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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

Tracking Information
First Submitted Date  ICMJE March 30, 2011
First Posted Date  ICMJE April 20, 2011
Last Update Posted Date April 20, 2011
Study Start Date  ICMJE May 2011
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
  • 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
  • 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.
  • 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 ]
  • 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 ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE
Official Title  ICMJE Laparo-endoscopic Single Site Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
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.
Detailed Description

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.

Altman nomograms were used to calculate the presumed sample size of an actual RCT, arbitrarily assuming a most likely small standardized difference (0.3). With a significant criterion set at 0.05, using a two-tailed test, the number of patients per group, required to have a 90% power is ~500. Therefore, it was decided to carry on a pilot trial, enrolling 40 patients (20 each group), to assess differences in any of the end-points and tailoring the sample size of the larger multicenter RCT accordingly.

This dual-institutional prospective, randomized pilot trial was conducted during 2009 obtaining information on the power and sample size needed for a planned multicenter randomized control trial. Our results showed that Quality of life data concerning LESS cholecystectomy are somewhat controversial: cosmetics and SF36 role emotional parameter significantly improved, no differences were found in length of hospital stay, early postoperative pain (same day of surgery) was higher but no impact on need for pain-relieving medications was found. Altman nomograms were used again to calculate the presumed sample size of an actual RCT based on the differences found on our initial results. With a significant criterion set at 0.05, using a two-tailed test, the number of patients per group, required to have a 90% power in this multicenter RCT is ~180 patients.

Study design Randomization is performed preoperatively and stratification is performed intraoperatively, after visualization of the operative field. Patients are randomized to one of three groups: LESS cholecystectomy blind, standard LC, LESS cholecystectomy not blind. Patients are stratified into 3 groups: Nassar grade I, II, III, according to the grade of difficulty of cholecystectomy (Nassar score) assessed at the initial inspection of the operating field.

Patients of the first two groups do not know the treatment received until their discharge. A large drape is used to cover the abdomen after surgery, thus hiding the surgical wounds. Patients of the LESS cholecystectomy not blind group are aware of the procedure they undergo. The third arm is intended to better evaluate the influence of psychological factors on postoperative pain, cosmetics and quality of life.

All operations are performed by high-skilled laparoscopic surgeons (one each institution) with over 15-year experience in advanced laparoscopic surgery.

Difficulty (impaired) of exposure and difficulty of dissection are assessed subjectively by the operating surgeon and scored 1 to 4, being 1 "no difficulties", 4 "the most difficult" with need for conversion.

Perioperative care is similar in all patients and in all institutions. An independent physician will assess the patient postoperatively in each institution. Postoperative pain is evaluated with a visual analogue scale (VAS) from 1 to 10, with 1 being "the least" pain, 10 "the most" pain, on the day of surgery, on postoperative day 1, 2 (discharge) and at 1-month follow-up. Pain is also deduced from the assumption of pain relieving medications. Patients will receive pain medications only on demand and these will be given in incremental strength beginning with peripheral analgesics as Non-Steroidal Anti-Rheumatic agents (NSAR).

Individual satisfaction for the cosmetic result is evaluated with a visual analogue scale (VAS) from 0 to 100% with 0 being "the worse" result, 100 "the best" one. Cosmetics is also evaluated by measuring the length of umbilical incision at the end of the operation in all study groups. The incision length is measured after gallbladder removal (during standard LC the incision may be enlarged to allow the passage of thick gallbladder or bigger stones).

QoL is assessed at the time of surgery and further assessed at postoperative month 1 by the SF36 questionnaire.

Randomization Randomization is performed preparing three sets of 30 numbered, opaque, sealed envelopes, the envelops of each set containing indications for 10 LESS cholecystectomies, 10 standard LC and 10 LESS cholecystectomies not blind. One set of envelopes is kept at each involved Institution. The envelopes are opened in numeric order for each patient by an assistant not involved in the surgical operations, right before surgery. The surgeons perform a standard LC or a LESS cholecystectomy (blind or not blind) as indicated on the sheet inside the envelopes.

Data analyses Data are analysed using the software XLSTAT Version 2009.5.01 (Addinsoft). An "intent-to-treat" analysis will be performed.

Patients demographics across the treatment groups are compared by chi-square test for categorical measures, and by t-test for continuous data. Mann-Whitney U test is used to compare LoS, postoperative pain VAS, cosmetics VAS, length of skin incision, 8 parameters of SF36, operating time, difficulty of exposure, difficulty of dissection in the two arms. Chi-square test is used to compare conversion rate and administration of pain medication, which is dichotomized as yes or no, in the three arms. All variables are significant at p< 0.05. Logistic model results are reported as odds ratios, two-sided 95% confidence intervals, and p values.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholelithiasis
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Cholecystectomy
  • 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.
    Intervention: Procedure: Cholecystectomy
  • Active Comparator: LESS Cholecystectomy not blind
    Laparo-endoscopic single site cholecystectomy. The patient is aware of the procedure he underwent.
    Intervention: Procedure: Cholecystectomy
Publications * Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2011)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01339325
Other Study ID Numbers  ICMJE SGAddolorataH-MLirici-14-93
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Maria Lirici, San Giovanni Addolorata Hospital
Study Sponsor  ICMJE San Giovanni Addolorata Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marco Maria Lirici, FACS San Giovanni Hospital
PRS Account San Giovanni Addolorata Hospital
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP