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CompletedNCT01816568Updated Mar 22, 2013

The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy

An interventional study of SILS appendectomy and Three port laparoscopic appendectomy in Acute Appendicitis, sponsored by Maltepe University. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-22.

Sponsored by Maltepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study the investigators aimed to compare results of SILS appendectomy and three port conventional laparoscopic appendectomy prospectively.

Read the detailed description

Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic appendectomy group (n= 25) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need for conversion to an open appendectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.

02

Conditions studied

  • Acute Appendicitis

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Keywords

  • appendicitis, laparoscopy, single incision
03

In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 50 is below the median of 111 across 246 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Maltepe University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion criteria

Exclusion Criteria:

  • American Society of Anesthesiologists score (ASA) more than III,
  • Patients had prior abdominal surgery,
  • Pregnancy,
  • Ongoing peritoneal dialysis,
  • Lack of written informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Group 1

    SILS appendectomy

    Procedure: SILS appendectomy

  • Active comparator
    Group 2

    Three port laparoscopic appendectomy

    Procedure: Three port laparoscopic appendectomy

Interventions

  • ProcedureSILS appendectomy

    Single incision laparoscopic appendectomy will be performed

  • ProcedureThree port laparoscopic appendectomy

    Three port laparoscopic appendectomy will be performed

06

What researchers measure

Primary outcomes

  1. Pain score

    Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.

    Time frame: Postoperative first 24 hours

Secondary outcomes

  1. Intraoperative complications

    Per operative complications will be recorded. * Bleeding * Iatrogenic injury * Bowel perforation * Complications associated with increased intra-abdominal pressure

    Time frame: Average of 50 minutes

  2. Operating time

    The operating time will be defined as the time from the first incision to the last suture's placement.

    Time frame: Average of 50 minutes

  3. Postoperative complications

    Postoperative complications will be recorded postoperative follow up. * Bleeding * Fecal leakage * Intrabdominal injury * Wound infection * Port site hernia

    Time frame: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year

Other outcomes

  1. Length of hospital stay

    Length of hospital stay will be recorded postoperative period.

    Time frame: Average of 2 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01816568
Lead sponsor
Maltepe University
Responsible party
manuk norayk manukyan (Assoc.Prof., Maltepe University) — Principal investigator
First posted
Mar 22, 2013
Start date
Feb 2010
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Mar 22, 2013

Study contacts

Ugur Deveci, Assoc.Prof.
principal investigator · Maltepe University School of Medicine, General Surgery Department
Fatih Altintoprak, Assoc.Prof.
principal investigator · Sakarya University School of Medicine, General Surgery Department
Manuk Norayk Manukyan, Assoc.Prof.
study director · Maltepe University School of Medicine, General Surgery Department
Sertan Kapakli, Assoc.Prof.
principal investigator · Maltepe University School of Medicine, General Surgery Department
Abut Kebudi, Prof.
study chair · Maltepe University School of Medicine, General Surgery Department

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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