CholelithiasisNCT01824186
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
A study testing SILC and LC in people with Cholelithiasis and Choledocholithiasis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cholelithiasis, Choledocholithiasis, Cholecystolithiasis
- What is being tested?
- SILC and LC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2010to Oct 2012
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of symptomatic gallstones
- American Society of Anesthesiologists (ASA) score 1 or 2
- informed consent
Who cannot join
- active acute cholecystitis
- previous open upper abdominal surgery
- bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.
Read the detailed description
As above
- Being tested
- SILC, LC
- Medical subject headings
- Cholelithiasis, Choledocholithiasis, Cholecystolithiasis, Pancreatitis, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILCProcedure or surgery
Also called Single-incision laparoscopic cholecystectomy
Underwent single-incision laparoscopic cholecystectomy
LCProcedure or surgery
Also called Conventional laparoscopic cholecystectomy
Underwent conventional 4-port laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| SILC | Experimental | Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision Receives: Procedure: SILC |
| LC | Active comparator | Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank Receives: Procedure: LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain 4 hours
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Measured: 4 hours post-operative
Post-operative pain 24 hours
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Measured: 24 hours post-operative
Post-operative pain 14 days
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Measured: 14 days post-operative
Post-operative pain 6 months
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Measured: 6 months post-operative
Secondary outcomes (4)
Procedural complications
To evaluate complications between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Conducted via telephone interview and review of hospital records in the intervening period
Measured: 6 months
Operative duration
To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique
Measured: following skin closure
Subject satisfaction
To evaluate subject satisfaction between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured on a Likert scale, from 1-5 (1 least satisfied, 5 most satisfied)
Measured: 14 days and 6 months
Return to function
To evaluate post-operative return to function following surgery, between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured as days taken to independent toileting, and independently obtaining meals as a surrogate measure of function
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 posted4 Apr 2013 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
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 CholelithiasisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Kin Yong Chang, FRCS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824186
- Sponsor's protocol ID
- NHG DSRB 2009/00434
- Status last verified
- Mar 2013
- First submitted
- 21 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chang SK, Wang YL, Shen L, Iyer SG, Madhavan K. A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. World J Surg. 2015 Apr;39(4):897-904. doi: 10.1007/s00268-014-2903-6.
PubMed 25446490
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01824186
- Acronym / sponsor ID
- NHG DSRB 2009/00434
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Apr 2013 (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.
This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.
Detailed description
As above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILC | Experimental | Procedure: SILCSubjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision |
| LC | Active comparator | Procedure: LCSubjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of symptomatic gallstones
- American Society of Anesthesiologists (ASA) score 1 or 2
- informed consent
Key exclusion criteria (3 listed)
- active acute cholecystitis
- previous open upper abdominal surgery
- bleeding disorders
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 |
|---|---|---|
| SILCAlso: Single-incision laparoscopic cholecystectomyUnderwent single-incision laparoscopic cholecystectomy | Procedure or surgery | SILC |
| LCAlso: Conventional laparoscopic cholecystectomyUnderwent conventional 4-port laparoscopic cholecystectomy | Procedure or surgery | LC |
Primary outcome
Post-operative pain 4 hours
Time frame: 4 hours post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 24 hours
Time frame: 24 hours post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 14 days
Time frame: 14 days post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 6 months
Time frame: 6 months post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
4 secondary outcomes
Procedural complications
Time frame: 6 months
Operative duration
Time frame: following skin closure
Subject satisfaction
Time frame: 14 days and 6 months
Return to function
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 4 Apr 2013.
- Derived from this study: PubMed 25446490Chang SK, Wang YL, Shen L, Iyer SG, Madhavan K. A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. World J Surg. 2015 Apr;39(4):897-904. doi: 10.1007/s00268-014-2903-6.
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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.
Stephen Kin Yong Chang, FRCS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SILC and LC in people with Cholelithiasis and Choledocholithiasis, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 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 4 Apr 2013. 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 Singapore. 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?
Post-operative pain 4 hours (time frame: 4 hours post-operative). The study lists 4 primary outcomes in all. 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 NCT01824186, 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 4 Apr 2013.