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CompletedNCT02417857Updated Apr 16, 2015

Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

An interventional study of Laparoscopic Cholecystectomy (Single Incision) and Laparoscopic Cholecystectomy (Conventional) in Laparoscopic Surgical Procedures, sponsored by Ankara Mevki Military Hospital. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-16.

Sponsored by Ankara Mevki Military Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.

Read the detailed description

Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p\<0.05 was accepted as statistically significant.

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Conditions studied

  • Laparoscopic Surgical Procedures

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Keywords

  • Single İncision Laparoscopic Surgery
  • Conventional Laparoscopic Surgery
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In context

Surgical Wound

519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.

This study's enrollment of 58 is below the median of 80 across 412 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

Ankara Mevki Military Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The patients who were scheduled for elective cholecystectomy were included in the study

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • acute cholecystitis
  • ASA 3-4 (American Society of Anesthesiologists)
  • history of bile duct stone migration
  • biller pancreatitis
  • upper laparatomy
  • any ventral hernia repair
  • chronic systemic disease or
  • with allergic attitude to any agent
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Laparoscopic Cholecystectomy (SILC)

    Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)

    Procedure: Laparoscopic Cholecystectomy (Single Incision)

  • Experimental
    Laparoscopic Cholecystectomy (CLC)

    Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)

    Procedure: Laparoscopic Cholecystectomy (Conventional)

Interventions

  • ProcedureLaparoscopic Cholecystectomy (Single Incision)

    We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1

  • ProcedureLaparoscopic Cholecystectomy (Conventional)

    We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2

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What researchers measure

Primary outcomes

  1. Quality of life measure

    Time frame: We had performed the questionnaire at postoperative 6 th month

Secondary outcomes

  1. Body Image Questionnaire measure

    Time frame: We had performed the questionnaire at postoperative 6 th month

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, El Nakeeb A, Magdy A, Amin M. Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27. PubMed 23269370 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02417857
Lead sponsor
Ankara Mevki Military Hospital
Responsible party
MD. Mehmet SAYDAM (General Surgeon) (General Surgeon (M.D.), Ankara Mevki Military Hospital) — Principal investigator
First posted
Apr 16, 2015
Start date
Jan 2011
Primary completion
Mar 2013
Completion
Mar 2014
Last update
Apr 16, 2015

Study contacts

Huseyin SINAN, Prof. M.D.
study director · VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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