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OpenTrials
Completed

NCT Number: NCT01772745

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

Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery.

Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion criteria

  • American Society of Anesthesiologists score (ASA) more than III,
  • Patients had prior abdominal surgery,
  • Patients admitted outside working hours with acute cholecystitis,
  • Patients have choledocolithiasis,
  • pregnancy,
  • ongoing peritoneal dialysis,
  • lack of written informed consent.

Treatment and study plan

SILS Cholecystectomy

Procedure

Single incision laparoscopic cholecystectomy will be performed

TPCL cholecystectomy

Procedure

Three port laparoscopic cholecystectomy will br performed

Primary outcomes

  1. pain score

    Time frame: Postoperative first 24 hours

    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.

  2. Intraoperative complications

    Time frame: Average of 70 minutes

    Per operative complications will be recorded.

    • Bleeding
    • Gallbladder perforation
    • Bile leakage
    • Bowel perforation
    • Complications associated with increased intra-abdominal pressure

Secondary outcomes

  1. Operating time

    Time frame: Average of 70 minutes

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

Other outcomes

  1. Length of hospital stay

    Time frame: Average of 2 days

    Length of hospital stay will be recorded postoperative period.

  2. Postoperative complications

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

    Postoperative complications will be recorded postoperative follow up.

    • Bleeding
    • Bile leakage
    • Intrabdominal injury
    • Wound infection
    • Port site hernia

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 21, 2013
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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