the appendix would be performed with a flexible curved forceps. The mesoappendix will be divided with the ultrasonic dissector (Sonosurg, Olympus surgical, Tokyo, Japan). The appendix will be ligated between two polydioxanone suture loops. The specimen will be delivered within a plastic bag via the subumbilical port. Purulent fluid will be irrigated and suctioned from the subhepatic space, right lower quadrant and the pelvis if present. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbable subcuticular sutures. A pelvic drain (12Fr) will be inserted in cases of abscesses or gangrene. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant
- Fever ≥ 38°C and/or WCC > 10 X 103 cells per mL,
- Right lower quadrant guarding, and tenderness on physical examination.
- All patients included were 18-75 years old.
Key exclusion criteria (3 listed)
- Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable to urinary or gynaecological problems).
- History of symptoms > 5 days and/or a palpable mass in the right lower quadrant, suggesting an appendiceal abscess treated with antibiotics and possible percutaneous drainage.
- Patients with the following conditions are also excluded: history of cirrhosis and coagulation disorders, generalized peritonitis, shock on admission, previous abdominal surgery, ascites, suspected or proven malignancy, contraindication to general anesthesia (severe cardiac and/or pulmonary disease), inability to give informed consent due to mental disability, and pregnancy.
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 |
|---|---|---|
| LESS appendectomySee under arms description | Procedure or surgery | LESS appendectomy |
| Conventional 3-port laparoscopic appendectomySee under arms description | Procedure or surgery | Conventional 3-port laparoscopic appendectomy |
Primary outcome
Overall pain score experienced by the patient within the last 24 hrs using the visual analogue scale
Time frame: 1st post-operative day
The main outcome is the overall pain score (measured as the most severe pain experienced within the last 24 hrs using the visual analogue scale) experienced by the patient after the operation
8 secondary outcomes
Conversion
Time frame: 24 hours
Operative time
Time frame: 24 hours
Wound infection
Time frame: 14 days
Deep space infection
Time frame: 30 days
activity score
Time frame: 14 days
Satisfaction score
Time frame: 14 days
Cosmesis score
Time frame: 14 days
quality of life
Time frame: 14 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 21 Jul 2011.
- Background: PubMed 12548490Pappalepore N, Tursini S, Marino N, Lisi G, Lelli Chiesa P. Transumbilical laparoscopic-assisted appendectomy (TULAA): a safe and useful alternative for uncomplicated appendicitis. Eur J Pediatr Surg. 2002 Dec;12(6):383-6. doi: 10.1055/s-2002-36846.
- Background: PubMed 19196084Hong TH, Kim HL, Lee YS, Kim JJ, Lee KH, You YK, Oh SJ, Park SM. Transumbilical single-port laparoscopic appendectomy (TUSPLA): scarless intracorporeal appendectomy. J Laparoendosc Adv Surg Tech A. 2009 Feb;19(1):75-8. doi: 10.1089/lap.2008.0338.
- Background: PubMed 19723692Chow A, Purkayastha S, Paraskeva P. Appendicectomy and cholecystectomy using single-incision laparoscopic surgery (SILS): the first UK experience. Surg Innov. 2009 Sep;16(3):211-7. doi: 10.1177/1553350609344413. Epub 2009 Aug 31.
- Derived from this study: PubMed 23154391Teoh AY, Chiu PW, Wong TC, Poon MC, Wong SK, Leong HT, Lai PB, Ng EK. A double-blinded randomized controlled trial of laparoendoscopic single-site access versus conventional 3-port appendectomy. Ann Surg. 2012 Dec;256(6):909-14. doi: 10.1097/SLA.0b013e3182765fcf.
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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.
Anthony Y Teoh, FRCSEd (Gen) principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LESS appendectomy and Conventional 3-port laparoscopic appendectomy in people with Appendicitis, run by Chinese University of Hong Kong at 2 sites 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 4 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: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall pain score experienced by the patient within the last 24 hrs using the visual analogue scale (time frame: 1st post-operative day). 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 NCT01203566, which also lists 4 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 21 Jul 2011.