Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis

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Brief Title

Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis

Official Title

Randomized, Double-blind, Controlled Trial of Harmonic(H) Versus Monopolar Diathermy (M) for Laparoscopic Cholecystectomy (LC) for Acute Cholecystitis (AC) in Adults.

Brief Summary

      In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or
      'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis. With
      increasing experience in laparoscopic surgery, a number of centers have reported on the use
      of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically
      feasible but at the expense of a high conversion rate, which can be up to 35 per cent and
      common bile duct lesions.

      The HARMONIC SCALPEL® (H) is the leading ultrasonic cutting and coagulating surgical device,
      offering surgeons important benefits including: minimal lateral thermal tissue damage,
      minimal charring and desiccation.

      H technology reduces the need for ligatures with simultaneous cutting and coagulation:
      moreover there is not electricity to or through the patient H has a greater precision near
      vital structures and it produces minimal smoke with improved visibility in the surgical
      field.

      In retrospective series LC performed with H was demonstrated feasible and effective with
      minimal operating time and blood loss: it was reported also a low conversion rate (3.9%).

      However there are not prospective randomized controlled trials showing the advantages of H
      compared to MD (the commonly used electrical scalpel) in LC.

      Aim of this RCT is to demonstrate that H can reduce conversion rate compared to MD in LC for
      AC.
    

Detailed Description

      DESIGN

      The study project is a prospective, randomized investigation. The study will be performed in
      the Department of Emergency Surgery St Orsola-Malpighi University Hospital (Bologna, Italy),
      a large teaching institutions, with the participation of all surgeons who accept to be
      involved in.

      The patients will be divided in two groups: in the first group the patient will be submitted
      to early LC within 72 hours after the diagnosis with H while in the second group will be
      submitted to early LC within 72 hours with MD.

      HOW RANDOMIZED

      The randomization will be obtained through computer-generated schedule. The result of this
      randomization will be sealed in numbered envelopes. After cholecystitis diagnosis if the
      patient fulfils the inclusion criteria the responsible surgeon will ask the patient to
      participate to the study. If the patient agree, he/ she will sign the informed consent. After
      patient's consent the randomization will be carried out. The responsible surgeon will record
      the patient name (and number).

      All eligible patients will be recorded.

      STATISTICS

      POWER CALCULATIONS:

      Sample size has been calculated to reach a confidence level of 95% with a power of 80%.A
      sample size of 42 patients is calculated supposing that the hospital stay for LC with H the
      conversion rate can be reduced from 35% to 3%. The sample size will be 21 patients for each
      group (42 patients for the whole study).For comparison of the two groups, chi-square analysis
      and Fisher's exact test are used when appropriate for qualitative data, and the Student
      t-test (for normal variables) or the Mann Whitney U-test (for nonnormal variables) for
      quantitative data. For multivariate analysis the stepwise logistic regression is applied. A
      probability of 0.05 or less is accepted as statistically significant.

      INTERVENTION

      Preoperative data collected will include patient demographics and comorbid conditions
      (genitourinary, cardiac, pulmonary, gastrointestinal, renal, or rheumatologic) and a detailed
      history of symptom onset.

      The procedure was performed by a surgeon that had performed at least 50 LCs. On admission,
      the patients were started on cefotaxime, 2 g IV every 12h, which was continued
      postoperatively according to NNISS score.

      The standard four-trocar operative technique is used for LC for acute cholecystitis.

      When the gallbladder is distended it will be first aspirated. To allow a good hold on the
      gallbladder larger graspers will be inserted through a 5 mm right lower port. The cystic
      artery and duct are clip-ligated in the MD group whereas in the H group cystic artery and
      duct are closed by H. In the H group the surgeon will use only H, whereas in the MD group the
      surgeon will use only MD. The gallbladder and intraperitoneal "dropped" stones are collected
      in an endoscopic bag and extracted through the umbilical cannula site, which can be extended.
      A closed system suction drain is left. Fascial closure is attempted only at the umbilical
      cannula site. The skin at all the cannula sites are closed with staples. Conversion to
      laparotomy will be decided by the operating surgeon and each conversion will be motivated.

      Data Collection Patients' data sheets are generated containing demographic data and
      preoperative, operative, and postoperative information.

      Pre-operative notes concern the history of gallbladder stones, the presence of associated
      diseases (cardiac, hypertension, diabetes, malignancy), duration of gallbladder complaints
      (as an indication for the onset of the disease), finding of a palpable gallbladder,
      temperature, and laboratory results of WBC count, serum bilirubin, gamma GT, PCR, IL-6 and
      alkaline phosphatase.

      Ultrasound findings are also reported. Operative data of concern are macroscopic findings (of
      acute cholecystitis, gangrenous cholecystitis, hydrops, and empyema of the gallbladder), the
      presence of small stones (< 1 cm diameter) or large bile stones (> 1 cm diameter),
      information regarding perforation of the gallbladder and intraperitoneally "lost" stones,
      reasons for con¬version, and duration of surgery. Postoperative notes of interest included
      the use of nasogastric tubes and drains, the amount of analgesics used, (evaluation of pain
      with VAS score), complications, and length of hospital stay.

      Complications are classified as surgical infections (wound infection, subphrenic or
      subhepatic abscess); noninfectious surgi¬cal problems (e.g., bile duct injury, hemorrhage);
      remote infec¬tions (urinary or respiratory); and miscellaneous problems (e.g., atelectasis,
      deep vein thrombosis, AMI, CVA, etc). The collected information are entered into a database
      as either continuous or categorical variables for statistical analysis. Following the
      operative procedure, a normal sterile dressing will be applied to cover the abdomen.

      A second surgical team, aware of the operative findings but not the surgical dissection
      instrument, then will assume the care of the patient. Postoperative care and ability to be
      discharged from the hospital will be determined by the second surgical team. The primary
      operative team will be in every moment available for emergent consultation.

      Patient discharge will be base on good medical practice criteria: 1) apyrexia 2) absence of
      diseases requiring hospitalisation 3) return of bowel function 4) patient's compliance.

        -  IS THERE A PLACEBO? No

        -  INFORMED CONSENT TO BE SOUGHT? Yes (see: Case Report Form)

        -  INFORMED CONSENT FORM OR INFORMATION SHEET? Yes (see: Case Report Form).

      In the informed consent form, patients will receive all the information about the study
      protocol, the confidential nature of personal data and will fill up a questionnaire before
      signing or refuse.

      There will be not inconveniences caused to the patients. No incentives are planned for the
      patients regarding the operation or the follow-up.

      All the medical informations obtained from the patients will be kept confidentially among the
      research scientists conducting the study.

      The patients will be free to withdraw from the study, whenever they want without any
      obligation.

      STOPPING RULES

      In case of newly discovered statistically significant advantages in one group.

      PRIMARY ENDPOINTS

      The aim of the study is to demonstrate that H can reduce conversion rate compared to MD in LC
      for AC but also differences in terms of morbidity, mortality, operation time, hospital stay,
      postoperative pain, return to normal activity will be evaluated.

      The primary endpoints of our study will be:

        -  To evaluate the conversion rate

        -  To evaluate morbidity, mortality, operation time

        -  To evaluate hospital stay, postoperative pain, return to normal activity

      The onset of any other complications will be recorded intraoperatively, postoperatively, at
      discharge, at 7-days, 1-month and 6-months.

        -  PLANNED SUBGROUP ANALYSES? No.

        -  SIDE EFFECTS QUANTIFICATION? Yes There are not different side effects

        -  IS THERE AN ANALYSIS PLAN? Yes All the above mentioned data will be recorded in the Case
           Report Form (annexed to this proposal) and later stored in computer database. At the end
           of the study the final statistical examination will be carried out.

        -  ARE THERE PLANS FOR INTERIM ANALYSIS? Yes An interim statistical examination of the data
           will be done every 3 months during the period of patients' inclusion in the study. Then
           at the end of every completed follow-up period (1-month, 6-months).

        -  ARE THERE AN INDEPENDENT DATA-MONITORING COMITTEE? No

      TYPE OF ANALYSIS

      The statistical analysis will be carried out using Epi Info 2000, Version 1.1 software
      package (Dean AG, Arner TG, Sangam S, Sunki GG, Friedman R, Lantinga M, Zubieta JC, Sullivan
      KM, Smith DC. Epi Info 2000, a database and statistics program for public health
      professionals for use on Windows 95, 98, NT, and 2000 computers; Centers for Disease Control
      and Prevention, Atlanta, Georgia, USA, 2000).

      INDEMNITIES SPECIFIED

      No incentives are planned for the patients regarding the operation or the follow-up.

      FINISHING DATE

      The study will take approximately 6 months - 1 year for the inclusion period. According to
      the number of AC managed monthly, the duration of the inclusion period can be approximately
      of 1 year to reach the number of about 42 enrolled patients.

      REPORTING DATE

      An interim report is planned at the end of any completed follow-up period.

        -  IS THE STUDY CLINICALLY NECESSARY? Yes

      AC is a common disease. Any improvement in this field will benefit many patients reducing
      morbidity, mortality, conversion rate, operation time, hospital stay, postoperative pain,
      return to normal activity and aesthetic result. All our patients will be informed about the
      study and an informed consent will be obtained. There will not be inconveniences caused to
      the patients. All the medical informations obtained from the patients will be kept
      confidentially among the research scientists conducting the study. The patients will be free
      to withdrawn from the study, whenever they want without any obligation.
    


Study Type

Interventional


Primary Outcome

conversion rate


Condition

Cholecystitis

Intervention

early LC within 72 hours after the diagnosis with H (Harmonic)

Study Arms / Comparison Groups

 H
Description:  early LC within 72 hours after the diagnosis with H (Harmonic)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

42

Start Date

September 2008

Completion Date

December 2010

Primary Completion Date

November 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients (>18 years)

          -  Clinical (pain, fever > 37.5 °C, WBC > 10.000 / microL), and ultrasound evidence of
             cholecystitis

          -  ASA I-III patients

          -  Informed consent

          -  Less than 72h from the onset

        Exclusion Criteria:

          -  Informed consent refusal

          -  Choledocholithiasis

          -  Generalized peritonitis

          -  Previous abdominal surgical procedures

          -  Patients with an intra-operative findings of different pathology will be excluded from
             the study

          -  Apache II score > 10
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Fausto Catena, M.D. PhD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00746850

Organization ID

HAC Trial



Study Sponsor

University of Bologna


Study Sponsor

Fausto Catena, M.D. PhD, Study Director, S.Orsola-Malpighi University Hospital - University of Bologna


Verification Date

September 2008