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A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy

Primary Purpose

Cholelithiasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single Incision Laparoscopic Cholecystectomy (SILC)
Four Ports Laparoscopic Cholecystectomy (4PLC)
Sponsored by
Consorci Sanitari Integral
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age higher than 18 and lower than 80
  • American Society of Anesthesiologists class (ASA) I-II,
  • absence of any previous anesthetic complication,
  • accompaniment by a responsible adult during 24 hours,
  • symptomatic gallstones candidate to cholecystectomy
  • and a signed informed consent.

Exclusion Criteria:

  • a Body Mass Index (BMI) higher than 35,
  • any laparoscopic contraindication,
  • acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
  • anti-inflammatory allergy
  • psychiatric history that could hinder ambulatory procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Single Incision Cholesystectomy (SILC)

    Four Ports Cholecystectomy (4PCL)

    Arm Description

    Single Incision Laparoscopic Cholecystectomy (SILC): The umbilicus is grasped and a 2 cm vertical skin and fascial incision is performed. A multiport (TriPort®) is inserted under direct vision. Principles of cholecystectomy are the same as traditional laparoscopic cholecystectomy.

    Four Ports Conventional laparoscopic cholecystectomy (4PCL): A 10mm supraumbilical incision is made and the pneumoperitoneum insufflated through a Veress needle. 4 ports are introduced: 2 of 10mm in supraumbilical and left flank and 2 of 5mm in epigastric and right flank.

    Outcomes

    Primary Outcome Measures

    evolution of postoperative pain

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2014
    Last Updated
    February 24, 2015
    Sponsor
    Consorci Sanitari Integral
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02375529
    Brief Title
    A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
    Official Title
    Estudio Prospectivo Aleatorizado de la colecistectomía laparoscópica Por Puerto único vs colecistectomía laparoscópica Por Cuatro Puertos en Pacientes Con Colelitiasis sintomática y régimen de cirugía Sin Ingreso.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Consorci Sanitari Integral

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery. Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholelithiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Incision Cholesystectomy (SILC)
    Arm Type
    Experimental
    Arm Description
    Single Incision Laparoscopic Cholecystectomy (SILC): The umbilicus is grasped and a 2 cm vertical skin and fascial incision is performed. A multiport (TriPort®) is inserted under direct vision. Principles of cholecystectomy are the same as traditional laparoscopic cholecystectomy.
    Arm Title
    Four Ports Cholecystectomy (4PCL)
    Arm Type
    Active Comparator
    Arm Description
    Four Ports Conventional laparoscopic cholecystectomy (4PCL): A 10mm supraumbilical incision is made and the pneumoperitoneum insufflated through a Veress needle. 4 ports are introduced: 2 of 10mm in supraumbilical and left flank and 2 of 5mm in epigastric and right flank.
    Intervention Type
    Procedure
    Intervention Name(s)
    Single Incision Laparoscopic Cholecystectomy (SILC)
    Intervention Description
    A 2.5-cm incision is made through the everted umbilicus down to the midline fascia, and through the fascia and the peritoneum. The multichannel port (Olympus) is introduced. Carbon dioxide is insufflated (12 mmHg) and a 30 degree 10-mm laparoscope is introduced. The operating table is put in the reverse Trendelenburg position (20 degrees), left side down. A pre-curved grasper and the monopolar electrocautery are introduced through the other 2 ports of the trocar and the dissection of the gallbladder starts in a retrograde manner. The triangle of Calot is exposed, the cystic duct and artery are separately dissected and ligated with 5 mm clips. The monopolar electrocautery is used to remove the gallbladder from the liver bed. The gallbladder is removed along with the port system from the abdominal cavity. The fascia at the port site is closed and the umbilicus is inverted.
    Intervention Type
    Procedure
    Intervention Name(s)
    Four Ports Laparoscopic Cholecystectomy (4PLC)
    Intervention Description
    An 11-mm periumbilical port, a 10-mm left upper quadrant port , 5mm subxyphoid port, and 5-mm right lower quadrant port were used in 4-port LC. We adopted the single surgeon technique in the 4-port LC using 30-degree operating telescopes that was inserted into the umbilical port. Retraction of the gallbladder was done by the long grasping forceps through the 5-mm right lower quadrant port, whereas dissection was accomplished through the 10-mm left upper quadrant port. The cystic duct and cystic artery were clipped by a 5-mm multiple clip applicator. The gallbladder was retrieved through the umbilical port after the position of the operating telescope was changed. Nontransparent surgical adhesive tape was applied to the standard 4-port sites at the end of the operation .
    Primary Outcome Measure Information:
    Title
    evolution of postoperative pain
    Time Frame
    2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age higher than 18 and lower than 80 American Society of Anesthesiologists class (ASA) I-II, absence of any previous anesthetic complication, accompaniment by a responsible adult during 24 hours, symptomatic gallstones candidate to cholecystectomy and a signed informed consent. Exclusion Criteria: a Body Mass Index (BMI) higher than 35, any laparoscopic contraindication, acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy, anti-inflammatory allergy psychiatric history that could hinder ambulatory procedure

    12. IPD Sharing Statement

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    A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy

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