Low-pressure pneumoperitoneum with deep neuromuscular blockade versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: a non-inferiority randomized control trial.

BACKGROUND: Low-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB. METHODOLOGY: This was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8-10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1-2] and Group B: SPP; 12-14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported. RESULTS: Of the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable. CONCLUSION: LPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.

Comparison of inflammatory markers in low-pressure pneumoperitoneum with deep neuromuscular block versus standard pressure pneumoperitoneum among patients undergoing laparoscopic cholecystectomy for gallstone disease: a randomized control trial.

BACKGROUND: Low-pressure pneumoperitoneum (LPP) is an attempt to improve laparoscopic surgery. Lower pressure causes lesser inflammation and better hemodynamics. There is a lack of literature comparing inflammatory markers in LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB in laparoscopic cholecystectomy. METHODOLOGY: This was a single institutional prospective randomized control trial. Participants included all patients undergoing laparoscopic cholecystectomy for symptomatic gall stone disease. Participants were divided into 2 groups group A and B. Group A-Low-pressure group in which pneumoperitoneum pressure was kept low (8-10 mmHg) with deep Neuromuscular blockade (NMB) and Group B-Normal pressure group (12-14 mmHg) with moderate NMB. A convenience sample size of 80 with 40 in each group was selected. Lab investigations like CBC, LFT, RFT and serum IL-1, IL-6, IL-17, TNF alpha levels were measured at base line and 24 h after surgery and compared using appropriate statistical tests. Other parameters like length of hospital stay, post-operative pain score, conversion rate (low-pressure to standard pressure), and complications were also compared. RESULTS: Eighty participants were analysed with 40 in each group. Baseline characteristics and investigations were statistically similar. Difference (post-operative-pre-operative) of inflammatory markers were compared between both groups. Numerically there was a slightly higher rise in most of the inflammatory markers (TLC, ESR, CRP, IL-6, TNFα) in Group B compared to Group A but not statistically significant. Albumin showed significant fall (p < 0.001) in Group B compared to Group A. Post-operative pain was also significantly less (p < 0.001) in Group A compared to Group B at 6 h and 24 h. There were no differences in length of hospital stay and incidence of complications. There was no conversion from low-pressure to standard pressure. CONCLUSION: Laparoscopic cholecystectomy performed under low-pressure pneumoperitoneum with deep NMB may have lesser inflammation and lesser post-operative pain compared to standard pressure pneumoperitoneum with moderate NMB. Future studies with larger sample size need to be designed to support these findings.

Comparison of three-dimensional (3D) endovision system versus ultra-high-definition 4K endovision system in minimally invasive surgical procedures: a randomized-open label pilot study.

BACKGROUND: Experimental work comparing 3-Dimensional (3D) and 4K ultra-high-definition endovision system (4K) indicates that the latter with double the resolution of standard 2D high-definition systems may provide additional visual cues to compensate for the lack of stereoscopic vision. There is paucity of studies comparing 3D and 4K system in clinical settings. This randomized study compares 3D and 4K systems in three laparoscopic procedures of increasing complexity. METHODS: 139 patients undergoing laparoscopic cholecystectomy (60 patients), transabdominal preperitoneal (TAPP) repair (49 patients) and laparoscopic Heller's cardiomyotomy with anti- reflux procedure (30 patients) between May 2018 and February 2020 were randomized to undergo surgery using either 3D or 4K systems. Primary objective was to measure total operative time. Secondary objectives were to compare workload perceived by surgeons using SURG-TLX and surgeon satisfaction score. Timings of key surgical steps and peri-operative course of the patients was also recorded. Data were analyzed using Stata Corp. 2015. RESULTS: Patients undergoing surgery with 3D and 4K systems were comparable in their clinical and demographic profiles. The mean total operative time in 3D and 4K groups was comparable in cholecystectomy (52.7 vs 56.2, p = 0.50), TAPP (63.8 vs 69.6, p = 0.25) and Heller's cardiomyotomy (124.7 vs 143.3, p = 0.14) with faster hiatal dissection in 3D group (8 min, p = 0.02). Operative time was better in patients undergoing Heller's myotomy with Angle of His accentuation with 3D by 28 min (p = 0.03). Total workload was similar in 3D and 4K groups in all the procedures but mental & physical demand was lower in 3D group in Heller's cardiomyotomy (p = 0.03, p = 0.01), Surgeon satisfaction score was comparable in all three procedures. CONCLUSION: Overall, 3D HD and 4K systems are comparable in performing laparoscopic cholecystectomy, TAPP and Heller's Cardiomyotomy. Hiatal dissection time, mental and physical task load was better with 3D in Heller's Cardiomyotomy.

Development and use of low-fidelity, low-cost, animal tissue-based simulators for surgical training during the Covid-19 pandemic.

Background The Covid-19 pandemic severely affected surgical training as the number of surgeries being done was reduced to a bare minimum. Teaching and training of clinical skills on a simulator are desirable as they may have an even larger role during the Covid-19 pandemic. Commercially available simulators with optimum fidelity are costly and may be difficult to sustain because of their recurring cost. The development of low-cost simulators with optimum fidelity is the need of the hour. Methods We developed animal tissue-based simulators for imparting skills training to surgical residents on some basic and advanced general surgical procedures. Porcine tissue and locally available materials were used to prepare these models. The models were pilot-tested. Standard operating procedures were developed for each skill that was shared with the participants well before the 'hands-on' exercise. An online pre-test was conducted. The training was then imparted on these models under faculty guidance adhering to Covid-19-appropriate behaviour. This was followed by a post-test and participant feedback. The entire exercise was paperless. Results Sixty residents were trained in 10 sessions. Most of the participants were men (44; 73%). The mean pre-test and post-test scores were 40.92 (standard deviation [SD] 6.27) and 42.67, respectively (SD 4.06). Paired sample t-test suggested a significant improvement in the post-test score (p<0.001). The activity and the models were well appreciated by the residents. Conclusion The animal tissue-based indigenous models are easy to prepare, cost-effective and provide optimum fidelity for skill training of surgical residents. In addition to skill acquisition, training on such modules may alleviate the stress and anxiety of the residents associated with the loss of surgical training during a time-bound residency period.

Age adjusted Charlson comorbidity index (a-CCI) AS a tool to predict 30-day post-operative outcome in general surgery patients.

INTRODUCTION: Age adjusted Charlson comorbidity index (a-CCI) is an established scoring system to predict long-term mortality. However, its role in predicting 30-day post-operative outcome in general surgery patients is not well elucidated. METHODS: This was a prospective observational study. Consecutive patients operated under general anaesthesia between January 2019 and December 2020 were enrolled. Their a-CCI was calculated and stratified as Grade 0 comorbidities (a-CCI score = 0), Grade A comorbidities (a-CCI score = 1 and 2) and Grade B comorbidities (a-CCI score ≥ 3). Post-operative complications were graded according to Clavien Dindo (CD) grading system and classified as minor complications (CD Grades I and II), major complications (CD Grades III-IV) and mortality (CD Grade V). Binary logistic regression and multi-nominal logistic regression analysis were done and relative risk ratios were calculated. RESULT: A total of 925 patients were enrolled. The mean age was 42.75 (14-85 ± 10) years. 31% of our patients had complications within 30 days of surgery which included mortality in 2.7%. Compared with patients with Grade 0 comorbidities, the odds of getting complications is 1.2 times more in patients with Grade A comorbidities and 1.84 times more in patients with Grade B comorbidities (P = 0.205, 0.001 respectively). In comparison to patients with Grade 0 co-morbidities, risk of mortality is 3 and 17.86 times more in patients with Grade A and Grade B comorbidities (P = 0.121 and < 0.001 respectively). CONCLUSION: a-CCI has clinical relevance in general surgical patients and can predict early post-operative outcome. It should be a part of our armamentarium for pre-operative assessment of surgical patients.

Impact of clinical parameters and vascular haemodynamics on arterio-venous fistula maturation in patients with end stage renal disease: A prospective study on Indian patients.

BACKGROUND: About 18%-65% of Arterio-Venous fistula (AVF) made to facilitate haemodialysis in end stage renal disease patient fail to mature. This study was designed to evaluate the impact of clinical parameters and vascular haemodynamics on maturation of AVF on Indian patients. MATERIAL AND METHODS: This was a prospective observational study. Eligible patients' clinical profiles and vascular haemodynamics by Doppler ultrasonography were noted. All patients underwent radio-cephalic AVF on the non-dominant arm under local anaesthesia. Clinical definition was used to assess success rate of AVFs which is defined as successful six settings of satisfactory dialysis. Data were analysed using Stata/12.0 software. Independent t-test, chi-square test, logistic regression analysis and multivariate analysis were used. The p-value of <0.05 was considered significant. RESULTS: A total of 205 patients were enrolled and analysed. Among clinical factors, age, sex, serum creatinine, hypertension had no significant association with failure (p = 0.5, 0.08, 0.76 and 0.74). Patient's BMI and presence of diabetes had significant impact on outcome (p < 0.001 and 0.02 respectively). Among vascular haemodynamics, radial vein diameter of >2.5 mm and radial artery flow rate >40 ml/min had no significant association with failure (p = 0.12 and 0.28). Diameter of radial artery (>2 mm) and intra-operatively immediate thrill were independent predictor of success (p = 0.002 and <0.001). CONCLUSION: In the present study rate of fistula, maturation was 73.2% without any post-operative radiological intervention. Radial artery diameter >2 mm and presence of immediate thrill post-operatively were significantly associated with successful cannulation.

Thoracolaparoscopic repair of diaphragmatic hernias.

Complex long-standing diaphragmatic hernia presenting in adults is often managed through an open approach. Minimal invasive approach by either laparoscopy or thoracoscopy is limited by its ability to tackle these complex hernias with large defects and thoraco-mediastinal adhesions. Thus, standard laparoscopic or thoracoscopic approach is associated with high conversion to open approach. We herein describe a novel combined thoraco-laparoscopic approach to repair complex diaphragmatic hernias in a series of three adults.

Persistent scrotal swelling after laparoscopic inguinal hernia repair: "Omentaloma of the scrotum".

Complete removal of all the contents of a hernial sac is crucial in laparoscopic inguinal hernia repair. We report a case who underwent transabdominal preperitoneal repair for a complete, irreducible inguinal hernia. He had persistent scrotal swelling and new onset scrotal pain post-surgery. Ultrasonography of the scrotum revealed a well-defined hypoechoic scrotal lesion. A magnetic resonance imaging revealed a fat-containing mass lesion, hypointense on T2 fat-saturated image. He underwent exploration of the scrotum and a well-encapsulated mass was excised. The histopathological evaluation revealed a well-encapsulated structure comprising of lobules of fibroadipose tissue with foci of chronic inflammation and foamy histiocytes likely retained omentum from previous surgery. His scrotal pain disappeared post-excision. A missed retained omentum in the hernial sac causes considerable anxiety to patients and diagnostic and therapeutic dilemmas for the treating surgeon. We coined the term "omentaloma of the scrotum" for such a lesion.

Is Interleukin 10 (IL10) Expression in Breast Cancer a Marker of Poor Prognosis?

Interleukin 10 (IL10) is a poor prognostic marker in several cancers. Its role in breast cancer is not well elucidated. The present study is designed to see the expression of IL10 in breast cancer tissue and to evaluate its correlation with the established markers of prognosis. Sixty female patients who underwent surgery for breast cancer were enrolled for the study. Immediately after surgery, 2-5 g of tumour tissue and similar volume of peritumoural normal breast tissue were collected for IL10 assay. IL10 expression was assayed by immunohistochemistry. IL10 expressing tumours and IL10 non expressing tumours were compared. Chi square/Fisher exact test and student's t test were used to compare the data. p- valueless than 0.05 was considered as statistically significant. Thirty six patients (60 %) of carcinoma breast showed IL 10 expression in tumour tissue as compared to no IL 10 expression in any peritumouralnormal breast tissue (p < 0.01). IL10 expression had statistically significant correlation with locally advanced disease, tumour grade, HER2 + ve tumours and ER-ve, PR-ve, HER2 + ve breast cancer subtypes (p = 0.001, 0.001, 0.001 and 0.01 respectively). No correlation could be found with patient's age, tumour size, tumour histology and ER and PR status. Correlation of IL10 expressing tumours with several established poor prognostic markers of breast cancer may indicate the possible association of IL10 expression with poor prognosis. Large studies with long term follow up are needed to substantiate the association of IL10 with poor prognosis.