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Is 3D faster and safer than 4K laparoscopic cholecystectomy? A randomised-controlled trial.

ABSTRACT: BACKGROUND:Laparoscopic surgery has well-established benefits for patients; however, laparoscopic procedures have a long and difficult learning curve, in large part due to the lack of stereoscopic depth perception. Developments in high-definition and stereoscopic imaging have attempted to overcome this. Three-dimensional high-definition (3D HD) systems are thought to improve operating times compared to two-dimensional high-definition systems. However their performance against new, ultra-high-definition ('4K') systems is not known. METHODS:Patients undergoing laparoscopic cholecystectomy were randomised to 3D HD or 4K laparoscopy. Operative videos were recorded, and the time from gallbladder exposure to separation from the liver (minus on table cholangiogram) was calculated. Blinded video assessment was performed to calculate intraoperative error scores. RESULTS:One hundred and twenty patients were randomised, of which 109 were analysed (3D HD n?=?54; 4K n?=?55). No reduction in operative time was detected with 3D HD compared to 4K laparoscopy (median [IQR]; 23.41 min [17.00-37.98] vs 20.90 min [17.67-33.03]; p?=?0.91); nor was there any decrease observed in error scores (60 [56-62] vs 58 [56-60]; p?=?0.27), complications or reattendance. Stone spillage occurred more frequently with 3D HD, but there were no other differences in individual error rates. Gallbladder grade and operating surgeon had significant effects on time to complete the operation. Gallbladder grade also had a significant effect on the error score. CONCLUSIONS:A 3D HD laparoscopic system did not reduce operative time or error scores during laparoscopic cholecystectomy compared with a new 4K imaging system.

SUBMITTER: Dunstan M

PROVIDER: S-EPMC7093366 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Is 3D faster and safer than 4K laparoscopic cholecystectomy? A randomised-controlled trial.

Dunstan Matt M Smith Ralph R Schwab Katie K Scala Andrea A Gatenby Piers P Whyte Martin M Rockall Tim T Jourdan Iain I

Surgical endoscopy 20190718 4

<h4>Background</h4>Laparoscopic surgery has well-established benefits for patients; however, laparoscopic procedures have a long and difficult learning curve, in large part due to the lack of stereoscopic depth perception. Developments in high-definition and stereoscopic imaging have attempted to overcome this. Three-dimensional high-definition (3D HD) systems are thought to improve operating times compared to two-dimensional high-definition systems. However their performance against new, ultra- ...[more]

PMID: 31321536

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Project description:BackgroundEmerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated.Methods/designThe SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm.DiscussionThe SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body image after SPLC.Trial registration(clinicaltrial.gov): NCT 01278472.

Project description:BackgroundRecent meta-analyses concluded that antibiotic prophylaxis is not warranted in low-risk laparoscopic cholecystectomy. However, most trials in the meta-analyses had a relatively small sample size and were statistically underpowered. In addition, many of the trials mentioned potential cost savings owing to the elimination of prophylactic antibiotics. However, no trial has statistically estimated the cost effectiveness. To evaluate the results of meta-analyses, we conducted a randomized controlled trial on the role of prophylactic antibiotics in low-risk laparoscopic cholecystectomy with an adequate sample size.MethodsFrom March 2007 to May 2013, at the Department of Surgery, Kansai Medical University, patients who were scheduled for elective laparoscopic cholecystectomy were randomly assigned to one of two arms: those who were and were not administered prophylactic antibiotics. The primary endpoint was the occurrence of postoperative infections and secondary endpoints were postoperative hospital stay and medical costs.FindingsDuring the study period, 518 patients were assigned to the Antibiotics group and 519 to the No antibiotics group. Occurrences of surgical site infections, distant infections and overall infections were significantly lower in the Antibiotics group than in the No antibiotics group (0.8 vs. 3.7%, p?=?0.001, OR: 0.205 (95%CI: 0.069 to 0.606); 0.4 vs. 3.1%, p?=?0.0004, OR: 0.122 (95%CI: 0.028 to 0.533); 1.2 vs. 6.7%; p<0.0001, OR: 0.162 (95%CI: 0.068 to 0.389), respectively). The postoperative hospital stay was significantly shorter in the Antibiotics group (mean, SD: 3.69±1.56 vs. 4.07±3.00; p?=?0.01) and the postoperative medical costs were significantly lower in the Antibiotics group (mean, SD: $766±341 vs. 832±670; p?=?0.047). Multivariable analysis showed that independent risk factors for postoperative infectious complications were no prophylactic antibiotics (p<0.0001) and age 65 or older (p?=?0.006).ConclusionsPerioperative administration of prophylactic antibiotics should be recommended in laparoscopic cholecystectomy to prevent postoperative infectious complications and to reduce medical costs.Trial registrationUMIN Clinical Trials Registry UMIN000003749.

Project description:BackgroundVision is an important and defining element of laparoscopy and significantly affects the outcome of surgery in terms of time, error, and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD) and two-dimensional (2D) ultra-high-resolution (4K) monitors. 3D HD systems offer a number of potential benefits to surgeons and patients over traditional 2D systems, including reduced operating time, blood loss, and hospital stay. However, the performance of 3D systems against the new, ultra-high definition 4K systems is barely known and highly controversial. There is a paucity of studies comparing them in clinical settings. The aim of this study is to compare 2D 4K and 3D HD perspectives in gastric bypass surgery.MethodsForty-eight patients with an indication for gastric bypass will be randomized to receive laparoscopic gastric bypass surgery using either 2D 4K or 3D HD systems. The operations will be performed by a well-coordinated team of three senior surgeons. The primary outcome is operative time. Secondary outcomes include intraoperative complications, blood loss, operator workload as assessed by the validated Surg-TLX questionnaire, and postoperative complications according to the Clavien-Dindo classification. An interim analysis is planned after enrollment of 12 participants for each group.DiscussionThis prospective, randomized trial is designed to test the hypothesis that the use of a 3D HD system will result in a significant improvement in operative time compared to a 2D 4K system in bariatric surgery. The objective is to provide clinical evidence for new laparoscopic imaging systems and to evaluate potential benefits.Trial registrationThis trial is registered at clinicaltrials.gov under the identifier NCT05895058. Registered 30 May 2023. BASEC2023-D0014 [Registry ID Swissethics, approved 3 May 2023]. SNCTP000005489 [SNCTP study register, last updated 13 July 2023].

Project description:AimsThe role of laparoscopy in rectal cancer has been questioned. 3D laparoscopic systems are suggested to aid optimal surgical performance but have not been evaluated in advanced procedures. We hypothesised that stereoscopic imaging could improve the performance of laparoscopic total mesorectal excision (TME).MethodsA multicentre developmental randomised controlled trial comparing 2D and 3D laparoscopic TME was performed (ISRCTN59485808). Trial surgeons were colorectal consultants that had completed their TME proficiency curve and underwent stereoscopic visual testing. Patients requiring elective laparoscopic TME with curative intent were centrally randomised (1:1) to 2D or 3D using Karl Storz IMAGE1 S D3-Link™ and 10-mm TIPCAM®1S 3D passive polarising laparoscopic systems. Outcomes were enacted adverse events as assessed by the observational clinical human reliability analysis technique, intraoperative data, 30-day patient outcomes, histopathological specimen assessment and surgeon cognitive load.Results88 patients were included. There were no differences in patient or tumour demographics, surgeon stereopsis, case difficulty, cognitive load, operative time, blood loss or conversion between the trial arms. 1377 intraoperative adverse events were identified (median 18 per case, IQR 14-21, range 2-49) with no differences seen between the 2D and 3D arms (18 (95% CI 17-21) vs. 17 (95% CI 16-19), p?=?0.437). 3D laparoscopy had non-significantly higher mesorectal fascial plane resections (94 vs. 77%, p?=?0.059; OR 0.23 (95% CI 0.05-1.16)) but equal lymph node yield and circumferential margin distance and involvement. 30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates were equal between the 2D and 3D arms.ConclusionFeasibility of performing multicentre 3D laparoscopic multicentre trials of specialist performed complex procedures is shown. 3D imaging did not alter the number of intraoperative adverse events; however, a potential improvement in mesorectal specimen quality was observed and should form the focus of future 3D laparoscopic TME trials.

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Is 3D faster and safer than 4K laparoscopic cholecystectomy? A randomised-controlled trial.

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Is 3D faster and safer than 4K laparoscopic cholecystectomy? A randomised-controlled trial.

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