Dataset Information

The HAC trial (harmonic for acute cholecystitis): a randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis.

ABSTRACT: The HARMONIC SCALPEL (H) is an advanced ultrasonic cutting and coagulating surgical device with important clinical advantages, such as: reduced ligature demand; greater precision due to minimal lateral thermal tissue damage; minimal smoke production; absence of electric corrents running through the patient. However, there are no prospective RCTs demonstrating the advantages of H compared to the conventional monopolar diathermy (MD) during laparoscopic cholecystectomy (LC) in cases of acute cholecystitis (AC).This study was a prospective, single-center, randomized trial (Trial Registration Number: NCT00746850) designed to investigate whether the use of H can reduce the incidence of intra-operative conversion during LC in cases of AC, compared to the use of MD. Patients were divided into two groups: both groups underwent early LC, within 72 hours of diagnosis, using H and MD respectively (H = experimental/study group, MD = control group). The study was designed and conducted in accordance with the regulations of Good Clinical Practice.42 patients were randomly assigned the use of H (21 patients) or MD (21 patients) during LC. The two groups were comparable in terms of basic patient characteristics. Mean operating time in the H group was 101.3 minutes compared to 106.4 minutes in the control group (p=ns); overall blood loss was significantly lower in the H group. Conversion rate was 4.7% for the H group, which was significantly lower than the 33% conversion rate for the control group (p<0.05). Post-operative morbidity rates differed slightly: 19% and 23% in the H and control groups, respectively (p=ns). Average post-operative hospitalization lasted 5.2 days in the H group compared to 5.4 days in the control group (p=ns).The use of H appears to correlate with reduced rates of laparoscopic-open conversion. Given this evidence, H may be more suitable than MD for technically demanding cases of AC.

SUBMITTER: Catena F

PROVIDER: S-EPMC4223749 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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The HAC trial (harmonic for acute cholecystitis): a randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis.

Catena Fausto F Di Saverio Salomone S Ansaloni Luca L Coccolini Federico F Sartelli Massimo M Vallicelli Carlo C Cucchi Michele M Tarasconi Antonio A Catena Rodolfo R De' Angelis GianLuigi G Abongwa Hariscine Keng HK Lazzareschi Daniel D Pinna Antonio A

World journal of emergency surgery : WJES 20141020 1

<h4>Background</h4>The HARMONIC SCALPEL (H) is an advanced ultrasonic cutting and coagulating surgical device with important clinical advantages, such as: reduced ligature demand; greater precision due to minimal lateral thermal tissue damage; minimal smoke production; absence of electric corrents running through the patient. However, there are no prospective RCTs demonstrating the advantages of H compared to the conventional monopolar diathermy (MD) during laparoscopic cholecystectomy (LC) in c ...[more]

PMID: 25383091

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Project description:BackgroundSevere adhesions and fibrosis between the posterior wall of the gallbladder and liver bed often render total cholecystectomy after percutaneous transhepatic gallbladder drainage (PTGBD) difficult, leading to high open conversion rates. Since the publication of Tokyo Guidelines 2018 (TG18), our policy has shifted from open conversion to subtotal cholecystectomy (SC) when total laparoscopic cholecystectomy for difficult cases of cholecystitis is not feasible. Recently, SC has been frequently applied as bailout surgery for complicated cholecystitis. Nonetheless, the efficacy and validity of laparoscopic SC after PTGBD remain unclear. This study aimed to evaluate the safety and feasibility of laparoscopic SC after PTGBD for grade II or III acute cholecystitis (AC) by comparing two periods of altered surgical strategies.MethodsThis retrospective cohort study was conducted between January 2013 and December 2020. A total of 44 eligible patients with grade II or III AC were divided according to the time of cholecystitis onset into the pre-TG18 group (2013-2017, n = 17) and post-TG18 group (2018-2020, n = 27). Patients' background demographics, surgical method, surgical results, and postoperative complications were compared.ResultsThe interval between PTGBD and surgery was significantly longer in the post-TG18 group than in the pre-TG18 group (15 [interquartile range: 9-42] days vs. 8 [4-11] days; P = 0.010). The frequency of laparoscopic cholecystectomy significantly increased from 52.9% in the pre-TG18 group to 88.9% in the post-TG18 group (P = 0.007), whereas the frequency of SC was 23.5% and 40.7%, respectively, which showed no statistically significant difference (P = 0.241). However, the rate of laparoscopic SC significantly increased from 0 to 90.9% among 15 SC cases, whereas the rate of open SC significantly plummeted from 100 to 9.1% (P = 0.001). Significant differences in the operative time, amount of intraoperative bleeding, and incidence of postoperative complications (wound infection and subhepatic abscess) were not observed. Mortality, bile leakage, and bile duct injury did not occur in either group.ConclusionsFor grade II or III AC after PTGBD, aggressive adoption of SC increased the completion rate of laparoscopic surgery. Laparoscopic SC is a safe and feasible treatment option.

Project description:The laparoscopic cholecystectomy (LC) is an important approach of treating acute cholecystitis and the timing of performing this given treatment is associated with clinical outcomes. Although several meta-analyses have been done to investigate the optimal timing of implementing this treatment, the conflicting findings from these meta-analyses still confuse decision-making. And thus, we performed this systematic review to assess discordant meta-analyses and generate conclusive findings to facilitate informed decision-making in clinical context eventually. We electronically searched the PubMed, Cochrane Library, and EMBASE to include meta-analysis comparing early (within 7 days of the onset of symptoms) with delayed LC (at least 1 week after initial conservative treatment) for acute cholecystitis through August 2015. Two independent investigators completed all tasks including scanning and appraising eligibility, abstracting essential information using prespecified extraction form, assessing methodological quality using Oxford Levels of Evidence and Assessment of Multiple Systematic Reviews (AMSTAR) tool, and assessing the reporting quality using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), as well as implementing Jadad algorithm in each step for the whole process. A heterogeneity degree of ≤50% is accepted. Seven eligible meta-analyses were included eventually. Only one was Level I of evidence and remaining studies were Level II of evidence. The AMSTAR scores varied from 8 to 11 with a median of 9. The PRISMA scores varied from 19 to 26. The most heterogeneity level fell into the desired criteria. After implementing Jadad algorithm, 2 meta-analyses with more eligible RCTs were selected based on search strategies and implication of selection. The best available evidence indicated a nonsignificant difference in mortality, bile duct injury, bile leakage, overall complications, and conversion to open surgery, but a significant reduction in wound infection, hospitalization, and operation duration and improvement of the quality of life when compared early LC with delayed LC. However, number of work days lost, hospital costs, and patient satisfaction are warranted to be assessed further. With the best available evidence, we recommend early LC to be as the standard treatment option in treating acute cholecystitis.

Dataset Information

The HAC trial (harmonic for acute cholecystitis): a randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis.

Publications

The HAC trial (harmonic for acute cholecystitis): a randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis.

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