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Cholecystectomy, LaparoscopicNCT03018964

Solo Single Incision Laparoscopic Cholecystectomy

A study testing Solo surgery and operation with a camera operator in SILC in people with Cholecystectomy, Laparoscopic, run by Seoul National University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator assisted SILC Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholecystectomy, Laparoscopic
What is being tested?
Solo surgery and operation with a camera operator in SILC
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
No sites listed yet
Study dates
Mar 2020to Aug 2022
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

  • all patient need laparoscopic cholecystectomy (check the possibility of routine application of Solo-SILC in clinical practice)

Who cannot join

  • Mirizzi syndrome
  • unstable vital sign
  • no compliance
  • no consent

Trial locations and contacts

No sites are listed yet.

YoungRok Choi, M.D. contact

+821093212477

choiyoungrok@gmail.com

Ho-Jeong Jeong, R.N. contact

+821095267743

r1441@snubh.org

About this study

Official title: A Prospective Multicenter Randomized Controlled Study for The Safety of Single Incision Laparoscopic Cholecystectomy With a Camera Holder Versus With a Camera Operator

The purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator assisted SILC

Read the detailed description

This study is a multicenter randomized controlled study. The primary outcome based on non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between Solo-SILC group and conventional cholecystectomy group (Ca-SILC).

Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to two groups according to a computer-generated table of random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in which a camera operator joins (n=136). .

Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to open surgery or additional port will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy diarrhea, operator's workload will be investigated

Being tested
Solo surgery, operation with a camera operator in SILC
Keywords
Single incision, Solo surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solo surgeryProcedure or surgery

    Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy

  • operation with a camera operator in SILCProcedure or surgery

    conventional single incision laparoscopic cholecystectomy with a scopist

Study groups in NCT03018964
Study groupRoleWhat they receive
Solo-SILCExperimentalSolo surgery using a laparoscopic camera holder instead of a camera operator in SILC
Receives: Procedure: Solo surgery
Ca-SILCActive comparatorNo solo surgery, operation with a camera operator in SILC
Receives: Procedure: operation with a camera operator in SILC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)

    intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy

    Measured: average 2 weeks

Secondary outcomes (7)

  1. complications in both groups

    intraoperative and postoperative complications

    Measured: average 2 weeks

  2. Conversion rate

    intraoperative conversion rate to open or additional port surgery

    Measured: intraoperative

  3. Incisional hernia

    Umbilical incisional hernia incidence

    Measured: average 6 months

  4. Wound, back, and shoulder pain

    Access the patient's pain using the visual analog scale

    Measured: postoperative 6 hr, 24 hr, 2 weeks after the operation

  5. Postoperative adverse symptoms after SILC

    Diet change, post-cholecystectomy diarrhea

    Measured: average 2weeks after discharge

  6. number of participant with abnormal laboratory values

    postoperative laboratory findings on visiting outpatient's clinic

    Measured: average 2weeks after discharge

  7. Operator's workload

    Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study startMar 2020 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

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
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018964
Sponsor's protocol ID
SILC_HoOp
Status last verified
Apr 2019
First submitted
8 Jan 2017
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Navarra G, Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 May;84(5):695. No abstract available.

    PubMed 9171771

  • Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.

    PubMed 20174950

  • Marks J, Tacchino R, Roberts K, Onders R, Denoto G, Paraskeva P, Rivas H, Soper N, Rosemurgy A, Shah S. Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data. Am J Surg. 2011 Mar;201(3):369-72; discussion 372-3. doi: 10.1016/j.amjsurg.2010.09.012.

    PubMed 21367381

  • Markar SR, Karthikesalingam A, Thrumurthy S, Muirhead L, Kinross J, Paraskeva P. Single-incision laparoscopic surgery (SILS) vs. conventional multiport cholecystectomy: systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1205-13. doi: 10.1007/s00464-011-2051-0. Epub 2011 Dec 16.

    PubMed 22173546

  • Phillips MS, Marks JM, Roberts K, Tacchino R, Onders R, DeNoto G, Rivas H, Islam A, Soper N, Gecelter G, Rubach E, Paraskeva P, Shah S. Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. Surg Endosc. 2012 May;26(5):1296-303. doi: 10.1007/s00464-011-2028-z. Epub 2011 Nov 15.

    PubMed 22083331

  • Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26.

    PubMed 24368985

  • Gillen S, Pletzer B, Heiligensetzer A, Wolf P, Kleeff J, Feussner H, Furst A. Solo-surgical laparoscopic cholecystectomy with a joystick-guided camera device: a case-control study. Surg Endosc. 2014 Jan;28(1):164-70. doi: 10.1007/s00464-013-3142-x. Epub 2013 Aug 29.

    PubMed 23990155

  • Sasaki K, Watanabe G, Matsuda M, Hashimoto M. Original single-incision laparoscopic cholecystectomy for acute inflammation of the gallbladder. World J Gastroenterol. 2012 Mar 7;18(9):944-51. doi: 10.3748/wjg.v18.i9.944.

    PubMed 22408354

  • Chuang SH, Chen PH, Chang CM, Lin CS. Single-incision vs three-incision laparoscopic cholecystectomy for complicated and uncomplicated acute cholecystitis. World J Gastroenterol. 2013 Nov 21;19(43):7743-50. doi: 10.3748/wjg.v19.i43.7743.

    PubMed 24282363

  • Sinha R, Yadav AS. Transumbilical single incision laparoscopic cholecystectomy with conventional instruments: A continuing study. J Minim Access Surg. 2014 Oct;10(4):175-9. doi: 10.4103/0972-9941.141502.

    PubMed 25336816

  • Saber AA, El-Ghazaly TH, Dewoolkar AV, Slayton SA. Single-incision laparoscopic sleeve gastrectomy versus conventional multiport laparoscopic sleeve gastrectomy: technical considerations and strategic modifications. Surg Obes Relat Dis. 2010 Nov-Dec;6(6):658-64. doi: 10.1016/j.soard.2010.03.004. Epub 2010 Mar 19.

    PubMed 20727831

  • Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.

    PubMed 8000648

Questions about this trial

What is this clinical trial studying?

A study testing Solo surgery and operation with a camera operator in SILC in people with Cholecystectomy, Laparoscopic, run by Seoul National University Hospital.

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 4 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

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 YoungRok Choi, M.D. (+821093212477, choiyoungrok@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC) (time frame: average 2 weeks). 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 NCT03018964, which also lists 12 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 4 Apr 2019.

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