Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00746850
Status:
COMPLETED
Last Update Posted:
2011-10-13
First Post:
2008-09-03
Brief Title:
Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Randomized Double-blind Controlled Trial of HarmonicH Versus Monopolar Diathermy M for Laparoscopic Cholecystectomy LC for Acute Cholecystitis AC in Adults
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAC
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 39
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
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 39
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 patients 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 80A 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 studyFor comparison of the two groups chi-square analysis and Fishers 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 005 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 conversion 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 surgical problems eg bile duct injury hemorrhage remote infections urinary or respiratory and miscellaneous problems eg 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 patients 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 11 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
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 patients 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 80A 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 studyFor comparison of the two groups chi-square analysis and Fishers 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 005 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 conversion 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 surgical problems eg bile duct injury hemorrhage remote infections urinary or respiratory and miscellaneous problems eg 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 patients 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None