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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by San Giovanni Addolorata Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
San Giovanni Addolorata Hospital
ClinicalTrials.gov Identifier:
NCT01339325
First received: March 30, 2011
Last updated: April 19, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Cholelithiasis
 Procedure: Cholecystectomy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparo-endoscopic Single Site Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by San Giovanni Addolorata Hospital:

Primary Outcome Measures:
  • Postoperative Quality of Life (QoL) [ Time Frame: one month ] [ Designated as safety issue: No ]
    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:
  • operative time [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    operative time is expressed in minutes from the first skin incision on the patient's abdomen to the closure of the last laparoscopic incision

  • conversion rate to standard LC [ Time Frame: day 1 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • complication rate [ Time Frame: one month ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 180
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by San Giovanni Addolorata Hospital

Additional 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
Study First Received: March 30, 2011
Last Updated: April 19, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013