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.

Surgical Cholecystectomy Score (SCS) for grading the difficulty of laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy (LC) is the standard of care for symptomatic gall stone disease. A good scoring system is necessary to standardize the reporting. Our aim was to develop and validate an objective scoring system, the Surgical Cholecystectomy Score (SCS) to grade the difficulty of LC. METHODS: The study was conducted in a single surgical unit at a tertiary care hospital in two phases from January 2017 to April 2021. Retrospective data was analysed and the difficulty of each procedure was graded according to the modified Nassar's scoring system. Significant preoperative and intraoperative data obtained was given a weightage score. In phase II, these scores were validated on a prospective cohort. Each procedure was classified either as easy, moderately difficult or difficult. STATISTICAL ANALYSIS: A univariate analysis was performed on the data followed by a multivariate regression analysis. Bidirectional stepwise selection was done to select the most significant variables. The Beta /Schneeweiss scoring system was used to generate a rounded risk score. RESULTS: Data of 800 patients was retrieved and graded. 10 intraoperative parameters were found to be significant. Each variable was assigned a rounded risk score. The final SCS range for intraoperative parameters was 0-15. The scoring system was validated on a cohort of 249 LC. In the final scoring, cut off SCS of > 8 was found to correlate with difficult procedures. Score of < 2 was equivalent to easy LC. A score between 2 and 8 indicated moderate difficulty. The area under ROC curve was 0.98 and 0.92 for the intraoperative score indicating that the score was an excellent measure of the difficulty level of LCs. CONCLUSION: The scoring system developed in this study has shown an excellent correlation with the difficulty of LC. It needs to be validated in different cohorts and across multiple centers further.

Laparoscopic ultrasonography along with staging laparoscopy as a tool for staging in patients with hepatopancreaticobiliary malignancy - A prospective cohort study from a tertiary care centre.

INTRODUCTION: Staging laparoscopy (SL) plays an important role in avoiding unnecessary non-therapeutic laparotomy in radiologically resectable hepatopancreaticobiliary (HPB) malignancy patients. The limitation of SL is to detect deep-seated malignancy. The addition of laparoscopic ultrasonography for identifying metastatic lesions or locally unresectable disease improves the diagnostic yield of SL. PATIENTS AND METHODS: This prospective, observational study was conducted in a single unit of the tertiary care centre between 2017 and 2019. All the patients of HPB malignancy who were radiologically resectable underwent SL and laparoscopic intraoperative ultrasonography. Metastatic disease patients were either underwent palliative bypass procedures or abandoned depending on the condition of the patient. Patients who had resectable disease underwent standard surgical procedures. RESULTS: Forty patients of HPB malignancy with potentially resectable on radiological imaging underwent SL and diagnostic ultrasonography. Out of 40, 21 patients had periampullary, 14 had carcinoma gallbladder and 5 patients had distal cholangiocarcinoma. Metastatic lesions were identified on laparoscopy in eight patients and the diagnostic yield of SL is 20%. Addition of laparoscopic ultrasonography identified one haemangioma which was false positive on laparoscopy and underwent the radical standard procedure. Four patients were unresectable so the procedure was abandoned and another three patients underwent a bypass procedure. CONCLUSION: Laparoscopic ultrasonography during SL can detect deep-seated metastatic lesions and decide the management in resectable disease.

Timing of intraoperative crystalloid infusion may decrease total volume of infusate without affecting early graft function in live related renal transplant surgery: A randomized, surgeon-blinded clinical study.

INTRODUCTION: Early graft function is crucial for successful kidney transplantation. Intravascular volume maintenance is paramount in ensuring reperfusion of transplanted kidney. This study was planned to compare whether the timing of fluid infusion can help to decrease amount of fluid given without altering early graft function during renal transplantation. MATERIALS AND METHODS: The present study included forty recipients, randomized into standard (Group-S) or targeted fluid therapy (Group-T). Group S received fluid according to conventional fasting deficit while Group T received at 1 ml/kg/h from the start of surgery till start of vascular anastomosis after which fluid infusion rate in both group was increased to maintain a central venous pressure of 13-15 mm of Hg till reperfusion. Primary outcome measured was serum creatinine level on first postoperative day while secondary outcomes were IV fluid given, perioperative hemodynamics, onset of diuresis, graft turgidity, urine output, and renal function during first 6 postoperative days. RESULTS: The study showed Group T postoperatively had early fall in serum creatinine (day 3) than S (day 6) although this difference was not statistically significant. Group T had received significantly less fluid per kg of dry weight (T-42.7 ± 9.7 ml/kg, S-61.1 ± 11.1 ml/kg, P < 0.001), had early diuresis, better graft turgidity and urine output than Group S. CONCLUSION: Targeted hydration significantly decreases the total amount of fluid infused during the intraoperative period without altering early graft function. Targeted hydration during vascular anastomosis produced stable hemodynamics and early diuresis without any side-effects pertaining to hypo or hyper-volemia.Clinical trial identifier number-CTRI/2016/07/007111.

A prospective randomized comparison of sexual function and semen analysis following laparoscopic totally extraperitoneal (TEP) and transabdominal pre-peritoneal (TAPP) inguinal hernia repair.

BACKGROUND: With standardization of laparoscopic technique of groin hernia repair, the focus of surgical outcome has shifted to lesser studied parameters like sexual function and fertility. METHODS: This prospective randomized study was conducted in a single surgical unit at a tertiary care hospital. A sample size of 144 was calculated with 72 in each group (Group 1 TEP and Group 2 TAPP). Primary outcomes measured included comparison of sexual function using BMFSI, qualitative semen analysis and ASA levels between patients undergoing TEP or TAPP repair. Semen analysis and ASA was measured pre-operatively and 3 months post-operatively. RESULTS: A total of 145 patients were randomized into two groups, TAPP (73) and TEP (72) patients. Both the groups were comparable in terms of demographic profile and hernia characteristics with majority of the patients in both the groups having unilateral inguinal hernia (89.0% in TAPP group and 79.2% in TEP group). Both the groups showed statistically significant improvement in overall sexual function score (BMFSI) at 3 months; however, there was no inter group difference. Both the groups were also comparable in terms of ASA and qualitative semen analysis. CONCLUSION: Both TEP and TAPP repair are comparable in terms of sexual function and effect on semen analysis. Laparoscopic repair improves the overall sexual functions in patients with groin hernia.

"Misra's appendicular hitch" stich - Innovative technique for simplifying endo-suturing during laparoscopic appendectomy.

Laparoscopic suture transfixation and free tie ligation are the most commonly used cost-effective technique of managing the base of the appendix during laparoscopic appendectomy in low resource settings such as India. This becomes technically cumbersome especially in the presence of the long friable appendix and for novice surgeons. We hereby describe an innovative technique of suspending the appendix using a transfacial suture to ease the placement of suture at the base of the appendix during laparoscopic appendectomy.

Surgical practice recommendations for minimal access surgeons during COVID 19 pandemic - Indian inter-society directives.

These are inter-society guidelines for performance of laparoscopic surgery during COVID-19 pandemic that has affected the way of surgical practice. The safety of healthcare workers and patients is being challenged. It is prudent that our surgical practice should adapt to this rapidly changing health environment. The guidance issued is based on global practices and national governmental directives. The Inter-Society Group urges you to be updated with the developing situation and evolving changes.

Perception of sex workers of Lucknow City, Uttar Pradesh, India towards sexually transmitted infections.

The prevention, control, and management of sexually transmitted infections/reproductive tract infection (STI/RTI) are well-recognized cost-effective strategies for controlling the spread of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). A cross-sectional descriptive study was done over a period of 1 year to assess the prevalence of STI, knowledge level about STI, and the STI-HIV link among the female sex workers (FSWs) of Lucknow city, Uttar Pradesh, India along with their biosocial characteristics. Most of the FSWs were illiterate, married, Hindus, and belonged to general category. The prevalence rates of STI among street-based and home-based FSWs were 50.6% and 29.8%, respectively. Knowledge about the role of condom in prevention of STI and the STI-HIV link was significantly less among home-based FSWs than those who are street-based. There is a great lack in the awareness among FSWs regarding STI and their prevention. Behavior change communication (BCC) and advocacy strategy were developed, especially for the home-based group, to strengthen their knowledge regarding the STI-HIV link.

Use of Critical View of Safety and Proctored Preceptorship in Preventing Bile Duct Injury During Laparoscopic Cholecystectomy-Experience of 3726 Cases From a Tertiary Care Teaching Institute.

INTRODUCTION: Bile duct injury (BDI) continues to occur despite technological advances and improvements in surgical training over the past 2 decades. This study was conducted to audit our data on laparoscopic cholecystectomies performed over the past 2 decades to determine the role of Critical View of Safety (CVS) and proctored preceptorship in preventing BDI and postoperative complications. MATERIALS AND METHODS: All patients undergoing elective laparoscopic cholecystectomy were analyzed retrospectively. The data were obtained from a prospectively maintained database from January 2004 to December 2019. Proctored preceptorship was used in all cases. Intraoperative details included the number of patients where CVS was defined, number of BDI and conversions. Postoperative outcomes, including hospital stay, morbidity, and bile duct stricture, were noted. RESULTS: Three thousand seven hundred twenty-six patients were included in the final analysis. Trainee surgeons performed 31.6% of surgeries and 9.5% of these surgeries were taken over by the senior surgeon. A CVS could be delineated in 96.6% of patients. The major BDI rate was only 0.05%. CONCLUSION: This study reiterates the fact that following the basic tenets of safe laparoscopic cholecystectomy, defining and confirming CVS, and following proctored preceptorship are critical in preventing major BDI.

Does Laparoscopic Omentectomy Reduce CAPD Catheter Malfunction: A Three-arm Pilot Randomized Trial.

Introduction: Catheter malfunction secondary to omental wrapping is a frequent complication of continuous ambulatory peritoneal dialysis (CAPD). Of the various methods of peritoneal dialysis catheter insertion (PDCI), open surgical insertion under local anesthesia is most widely practiced. Laparoscopic omentectomy is often undertaken as a salvage procedure in case of malfunctioning catheters. However, there is no randomized controlled trial (RCT) to evaluate the role of prophylactic laparoscopic omentectomy on catheter function. This pilot RCT was undertaken to evaluate the impact of laparoscopic omentectomy on the incidence of catheter malfunction. Materials and Methods: Consecutive patients were randomized into three groups: laparoscopic PDCI with omentectomy (Group A), laparoscopic PDCI without omentectomy (Group B) and open surgical PDCI (Group C). The primary outcome was the incidence of catheter malfunction at 6 weeks and 3 months. Results: Forty-one patients completed follow-up, with 16, 11, and 14 patients in Groups A, B, and C, respectively. Incidence of catheter malfunction was 6.2%, 27.3%, and 14.3% in Groups A, B, and C, respectively, at 6 weeks and 6.2%, 36.4%, and 21.4% at 3 months, respectively. In patients with previously failed catheter insertion (n = 23), malfunction at 3 months was 8.3% (1/12) in patients who had omentectomy, compared with 45.5% (5/11) in those who did not (P = 0.069). Operating time was significantly higher (P < 0.001) in Group A. Conclusions: Laparoscopic omentectomy may be associated with a lower incidence of catheter malfunction, especially in patients with previously failed peritoneal dialysis catheter. Data from this pilot RCT can be used to design a large trial with an adequate number of patients.

Effect of Short-term-focused Training on a Phantom Model in Improving Operative Room Performance Among Surgical Residents: A Randomized Trial.

BACKGROUND: Meta-analysis has shown the effectiveness of various training methods for the acquisition of laparoscopic skills in surgical training. However, there is very limited literature focusing on the translation of skill acquisition on training models into improved operating room (OR) performance. This study was conducted to evaluate the effectiveness of the Tuebingen trainer with integrated Porcine tissue in improving OR the performance of surgical trainees using standard assessment tools. MATERIALS AND METHODS: The study was a single-blinded double-armed randomized control study conducted between July 2016 and March 2018. Eighteen, fourth, and fifth semesters of surgery residents were included in the study. The baseline performance was assessed in OR by performing laparoscopic cholecystectomy using validated scores, that is, Global Operative Assessment of Laparoscopic Skills (GOALS), Additional Five Criteria, Task-specific Checklist, Error Checklist, Visual Analogue Scale. The residents were then randomized into trainee and nontrainee groups. The training group received 5 days of short-term-focused training on the Tuebingen trainer, and the improvement was reassessed in OR. RESULTS: The demographic profile of residents was similar. The baseline scores were comparable. The training group showed statistically significant improvement in GOALS (9.88±1.76 to 12±0.66, P=0.05 vs. 10.33±1.5 to 11.4±2.24, P=0.28), task-specific checklist (42.22±10.92 to 53.33±14.14, P=0.027 vs. 45.55±10.13 to 50±17.32, P=0.51), and error checklist. The operating time significantly reduced (36.0±4.03 vs. 50.44±11.39, P=0.0025) following training. CONCLUSIONS: Our study concludes that the training on the Tuebingen trainer with integrated porcine organs results in a statistically significant improvement in the OR performance of surgical residents as compared with the nontrained residents, thereby indicating a transfer of skills from training to OR.

Quality of Life Outcomes Following Single-stage Laparoscopic Common Bile Duct Exploration Versus 2-stage Endoscopic Sphincterotomy Followed by Laparoscopic Cholecystectomy in Management of Cholelithiasis With Choledocholithiasis.

INTRODUCTION: With various studies in the literature showing laparoscopic common bile duct (CBD) exploration to have equal or similar results when compared with endoscopic sphincterotomy (EST) clearance, decision-making in regard to the treatment modality to be used may become debatable. Thus, quality of life (QoL) data may assist both the patient and the clinician in deciding the management of the disease. The present prospective randomized trial was undertaken to compare QoL of patients undergoing treatment with these 2 approaches. METHODOLOGY: The study was conducted March 1, 2013, to September 31, 2016. Consecutive patients with CBD stones were randomized to either laparoscopic CBD exploration with cholecystectomy (group I) and EST followed by laparoscopic cholecystectomy (group II). Diagnosis was confirmed preoperatively using magnetic resonance cholangiopancreatography and/or endoscopic ultrasound. QoL scores were assessed by World Health Organization Quality of Life-Brief Version (WHOQOL-BREF), European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) questionnaires. RESULTS: A total of 77 patients with concomitant gallstones and CBD stones were finally recruited (38 patients in group I and 39 patients in group II). The demographic and clinical profiles were similar in both the groups. On EORTC QLQ-C30 questionnaire, there was significant improvement in physical, emotional, and role functioning in both the groups (P<0.01) with no intergroup variation preprocedure or postprocedure. Patients in both the groups reported similar WHOQOL scores with significant improvement postprocedure and minimal intergroup variation. Both the depression and anxiety scores on HADS were comparable between the 2 groups preoperatively and at 3 months postoperatively. CONCLUSION: Single-stage management of patients with gallbladder and CBD stones and EST followed by laparoscopic cholecystectomy were similar in terms of improvement in QoL.

Long-term Outcomes Following Primary Closure of Common Bile Duct Following Laparoscopic Common Bile Duct (CBD) Exploration: Experience of 355 Cases at a Tertiary Care Center.

INTRODUCTION: Primary closure of common bile duct (CBD) after laparoscopic common bile duct exploration (LCBDE) is now becoming the preferred technique for closure of choledochotomy. Primary CBD closure not only circumvents the disadvantages of an external biliary drainage but also adds to the advantage of LCBDE. Here, we describe our experience of primary CBD closure following 355 cases of LCBDE in a single surgical unit at a tertiary care hospital. MATERIALS AND METHODS: All patients undergoing LCBDE in a single surgical unit were included in the study. Preoperative and intraoperative parameters including the technique of CBD closure were recorded prospectively. The postoperative recovery, complications, hospital stay, antibiotic usage, and postoperative intervention, if any, were also recorded. RESULTS: Three hundred fifty-five LCBDEs were performed from April 2007 to December 2018, and 143 were post-endoscopic retrograde cholangiopancreatography failures. The overall success rate was 91.8%. The mean operative time was 98±26.8 minutes (range, 70 to 250 min). Transient bile leak was seen in 10% of patients and retained stones in 3 patients. Two patients required re-exploration and 2 patients died in the postoperative period. Follow-up ranged from 6 months to 10 years, with a median follow-up of 72 months. No long-term complications such as CBD stricture or recurrent stones were noted. CONCLUSIONS: Primary closure of CBD after LCBDE is safe and associated with minimal complications and no long-term problems. The routine use of primary CBD closure after LCBDE is recommended based on our experience.

Comparison of Absorbable Versus Nonabsorbable Tackers in Terms of Long-term Outcomes, Chronic Pain, and Quality of Life After Laparoscopic Incisional Hernia Repair: A Randomized Study.

BACKGROUND: Laparoscopic incisional and ventral hernia repair (LIVHR) has been associated with a high incidence acute and chronic pain due to use of nonabsorbable tackers. Several absorbable tackers have been introduced to overcome these complications. This randomized study was done to compare 2 techniques of mesh fixation, that is, nonabsorbable versus absorbable tackers for LIVHR. MATERIALS AND METHODS: Ninety patients admitted for LIVHR repair (defect size <15 cm) were randomized into 2 groups: nonabsorbable tacker fixation (NAT group, 45 patients) and absorbable tacker fixation (AT group, 45 patients). Intraoperative variables and postoperative outcomes were recorded and analyzed. RESULTS: Patients in both the groups were comparable in terms of demographic profile and hernia characteristics. Mesh fixation time and operation time were also comparable. There was no significant difference in the incidence of immediate postoperative and chronic pain over a mean follow-up of 8.8 months. However, cost of the procedure was significantly higher in AT group (P<0.01) and NAT fixation was more cost effective as compared with AT. Postoperative quality of life outcomes and patient satisfaction scores were also comparable. CONCLUSIONS: NAT is a cost-effective method of mesh fixation in patients undergoing LIVHR with comparable early and late postoperative outcomes in terms of pain, quality of life, and patient satisfaction scores.

Perception of sex workers of Lucknow City, Uttar Pradesh, India towards sexually transmitted infections.

The prevention, control, and management of sexually transmitted infections/reproductive tract infection (STI/RTI) are well-recognized cost-effective strategies for controlling the spread of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). A cross-sectional descriptive study was done over a period of 1 year to assess the prevalence of STI, knowledge level about STI, and the STI-HIV link among the female sex workers (FSWs) of Lucknow city, Uttar Pradesh, India along with their biosocial characteristics. Most of the FSWs were illiterate, married, Hindus, and belonged to general category. The prevalence rates of STI among street-based and home-based FSWs were 50.6% and 29.8%, respectively. Knowledge about the role of condom in prevention of STI and the STI-HIV link was significantly less among home-based FSWs than those who are street-based. There is a great lack in the awareness among FSWs regarding STI and their prevention. Behavior change communication (BCC) and advocacy strategy were developed, especially for the home-based group, to strengthen their knowledge regarding the STI-HIV link.