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"Laparoscopy - ethics"
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An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer
2012
Purpose
There is growing enthusiasm for robotic-assisted laparoscopic operations across many surgical specialities, including colorectal surgery, often not supported by robust clinical or cost-effectiveness data. A proper assessment of this new technology is required, prior to widespread recommendation or implementation.
Methods/design
The ROLARR trial is a pan-world, prospective, randomised, controlled, unblinded, superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. It will investigate differences in terms of the rate of conversion to open operation, rate of pathological involvement of circumferential resection margin, 3-year local recurrence, disease-free and overall survival rates and also operative morbidity and mortality, quality of life and cost-effectiveness. The primary outcome measure is the rate of conversion to open operation. For 80% power at the 5% (two-sided) significance level, to identify a relative 50% reduction in open conversion rate (25% to 12.5%), 336 patients will be required. The target recruitment is 400 patients overall to allow loss to follow-up. Patients will be followed up at 30 days and 6 months post-operatively and then annually until 3 years after the last patient has been randomised.
Discussion
In many centres, robotic-assisted surgery is being implemented on the basis of theoretical advantages, which have yet to be confirmed in practice. Robotic surgery is an expensive health care provision and merits robust evaluation. The ROLARR trial is a pragmatic trial aiming to provide a comprehensive evaluation of both robotic-assisted and standard laparoscopic surgery for the curative resection of rectal cancer.
Journal Article
Care and Culpability
2018
In this edition of the Annals, Mushtaq et al consider a framework which encompasses cognitive, situational as well as latent organisational factors in a systematic analysis of data acquired from a confidential reporting system for adverse surgical outcomes. Identifying factors that predict or highlight potential surgical difficulties allows surgeons to tailor interventions appropriately and ultimately better counsel patients in respect of surgical outcomes. While the proportion of fat extra-abdominally may impact on the ease of access in laparoscopic colorectal surgery, the amount of intra-abdominal fat impacted more significantly on whether or not procedures required intraoperative conversion, which in turn was linked to technical difficulties in defining the root of the mesentery and identifying surgical planes.
Journal Article
Optimal management of the morbidly obese patient SAGES appropriateness conference statement
by
Provost, D. A.
,
DeMaria, E. J.
,
Schirmer, B.
in
Aftercare
,
Anastomosis, Roux-en-Y
,
Bariatrics - methods
2004
Obesity is a growing health problem that contributes to numerous life-threatening or disabling disorders, including coronary artery disease, hypertension, type 2 diabetes mellitus, hyperlipidemia, degenerative joint disease, and obstructive sleep apnea. Significant weight reduction in the morbidly obese improves or reverses associated illness and benefits well-being. The purpose of the SAGES Appropriateness Conference was to summarize the state of the art for open and laparoscopic operations for the morbidly obese.
The English literature comparing bariatric procedures was reviewed and grouped by level of evidence by three surgeons (BS, LV, and CC). From more than 1,500 articles, all conference participants were provided with reprints and table summaries of no less than 50 selected manuscripts. Ten experts were requested to present reviews and make evidence-based arguments for and against the open and laparoscopic approaches in written format. An expert panel of six surgeons, including an ethicist and patient, commented on implications of data presented. The finalized statement was e-mailed to all participants for approval and comment.
Consensus statements were achieved on various aspects of morbid obesity, including indications for surgery, resolution of comorbid illnesses with significant weight loss, and the importance of committed bariatric program. Our panel of experts agreed, in general, to the advantages of laparoscopic approaches compared to open operations in skilled hands.
Laparoscopic Roux-en-Y gastric bypass (RYGB) affords improved short-term recovery compared to open gastric bypass. Laparoscopic adjustable banding can be performed with lower average mortality than either RYGB or any of the malabsorptive operations, and it produces variable degrees of short-term weight loss. Prospective randomized trials are needed to compare gastric bypass, malabsorptive, and restrictive procedures.
Journal Article
“First, do no harm”: monitoring outcomes during the transition from open to laparoscopic live donor nephrectomy in a Canadian centre
by
Anidjar, Maurice, MD, PhD
,
Tchervenkov, Jean, MD
,
Metrakos, Peter, MD
in
Adult
,
Benchmarking - ethics
,
Blood & organ donations
2008
Objective During the learning curve for laparoscopic live donor nephrectomy (LLDN), donor morbidity and poorer graft function may be increased. To minimize these risks, a dedicated team of laparoscopic, urologic and transplant specialists worked together to introduce the technique. This study was undertaken to validate this approach by comparing donor and recipient outcomes and studying our learning curve during the transition from open (OLDN) to LLDN. Methods We compared 59 LLDNs with 34 OLDNs performed for adult recipients. Data were collected prospectively for LLDN and retrospectively for OLDN. We compared donor outcomes and recipient graft function in the 2 groups, and we used the cumulative sum (CUSUM) method to generate learning curves; p < 0.05 was considered statistically significant. Results From the donor standpoint, the complication rate was 10% in the laparoscopic group, compared with 21% in the open group. Length of stay was shorter after LLDN (3 v. 5 d, p < 0.001). Among the recipients, there were no significant differences in the incidences of ureteral complications, delayed graft function (DGF), creatinine levels, acute rejection or patient and graft survival. When we used the incidence of DGF after OLDN as a benchmark, CUSUM analysis revealed a downward inflection point for DGF after 30 cases, consistent with an improvement in performance. Conclusion At our institution, a team approach has allowed the safe introduction of LLDN without a significant negative impact on recipient outcomes and with a reduction in donor length of stay. Using DGF as an outcome, we observed improved performance after 30 cases.
Journal Article
Impact of deep neuromuscular blockade on intraoperative NOL-guided remifentanil requirement during desflurane anesthesia in laparoscopic colorectal surgeries: A randomised controlled trial
by
Godin, Nadia
,
Oulehri, Walid
,
Morisson, Louis
in
Adult
,
Aged
,
Analgesics, Opioid - administration & dosage
2024
Evaluate the impact of deep neuromuscular blockade on intraoperative nociception Deep neuromuscular blockade has been shown to improve surgical conditions and postoperative outcomes compared to moderate neuromuscular blockade in laparoscopic surgery. Still, its impact on intraoperative nociception and opioid requirement has never been assessed.
Monocentric randomised controlled trial.
Operating room.
We included 100 ASA I to III patients who underwent colorectal laparoscopic surgery with desflurane-remifentanil anesthesia.
Patients were randomised into two groups to achieve either moderate (1–3 train of four response) or deep (1–2 post-tetanic count) neuromuscular block (NMB) with repeated boluses of rocuronium. The Nociception Level (NOL) index guided intraoperative remifentanil administration in both groups.
The primary endpoint was total intraoperative remifentanil administration per hour of surgery. Secondary endpoints included, Leiden Surgical Rating Scale (L-SRS), intra-abdominal pressure, postoperative pain scores and opioids' consumption.
Ninety-three patients were analysed. Forty-five in the deep group and 48 patients in moderate group. Intraoperative administration of remifentanil was 348 (228–472) μg.h−1 in the deep NMB group compared to 494 (392–618) μg.h−1 in the moderate NMB group (P < 0.001). Lowest L-SRS was 5 (4–5) in the deep NMB group versus 3 (2–5) (P < 0.001) in the moderate NMB group. Mean intra-abdominal pressure was 11.9 (1.3) in the deep NMB group versus 13 (1.3) (P < 0.001) in the moderate NMB group. Secondary postoperative outcomes including pain scores and analgesics administration were not significantly different.
This study shows that deep neuromuscular blockade reduces intraoperative NOL-guided administration of remifentanil in colorectal laparoscopic surgeries. It also improves surgical conditions.
The study was registered at ClinicalTrials.gov under NCT03910998.
•Deep neuromuscular block NMB reduces NOL-guided remifentanil administration by 30 % during laparoscopic colorectal surgery.•Deep neuromuscular block improves surgical satisfaction and reduces intra-abdominal pressure during laparoscopic surgery.•Postoperative outcomes including postoperative pain scores and opioids' consumption were similar between groups.
Journal Article
Robot-assisted laparoscopic surgery versus conventional laparoscopic surgery in randomized controlled trials: A systematic review and meta-analysis
2018
This review provides a comprehensive comparison of treatment outcomes between robot-assisted laparoscopic surgery (RLS) and conventional laparoscopic surgery (CLS) based on randomly-controlled trials (RCTs).
We employed RCTs to provide a systematic review that will enable the relevant community to weigh the effectiveness and efficacy of surgical robotics in controversial fields on surgical procedures both overall and on each individual surgical procedure.
A search was conducted for RCTs in PubMed, EMBASE, and Cochrane databases from 1981 to 2016. Among a total of 1,517 articles, 27 clinical reports with a mean sample size of 65 patients per report (32.7 patients who underwent RLS and 32.5 who underwent CLS), met the inclusion criteria.
CLS shows significant advantages in total operative time, net operative time, total complication rate, and operative cost (p < 0.05 in all cases), whereas the estimated blood loss was less in RLS (p < 0.05). As subgroup analyses, conversion rate on colectomy and length of hospital stay on hysterectomy statistically favors RLS (p < 0.05).
Despite higher operative cost, RLS does not result in statistically better treatment outcomes, with the exception of lower estimated blood loss. Operative time and total complication rate are significantly more favorable with CLS.
Journal Article
Comparison of mesh fixation and non-fixation in transabdominal preperitoneal (TAPP) inguinal hernia repair: a randomized control trial
by
Kamran, Hooman
,
Karoobi, Mohammadreza
,
Meshkati Yazd, Seyed Mostafa
in
Chronic illnesses
,
Endoscopy
,
Ethics
2023
IntroductionMesh fixation in inguinal hernia repair, has been a controversial subject for many years. Therefore, in this study, we evaluated and compared fixation and non-fixation of mesh in Transabdominal Preperitoneal (TAPP) Inguinal hernia repair.MethodsIn this randomized control trial, 100 patients diagnosed with unilateral inguinal hernia were included. We divided the study population into two groups of fifty. For both groups, a 15 × 13 cm Prolene(polypropylene) mesh was used for repair. In the fixation group, mesh was fixed to the abdominal wall by endoscopic tacks, while in the non-fixation group, mesh was secured at the proper place without any fixation. Postoperative outcomes were complications, recurrence, and pain intensity after 1-, 3- and 6-months.ResultsPostoperative pain intensity in the 1st month [Median of 2 and 0, (P < 0.001)], and 3rd month [Median of 0.5 and 0, (P < 0.001)], in the fixation group were significantly higher than the non-fixation group. However, 6 months after surgery, pain intensity was almost similar for both groups. In the 6th postoperative month, only one patient experienced recurrence who was in the fixation group. The rate of recurrence and urinary retention between the groups was not significant.ConclusionIt was observed that until 6 months after surgery patients who received the non-fixating method of TAPP repair experienced lower levels of pain in comparison to the fixation group while other complications did not differ between the two groups.This trail was registered at www.irct.ir with Trial Registration Number of IRCT20210224050491N1.
Journal Article
The effect of combined training program on clinical competence and professional commitment of perioperative nursing students in laparoscopic surgery: a quasi-experimental study
by
Amiri, Azadeh
,
Alizadeh, Amirali
,
Sadeghi Meymand, Shiva
in
Adult
,
Clinical Competence
,
College Science
2025
Background
With rapid advancements in medical sciences, minimally invasive surgical techniques such as laparoscopy have replaced traditional open surgeries. Enhancing the clinical competence and professional commitment of operating room nurses can empower nurses and directly impact surgical outcomes and patient safety.
Methods
A quasi-experimental pre-test-post-test control group design was employed. Ninety-four students were selected through convenience sampling and randomly allocated to two groups: an intervention group (
n
= 47) and a control group (
n
= 47). The intervention group received five sessions for training on laparoscopic surgical principles using E-learning, video demonstrations, and participatory methods. The control group received training using lectures and PowerPoint presentation. Data was collected using a demographic questionnaire, perceived perioperative competence scale- revised (PPCS-R), and the nursing professional commitment scale (NPCS), before and two weeks after the intervention.
Results
There was no significant difference in the mean scores of clinical competence and professional commitment between the two groups at baseline (
P
> 0.05). After the intervention, the mean score of clinical competence in the intervention group was significantly higher than the control group (
p
= 0.005). However, there was no significant difference in the mean score of professional commitment between the two groups after the intervention (
P
= 0.261).
Conclusion
Using a combined learning approach in laparoscopic surgery led to a significant increase in the clinical skills of nursing students, resulting in improved performance in the clinical setting. However, to further generalize the results, similar studies with larger sample sizes and in different educational settings are recommended.
Journal Article
Laparoscopic versus open surgery for perihilar cholangiocarcinoma: a multicenter propensity score analysis of short- term outcomes
by
Chen, Xuemin
,
Zhang, Yuhua
,
Yu, Guangsheng
in
Bile Duct Neoplasms - complications
,
Biomedical and Life Sciences
,
Biomedicine
2023
Background
Laparoscopic surgery (LS) has been increasingly applied in perihilar cholangiocarcinoma (pCCA). In this study, we intend to compare the short-term outcomes of LS versus open operation (OP) for pCCA in a multicentric practice in China.
Methods
This real-world analysis included 645 pCCA patients receiving LS and OP at 11 participating centers in China between January 2013 and January 2019. A comparative analysis was performed before and after propensity score matching (PSM) in LS and OP groups, and within Bismuth subgroups. Univariate and multivariate models were performed to identify significant prognostic factors of adverse surgical outcomes and postoperative length of stay (LOS).
Results
Among 645 pCCAs, 256 received LS and 389 received OP. Reduced hepaticojejunostomy (30.89%
vs
51.40%,
P
= 0.006), biliary plasty requirement (19.51%
vs
40.16%,
P
= 0.001), shorter LOS (mean 14.32
vs
17.95 d,
P
< 0.001), and lower severe complication (CD ≥ III) (12.11%
vs.
22.88%,
P
= 0.006) were observed in the LS group compared with the OP group. Major postoperative complications such as hemorrhage, biliary fistula, abdominal abscess, and hepatic insufficiency were similar between LS and OP (
P
> 0.05 for all). After PSM, the short-term outcomes of two surgical methods were similar, except for shorter LOS in LS compared with OP (mean 15.19
vs
18.48 d,
P
= 0.0007). A series subgroup analysis demonstrated that LS was safe and had advantages in shorting LOS.
Conclusion
Although the complex surgical procedures, LS generally seems to be safe and feasible for experienced surgeons.
Trial registration
NCT05402618 (date of first registration: 02/06/2022).
Journal Article