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Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE (LESSCHO)

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ClinicalTrials.gov Identifier: NCT01339325
Recruitment Status : Unknown
Verified March 2011 by San Giovanni Addolorata Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2011
Last Update Posted : April 20, 2011
Sponsor:
Information provided by:
San Giovanni Addolorata Hospital

Brief Summary:
The aim of this study is to assess possible differences between the LESS approach and the standard laparoscopic approach to cholecystectomy. In particular, the Postoperative Quality of Life (QoL) will be investigated by analyzing the followings: length of hospital stay (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire. Furthermore, operative time, conversion to standard LC rate, difficulty of exposure, difficulty of dissection, and complication rate will be compared.

Condition or disease Intervention/treatment Phase
Cholelithiasis Procedure: Cholecystectomy Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparo-endoscopic Single Site Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
Study Start Date : May 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Gallstones
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: LESS cholecystectomy
Laparo-endoscopic single site cholecystectomy, the entire surface of the patient's abdomen is covered by plaster at the end of the operation. Patient does not know which kind of procedure he underwent before discharge.
Procedure: Cholecystectomy

Standard laparoscopic cholecystectomy The first cannula is inserted with an "open laparoscopy" technique. LCs are performed with either HF or US energized dissection, standard or fundus-first gallbladder dissection, closure of the artery by ligature/clip or US, closure of cystic duct by ligature/clip.

Laparo-endoscopic single site cholecystectomy

The TriPort device is inserted at the navel site through a 15 to 25 mm incision with an "open laparoscopy" technique. Two working instruments are inserted (one grasper and one energised device) through the TriPort. A further 1.8 or 3 mm instrument inserted through the larger gel valve, parallel to a 5 mm dissecting instrument, is used in some cases to enhance exposure. Gallbladder dissection is accomplished either after preparation of the cystic duct and artery or with a fundus-first technique, by means of HF electrosurgery or US shears.The cystic artery is divided between clips or by US scissors. The duct is divided between clips.

Active Comparator: Standard LAP-CHOLE
Standard laparoscopic cholecystectomy. The entire surface of the patient's abdomen is covered by plaster at the end of the operation. Patient does not know which kind of procedure he underwent before discharge.
Procedure: Cholecystectomy

Standard laparoscopic cholecystectomy The first cannula is inserted with an "open laparoscopy" technique. LCs are performed with either HF or US energized dissection, standard or fundus-first gallbladder dissection, closure of the artery by ligature/clip or US, closure of cystic duct by ligature/clip.

Laparo-endoscopic single site cholecystectomy

The TriPort device is inserted at the navel site through a 15 to 25 mm incision with an "open laparoscopy" technique. Two working instruments are inserted (one grasper and one energised device) through the TriPort. A further 1.8 or 3 mm instrument inserted through the larger gel valve, parallel to a 5 mm dissecting instrument, is used in some cases to enhance exposure. Gallbladder dissection is accomplished either after preparation of the cystic duct and artery or with a fundus-first technique, by means of HF electrosurgery or US shears.The cystic artery is divided between clips or by US scissors. The duct is divided between clips.

Active Comparator: LESS Cholecystectomy not blind
Laparo-endoscopic single site cholecystectomy. The patient is aware of the procedure he underwent.
Procedure: Cholecystectomy

Standard laparoscopic cholecystectomy The first cannula is inserted with an "open laparoscopy" technique. LCs are performed with either HF or US energized dissection, standard or fundus-first gallbladder dissection, closure of the artery by ligature/clip or US, closure of cystic duct by ligature/clip.

Laparo-endoscopic single site cholecystectomy

The TriPort device is inserted at the navel site through a 15 to 25 mm incision with an "open laparoscopy" technique. Two working instruments are inserted (one grasper and one energised device) through the TriPort. A further 1.8 or 3 mm instrument inserted through the larger gel valve, parallel to a 5 mm dissecting instrument, is used in some cases to enhance exposure. Gallbladder dissection is accomplished either after preparation of the cystic duct and artery or with a fundus-first technique, by means of HF electrosurgery or US shears.The cystic artery is divided between clips or by US scissors. The duct is divided between clips.




Primary Outcome Measures :
  1. Postoperative Quality of Life (QoL) [ Time Frame: one month ]
    Postoperative Quality of Life (QoL) will be the primary endpoint: QoL will be assessed analysing the followings: length of hospital stay (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire.


Secondary Outcome Measures :
  1. operative time [ Time Frame: day 1 ]
    operative time is expressed in minutes from the first skin incision on the patient's abdomen to the closure of the last laparoscopic incision

  2. conversion rate to standard LC [ Time Frame: day 1 ]

    Conversion rate is intended:

    for the two single access laparoscopic cholecystectomy arms as the number and percentage of procedures during which one or more laparoscopic cannulas are introduced to accomplish surgery or a laparotomy is required.

    for the standard laparoscopic cholecystectomy arm as the number and percentage of procedure during which a laparotomy is required to accomplish surgery.


  3. surgeon perception of difficulty of exposure measured with a Visual Analog Scale (VAS) with 0 to the least difficult and 5 to the most difficult [ Time Frame: day 1 ]
  4. surgeon perception of difficulty of dissection measured with a Visual Analog Scale (VAS) with 0 to the least difficult and 5 to the most difficult [ Time Frame: day 1 ]
  5. complication rate [ Time Frame: one month ]

    complications are divided into intraoperative and postoperative complications. Intraoperative complications rate is the rate of the following complications that may occur intraoperatively in all 3 study groups: bleeding, bile duct injuries, visceral injuries, gallbladder rupture.

    Postoperative complications rate is the rate of the following complications that may occur within 1 month in all 3 study groups: bleeding, intra-abdominal fluid collection, pancreatitis, bile duct injury, pain caused by missed CBD stones, infection of the skin incision/s, incisional hernia.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-75
  • BMI < 35
  • no previous upper GI or right colonic surgery with severe adhesions gallstones with absence of clinical signs of acute cholecystitis, bile duct stones or pancreatitis.
  • ASA I-III
  • Nassar grade of difficulty in performing a laparoscopic cholecystectomy I-III
  • diagnosis: cholelithiasis

Exclusion Criteria:

  • cholecystitis
  • existence of common duct stones
  • presence of biliary cancer
  • Previous abdominal surgery on organs of the supramesocolic space

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339325


Contacts
Contact: Marco Maria Lirici, FACS +39-329-6508250 marcomlirici@tiscali.it

Locations
Italy
San Giovanni Hospital Not yet recruiting
Rome, Lazio, Italy, 00184
Contact: Marco M Lirici, FACS    +39-329-6508250    marcomlirici@tiscali.it   
Principal Investigator: Marco Maria Lirici, FACS         
Sponsors and Collaborators
San Giovanni Addolorata Hospital
Investigators
Principal Investigator: Marco Maria Lirici, FACS San Giovanni Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Maria Lirici, San Giovanni Addolorata Hospital
ClinicalTrials.gov Identifier: NCT01339325     History of Changes
Other Study ID Numbers: SGAddolorataH-MLirici-14-93
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: March 2011

Keywords provided by San Giovanni Addolorata Hospital:
Laparo-endoscopic single site cholecystectomy
Quality of Life
Postoperative Pain
Cosmetics
Complication

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical