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Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study.

ABSTRACT: BACKGROUND:While 3D laparoscopy increases surgical performance under laboratory conditions, it is unclear whether it improves outcomes in real clinical scenarios. The aim of this trial was to determine whether the 3D laparoscopy can enhance surgical efficacy in laparoscopic cholecystectomy (LCC). METHOD:This prospective randomized controlled study was conducted between February 2015 and April 2017 in a day case unit of an academic teaching hospital. Patients scheduled for elective LCC were assessed for eligibility. The exclusion criteria were: (1) planned secondary operation in addition to LCC, (2) predicted to be high-risk for conversion, and (3) surgeons with less than five previous 3D laparoscopic procedures. Patients were operated on by 12 residents and 3 attendings. The primary endpoint was operation time. All surgeons were tested for stereoaquity (Randot® stereotest). The study was registered in ClinicalTrials.gov (NCT02357589). RESULTS:A total of 210 patients were randomized; 105 to 3D laparoscopy and 104 to 2D laparoscopy. Median operation time as similar in the 3D and 2D laparoscopy groups (49 min vs. 48 min, p?=?0.703). Operation times were similar in subgroup analyses for surgeon's sex (male vs. female), surgeon's status (resident vs. attending), surgeon's stereovision (stereopsis 10 vs. less than 10), surgeon's experience (performed 200 LCCs or below versus over 200 LCCs), or patient's BMI (??25 vs. 25-30 vs. >?30). No differences in intra- or postoperative complications were noted between the 3D and 2D groups. CONCLUSION:3D laparoscopy did not show any advantages over 2D laparoscopy in LCC.

SUBMITTER: Koppatz H

PROVIDER: S-EPMC6795621 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study.

Koppatz Hanna H Harju Jukka J Sirén Jukka J Mentula Panu P Scheinin Tom T Sallinen Ville V

Surgical endoscopy 20190201 11

<h4>Background</h4>While 3D laparoscopy increases surgical performance under laboratory conditions, it is unclear whether it improves outcomes in real clinical scenarios. The aim of this trial was to determine whether the 3D laparoscopy can enhance surgical efficacy in laparoscopic cholecystectomy (LCC).<h4>Method</h4>This prospective randomized controlled study was conducted between February 2015 and April 2017 in a day case unit of an academic teaching hospital. Patients scheduled for elective ...[more]

PMID: 30710315

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Project description:Hysterectomy is one of the most common surgical procedures for women of reproductive age. Laparoscopy was introduced in the 1990es and is today one of the recommended routes of surgery. A recent observational study showed that operative time for hysterectomy was significantly lower for 3-dimensional compared to conventional laparoscopy. Complication rates were similar for the two groups. No other observational studies or randomized clinical trials have compared 3-dimensional to conventional laparoscopy in patients undergoing total hysterectomy for benign disease. The objective of the study is to determine if 3D laparoscopy gives better quality of life, less postoperative pain, less per- and postoperative complications, shorter operative time, or a shorter stay in hospital and a faster return to work or normal life, compared to conventional laparoscopy for benign hysterectomy.The design is a randomised multicentre clinical trial. Participants will be 400 women referred for laparoscopic hysterectomy for benign indications. Patients will be randomized to 3-dimensional or conventional laparoscopic hysterectomy. Operative procedures will follow the same principles and the same standard whether the surgeon's vision is 3-dimensional or conventional laparoscopy. Primary outcomes will be the impact of surgery on quality of life, assessed by the SF 36 questionnaire, and postoperative pain, assessed by a Visual Analogue scale for pain measurement. With a standard deviation of 12 points on SF 36 questionnaire, a risk of type I error of 3.3% and a risk of type II error of 10% a sample size of 190 patients in each arm of the trial is needed. Secondarily, we will investigate operative time, time to return to work, length of hospital stay, and - and postoperative complications.This trial will be the first randomized clinical trial investigating the potential clinical benefits and harms of 3-dimensional compared to conventional laparoscopy. The results may provide more evidence regarding the future place of 3-dimensional laparoscopy in the range of endoscopic approaches for benign hysterectomy.This study is registered at ClinicalTrial.gov: NCT02610985 November 16th 2015. November 2015. The regional Ethical committee approved it on the 12. November 2015, approval number: SJ-498. Data handling was approved by the Danish Data Protection Agency: REG-109-2015 on the 13. November 2015.

Project description:ObjectiveAnatomical segmentectomy has been proven to be a viable surgical treatment for small-size peripheral lung nodules. Three-dimensional (3D) reconstruction computed tomography (CT) has been proposed as an effective approach to overcome the challenges of encountering pulmonary anatomical variations when performing segmentectomy. Therefore, to further investigate the usefulness of preoperative 3D reconstruction CT in segmentectomy, we will conduct this prospective, multicenter randomized controlled DRIVATS study to compare the use of 3D reconstruction CT with standard chest CT in video-assisted segmentectomy (ClinicalTrials.gov ID: NCT04004494).MethodsThis study began in July 2019 and a total of 190 patients will be accrued from three clinical centers within 4 years. The main inclusion criteria are patients with a single peripheral nodule 0.8-2 cm with at least one of the following requirements: (i) histology of adenocarcinoma in situ; (ii) nodule has ≥50% ground-glass appearance on CT; (iii) radiologic surveillance confirms a long doubling time (≥400 days). Surgical procedures include segmental resection of the lesion and mediastinal lymph node sampling (subsegmental resection or combined subsegmental resection will not be included in this study). The primary endpoint is operative time. The secondary endpoints include incidence of change of surgical plan, intraoperative blood loss, conversion rate, operative accident event, incidence of postoperative complications, postoperative hospital stay, length of hospitalization, duration of chest tube placement, postoperative 30-day mortality, dissection of lymph nodes, overall survival, disease-free survival, preoperative lung function, and postoperative lung function.DiscussionThis multicenter DRIVATS study aims to verify the usefulness of preoperative 3D reconstruction CT compared with standard chest CT in segmentectomy. If successfully completed, this multicenter prospective study will provide a higher level of evidence for the use of 3D reconstruction CT in segmentectomy.

Dataset Information

Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study.

Publications

Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study.

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