Enhanced recovery pathway in open and minimally invasive colorectal cancer surgery: a prospective study on feasibility, compliance, and outcomes in a high-volume resource limited tertiary cancer center.

BACKGROUND: Enhanced recovery program (ERP) has demonstrated improved postoperative outcomes with increased compliance to pathway. However, there is scarce data on feasibility and safety in resource limited setting. The objective was to assess compliance with ERP and its impact on postoperative outcomes and return to intended oncological treatment (RIOT). METHODS: A single center prospective observational audit was conducted from 2014 to 2019, in elective colorectal cancer surgery. Before implementation, multi-disciplinary team was educated regarding ERP. Compliance to ERP protocol and its elements was recorded. Impact of quantum of compliance (≥80% vs. <80%) to ERP on postoperative morbidity, mortality, readmission, stay, re-exploration, functional GI recovery, surgical-specific complications, and RIOT was evaluated for open and minimal invasive surgery (MIS). RESULTS: During study, 937 patients underwent elective colorectal cancer surgery. Overall compliance with ERP was 73.3%. More than 80% compliance was observed in 332 (35.4%) patients in the entire cohort. Patients with <80% compliance had significantly higher overall, minor and surgery-specific complications, longer postoperative stay, delayed functional GI recovery for both open and MIS procedures. RIOT was observed in 96.5% patients. Duration to RIOT was significantly shorter following open surgery with ≥80% compliance. Compliance <80% to ERP was identified as one of the independent predictors for developing postoperative complications. CONCLUSION: The study demonstrates beneficial impact of increased compliance to ERP on postoperative outcomes following open and minimally invasive surgery for colorectal cancer. Within a resource limited setting, ERP was found to feasible, safe, and effective in both open and minimally invasive colorectal cancer surgery.

Mist nebulizer versus heated humidifier on endotracheal tube patency in spontaneously breathing intubated patients: A prospective, randomized controlled trial.

Background and Aims: Using a humidifier in intubated patients is now a standard of care as the humidifying effect of the upper airway is lost. We conducted this study to compare the efficacy of a heated humidifier (HH) with the more commonly used conventional mist nebulizer on overnight intubated and spontaneously breathing post-operative patients. Material and Methods: This prospective, randomized control trial included 60 post-operative overnight intubated and spontaneously breathing patients, of which 30 patients were allocated to the HH group and 30 to the mist nebulizer group. The reduction of endotracheal tube (ETT) patency was measured quantitatively by the difference between the pre-intubation and immediate post-extubation ETT volume and compared between the two groups. Also, the characteristics of secretion, the temperature of inspired gas at the Y-piece, and the frequency of refilling the humidifier chamber were recorded and compared. Results: The reduction of ETT volume was significantly more in the mist nebulizer group compared to the HH group (P-value 0.00026). The mean temperature of the inspired gas (°C) was higher in the HH group (P-value < 0.0001). More patients in the mist nebulizer group had thicker (P-value 0.057) and drier secretions (P-value 0.005) compared to the HH group. None of the patients in the HH group required refilling of the humidifier chamber while the mean frequency of the refilling was 3.5 times per patient in the mist nebulizer group. Conclusion: HH may be preferred over mist nebulizer as the latter requires more frequent refilling which may not be practically possible in a busy recovery room rendering the patient at the risk of inhaling dry gas and consequent thick and dry secretions with decreased ETT patency.

Impact of enhanced recovery pathway in 408 gallbladder cancer resections.

BACKGROUND: Gallbladder cancer (GBC) is the sixth most common gastrointestinal malignancy with poor prognosis. Enhanced Recovery Pathway (ERP) is associated with improved outcomes following abdominal surgical procedures. Currently, there is no study evaluating ERP in patients undergoing GBC surgery. The objective was to assess compliance with ERP elements and evaluate its impact on postoperative outcomes. METHODS: Prospective study conducted from February 2014-2019, including elective GBC surgery. Team was educated prior to ERP implementation. Compliance with the protocol, functional gastrointestinal (GI) recovery, mobilisation, and postoperative outcomes were recorded. Impact of degree of compliance (more or less than 80%) with ERP and postoperative outcomes was evaluated. RESULTS: In 408 patients, compliance with ERP was 84.6% (53.8-100%). Compliance >80% with ERP elements was observed in 245 patients (60%). Patients with >80% compliance had lower rate of minor (18.8% vs. 27%, p = 0.050) and significantly less major (0.8% vs. 6.1%, p = 0.002) and postoperative stay (5.84 ± 4.86 vs. 7.55 ± 6.6 days, p < 0.001) and earlier functional GI recovery. Intraoperative blood loss more than 600 ml, lower compliance (<80%) with ERP and preoperative albumin independently predicted postoperative complications. CONCLUSION: This study demonstrates safety and efficacy of enhanced recovery pathway in gallbladder cancer. Higher compliance with the pathway was associated with significantly improved postoperative outcomes following gallbladder cancer surgery.

Avoiding Hemolytic Anemia by Understanding the Effect of the Molecular Architecture of Gemini Surfactants on Hemolysis.

Hemolytic behavior of a series of different categories of Gemini surfactants was determined in their low concentration range. Cationic Gemini surfactants of different molecular architectures prove to be highly cytotoxic even at 0.1 mM. Anionic and amino acid-based Gemini surfactants were minimally cytotoxic, although their toxicity was concentration-dependent. With respect to monomeric surfactants of comparable hydrocarbon chain lengths, cationic Gemini surfactants were much more toxic than anionic Gemini surfactants. Incubation temperature was another important parameter that significantly drove the hemolysis irrespective of the molecular structure of the surfactant. Results indicated that the surface activity or liquid-blood cell membrane adsorption tendency of a surfactant molecule determined the degree of hemolytic anemia. Greater surface activity induced greater cytotoxicity, especially when the surfactant possessed a stronger ability to interact with the membrane proteins through hydrophilic interactions. That provided cationic Gemini surfactants a higher ability for hemolytic anemia because they were able to interact with an electronegative cell membrane with favorable interactions in comparison to anionic or amino acid-based Gemini surfactants. These findings are expected to help in designing surface-active drugs with a suitable molecular architecture that can avoid hemolytic anemia.

Preoperative Albumin-Globulin Ratio and Its Association with Perioperative and Long-Term Outcomes in Patients Undergoing Pancreatoduodenectomy.

BACKGROUND: Systemic inflammatory response is involved in natural progression of cancers by different pathways. Albumin-globulin ratio (AGR) has been reported to have impact on prognosis in various solid tumors. OBJECTIVE: To study the significance of AGR on perioperative and long-term outcomes in patients undergoing PD. METHODS: This is a post hoc analysis of the pancreatic surgery database from January 2012 to March 2017. Cutoff value for AGR was calculated by using the receiver operating curve, and the study cohort was divided into group I (AGR ≥1) and group II (AGR <1). Two groups were compared for perioperative and long-term survival outcomes. RESULTS: Two groups were comparable with respect to clinicodemographic variables. Groups I and II had similar perioperative outcomes (p > 0.05) like median hospital stay (14 vs. 15 days), clinically relevant postoperative pancreatic fistula (16.6 vs. 15.7%), hemorrhage (3.1 vs. 2.6%), bile leak (1.4 vs. 0.65%), overall morbidity (30.1 vs. 28.9%), and postoperative mortality (2.7 vs. 3.9%). With a median follow-up of 3 years, median survival, overall survival, and disease-free survival were similar in both groups. CONCLUSION: AGR at the cutoff value of ≥1 was not associated with adverse perioperative and long-term oncological outcomes after PD.

Off-label Medication Use: A Double-edged Sword.

Agarwal V. Off-label Medication Use: A Double-edged Sword. Indian J Crit Care Med 2021;25(8):845-846.

Postoperative Outcomes Following Elective Surgery in India.

INTRODUCTION: The incidence of complications and mortality in patients undergoing elective surgery in India are unknown. We contributed Indian data to ISOS. Since there were fewer than ten centers, Indian data were not included in the primary analysis. We report postoperative outcomes in the Indian data set of patients following elective surgery. MATERIALS AND METHODS: In this prospective 7-day observational study, after obtaining a waiver of informed consent, data were collected for 30 days from consecutive patients >18 years undergoing elective surgery. The primary outcome was in-hospital postoperative complications. The secondary outcomes were in-hospital all-cause mortality, the relationship between postoperative complications and admission to critical care, and the duration of hospital stay. Complications were graded as mild, moderate, and severe. Failure to rescue was defined as mortality in patients admitted to an intensive care unit (ICU) for the treatment of complications. RESULTS: Complications occurred in 57 (27.5%) patients, who were older (53 vs 47 years, p < 0.001) and had American Society of Anaesthesiologists grades III and IV physical status (p = 0.029). One hundred and thirty-eight (65.7%) patients underwent a major surgical procedure of which 132 (62.8%) procedures were done for malignancy. Postoperative complications were significantly higher (41.5% vs 22.7%) in patients electively admitted to ICU. The overall mortality rate was 2.4%, whereas the mortality rate was 8.8% in those who developed complications. CONCLUSION: We found that 28% of patients developed postoperative complications. The overall mortality was 2.4% but was higher (8.8%) in those who developed complications. Age and complex surgical procedures independently predicted complications, while lower preoperative hemoglobin appeared to be protective. STUDY REGISTRATION: ISRCTN51817007. HOW TO CITE THIS ARTICLE: Agarwal V, Muthuchellappan R, Shah BA,Rane PP, Kulkarni AP, et al. Postoperative Outcomes Following Elective Surgery in India. Indian J Crit Care Med 2021;25(5):528-534.

Correction to: Twelve Hundred Consecutive Pancreato-Duodenectomies from Single Centre: Impact of Centre of Excellence on Pancreatic Cancer Surgery Across India.

The authors' affiliations are updated as reflected here.

Twelve Hundred Consecutive Pancreato-Duodenectomies from Single Centre: Impact of Centre of Excellence on Pancreatic Cancer Surgery Across India.

BACKGROUND: Pancreato-duodenectomy (PD) is a technically challenging operation with significant morbidity and mortality. Over the period of time, Tata Memorial Centre has evolved into a high-volume centre for management of pancreatic cancer. Aim of this study is to report the short- and long-term outcomes of 1200 consecutive PDs performed at single tertiary cancer centre in India. METHODS: 1200 PDs were performed from 1992 to 2017. Prospectively maintained database was used to retrospectively assess the short- and long-term outcomes. RESULTS: Study cohort was divided into periods A and B (500 and 700 patients, respectively). Both groups were comparable for demographic variables. Overall morbidity and mortality in entire cohort were 31.2% and 3.9%, respectively. Period B documented significant reduction in post-operative mortality (5.4% vs 2.8%), post-pancreatectomy haemorrhage (5.8% vs 3%) and bile leaks (3.4% vs 1.3%). However, incidence of delayed gastric emptying and clinically relevant post-operative pancreatic fistula was higher in period B. With median follow-up of 25 months, 3-year overall survival and disease-free survival for patients with pancreatic cancer were 43.7% and 38.7%, respectively, and that for periampullary tumours were 65.9% and 59.4%, respectively. Period B also corresponded with dissemination of technical expertise across diverse regions of India with specialised training of 35 surgeons. CONCLUSION: Our study demonstrates the feasibility of delivering high-quality care in a dedicated high-volume centre even in a country with low incidence of pancreatic cancer with marked disparities in medical care and socio-economic conditions. Improved outcomes underscore the need to promote regionalisation via a dedicated training programme.

Complications after Supramajor Gastrointestinal Surgery: Role of Enhanced Recovery after Surgery.

BACKGROUND: Enhanced recovery after surgery (ERAS) is currently the standard of care in perioperative medicine, but it is widely underutilized in our healthcare setting because of the lack of awareness of benefits exerted by ERAS and its components. ERAS is a multidisciplinary collaboration, where intensivists play an important role in the implementation of the protocol during the perioperative period. AIM: This review article aims to appraise the role of ERAS pathway on complications following supramajor gastrointestinal surgery. REVIEW: A summary and review of evidence was conducted on the role of ERAS and its elements on non-specific and surgery-specific complications. Enhanced recovery pathways (ERPs) and its elements were directly found to be associated with lower incidence of hospital-associated infections, postoperative ileus, and postoperative pulmonary complications. Although there are no specific elements of ERPs found to have beneficial effect in preventing major adverse cardiac and cerebrovascular events, and surgery-specific complications such as postoperative pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, post-hepatic liver failure, bile, and anastomotic leak, studies have demonstrated that implementation of an ERP bundle can decrease the incidence of these complications. Implementation of an ERP was associated with an increase in the incidence of acute kidney injury with minor elevations in creatinine that returned to baseline before discharge. CONCLUSION: Although there is ample evidence that ERAS is beneficial in reducing complications and hospital stay following supramajor gastrointestinal surgery, there is scope for further research to unravel the role of ERAS on patient-reported outcomes. HOW TO CITE THIS ARTICLE: Thomas M, Joshi R, Bhandare M, Agarwal V. Complications after Supramajor Gastrointestinal Surgery: Role of Enhanced Recovery after Surgery. Indian J Crit Care Med 2020;24(Suppl 4):S205-S210.

Accuracy of ultrasound imaging versus manual palpation for locating the intervertebral level.

BACKGROUND AND AIMS: Efficacy of epidural analgesia depends on placement of the epidural catheter at the appropriate level. Manual palpation using surface landmarks to identify the desired intervertebral level may not be a reliable method. Ultrasonography (USG) is an alternative technique but requires training and may increase procedure time. The objective of this study was to compare the accuracy of ultrasound (US) imaging with manual palpation for locating the intervertebral level. MATERIAL AND METHODS: We included postoperative adult patients without an epidural catheter who were scheduled to have a chest radiograph in the recovery room. A radio-opaque marker was placed at random at an intervertebral space along the thoracic or lumbar spine of the patient (in the field of the chest radiograph). The level of intervertebral space corresponding to the radio-opaque marker was determined by palpation technique by one anesthetist. Two other anesthetists (A and B) blinded to the result of manual palpation, independently used USG to determine the level of intervertebral space. A consultant radiologist assessed the radiographs to determine the correct position of the marker, which was judged to be the accurate space. RESULTS: We recruited a total of 71 patients, of which 64 patients were included in the final analysis. Accurate identification by manual method was 31/64 (48%), by US A was 27/64 (42%) and by US B was 22/64 (34%). The difference in accuracy between manual palpation and US imaging was not statistically significant (P = 0.71). CONCLUSION: US imaging may not be superior to manual palpation for identifying intervertebral level.

Awareness during general anesthesia: An Indian viewpoint.

BACKGROUND AND AIMS: The incidence of intra-operative awareness with explicit recall in the Western world has been reported to be between 0.1% and 0.2% in the general surgical population and up to 1-2% of patients at high risk for this complication. Awareness in the Indian population has never been studied; we therefore wanted to detect the incidence of awareness in patients who were at high risk of experiencing awareness during surgery in our population. MATERIAL AND METHODS: We conducted a prospective single-center observational study at a 600-bedded tertiary cancer care referral hospital. We recruited adult patients posted for major cancer surgery who were considered to be at high risk for awareness. These patients were interviewed at three time-points using the structured modified Brice interview questionnaire. The primary outcome studied was the incidence of definite intra-operative awareness. RESULTS: A total of 934 patients were included in the final analysis of which none reported awareness. Using the rule of three (Hanley and Lippman-Hand) we conclude that the upper 95% confidence interval for the incidence of awareness in this population is <1 in 300 (0.33%). CONCLUSION: Awareness under anesthesia is a distressing complication with a potential for long-term psychological consequences, and every effort should be undertaken to prevent it. It is reassuring though that our data in Indian cancer patients at high risk for intra-operative awareness suggests that it is an uncommon occurrence.

Agreement between inferior vena cava diameter measurements by subxiphoid versus transhepatic views.

CONTEXT: Correcting hypovolemia is extremely important. Central venous pressure measurement is often done to assess volume status. Measurement of inferior vena cava (IVC) is conventionally done in the subcostal view using ultrasonography. It may not be possible to obtain this view in all patients. AIMS: We therefore evaluated the limits of agreement between the IVC diameter measurement and variation in subcostal and that by the lateral transhepatic view. SETTINGS AND DESIGN: Prospective study in a tertiary care referral hospital intensive care unit. SUBJECTS AND METHODS: After Institutional Ethics Committee approval and informed consent, we obtained 175 paired measurements of the IVC diameter and variation in both the views in adult mechanically ventilated patients. The measurements were carried out by experienced researchers. We then obtained the limits of agreement for minimum, maximum diameter, percentage variation of IVC in relation to respiration. STATISTICAL ANALYSIS USED: Bland-Altman's limits of agreement to get precision and bias. RESULTS: The limits of agreement were wide for minimum and maximum IVC diameter with variation of as much as 4 mm in both directions. However, the limits of agreement were much narrower when the percentage variation in relation to respiration was plotted on the Bland-Altman plot. CONCLUSIONS: We conclude that when it is not possible to obtain the subcostal view, it is possible to use the lateral transhepatic view. However, using the percentage variation in IVC size is likely to be more reliable than the absolute diameter alone. It is possible to use both views interchangeably.

Acute postoperative pain management techniques, their efficacy and complications after major gastrointestinal and hepato-pancreato-biliary cancer surgeries: An observational study.

BACKGROUND: Patients undergoing major gastrointestinal (GI) surgery including hepato-pancreato-biliary (HPB) surgeries have large incisions, which cause severe acute postoperative pain that, if untreated, is associated with a higher incidence of postoperative morbidity and delayed recovery. METHODOLOGY: Our study included all patients who underwent elective major upper GI and HPB surgeries from 1 January 2018 to 31 December 2018. The patients were divided into two groups: the epidural and the non-epidural group. The average and worst pain scores at rest and movement were compared between both groups. We also studied the effect of pain relief in the two groups and associated postoperative outcomes, resumption of feeding, ambulation, hospital stay and intensive care unit stay. RESULTS: A total of 566 patients were included in the study, out of which 490 received epidurals, and the rest, 76, belonged to the non-epidural group (transversus abdominis plane, rectus sheath block or no regional analgesia technique). The median average pain score at rest and movement was 2.0 and 3.0, respectively, in the epidural and non-epidural groups. The postoperative outcomes showed no statistical difference. CONCLUSION: The epidural group and the non-epidural group had similar pain scores, and the postoperative outcomes were also comparable.

Evaluation of perioperative routine coagulation testing versus thromboelastography for major liver resection - A single-arm, prospective, interventional trial (PORTAL trial).

Background and Aims: The International Normalised Ratio (INR), which assesses the loss of procoagulant factors in the extrinsic pathway, fails to evaluate the coagulation abnormalities comprehensively after a major liver resection, which often leads to reduced synthesis of procoagulant and anticoagulant-factors. This study was conducted with an aim to study the trend and compare the results of routine coagulation tests and thromboelastography (TEG) during the perioperative period in patients undergoing major liver resections (≥3 segments). Methods: Twenty-five patients who underwent a major liver resection were enrolled. This prospective, single-arm, interventional study was performed with the primary objective of determining the serial changes in conventional coagulation tests and TEG during the perioperative period in patients undergoing major liver resections, at the preincision period, intraoperative period, postoperatively, at 48 h and on the fifth postoperative day. Transfusion requirements of blood components were also assessed with a TEG-guided replacement strategy. Spearman rank-order correlation was used to study the relationships of coagulation tests (both TEG and conventional tests) at each time point. Results: The prothrombin time (PT)-INR was elevated in 14 patients (56%) at the intraoperative, immediate postoperative and 48-h time points in contrast to the TEG parameters, which remained normal in all patients. Blood component transfusion was avoided in 4, 11 and 10 patients at the intraoperative, immediate postoperative and 48-h time points, respectively. Conclusion: International Normalised Ratio overestimates the coagulopathy in patients undergoing major liver resection, and a thromboelastography-guided transfusion strategy reduces overall transfusion requirements.

Hemolytic Response of Iron Oxide Magnetic Nanoparticles at the Interface and in Bulk: Extraction of Blood Cells by Magnetic Nanoparticles.

Surface-active and water-soluble magnetic nanoparticles (NPs) were synthesized in the presence of a series of amphiphilic molecules of different functional groups to determine the hemolytic response and their ability to extract blood cells across the interface and aqueous bulk while maintaining minimum hemolysis. Amphiphilic molecules such as Gemini surfactants of strong hydrophobicity and low hydrophilic-lipophilic balance produced surface-active magnetic NPs, which were highly cytotoxic even when placed at the blood suspension (aqueous)-air interface. A similar behavior was shown by water-soluble magnetic NPs produced using monomeric ionic and nonionic surfactants and different amino acids. The NPs produced using mild biological surfactants and mono- and oligosaccharides of the same functional group proved to be excellent blood cell extractors with minimum hemolysis. α/ß-cyclodextrin and dextrose-stabilized magnetic NPs induced negligible hemolysis and extracted more than 50% of blood cells. The results showed that nontoxic magnetic NPs are excellent blood cell extractors from the blood suspension when tagged with amphiphilic molecules possessing good biocompatibility with cell membranes without inducing hemolysis. The work highlights the biological applicability of nontoxic magnetic NPs at biointerfaces and in blood suspensions.

An Integrated Surgical Management for Giant Dermatofibrosarcoma Protuberans of Anterior Abdominal Wall.

Giant dermatofibrosarcoma protuberans (DFSP) is a very rare dermal sarcoma whose diagnosis and management are important because of the high local recurrence but low metastatic potential. Complete surgical excision of giant DFSP in a single stage is difficult but has a high cure rate. A 47-year-old man presented with a gradually increasing large (18 x 15 x 7 cm) DFSP in the epigastrium. A 3 cm circumferential wide local excision (WLE) with microscopic tumor-free margin confirmed by frozen section was performed. Immediate single staged tension-free primary closure of resultant defect was done on the principle of abdominal wall reconstruction (AWR) in ventral hernia repair. This technique of anterior component separation and bridge meshplasty is functional, avoids multiple surgeries, is cost-effective, and can be done in a resource-limited setting in developing countries. A multidisciplinary and integrated surgical approach to treat giant DFSP over epigastrium, by three-dimensional WLE and immediate AWR with anterior component separation technique (CST) and bridging meshplasty, can be of immense help in managing such rare cases in developing countries.