The impact of a perioperative pulmonary care bundle implementation on postoperative outcomes in 1,665 surgical cancer patients: experience from a tertiary referral cancer center in Jordan.

BACKGROUND: Postoperative pulmonary complications can be a major catastrophic consequence of major surgeries and can lead to increased morbidity, mortality, hospital stay, and cost. Many protocols have been tried to reduce serious adverse outcomes with effective strategies including a bundle of preoperative, intraoperative and postoperative techniques. Using these techniques maybe challenging in developing countries with limited resources even in specialized centers. METHODS: A before-and-after trial comparing our data from the national surgical quality improvement program (NSQIP) based on their reports. Data was collected prospectively for the patients who underwent major surgeries at King Hussein Cancer Center during the year 2017 when the use of the perioperative pulmonary care bundle was mandatory to all surgery teams and compared it with the data collected retrospectively for the patients who underwent the same type of surgeries in the year 2016 when the use of such a bundle was optional. The primary end point is the decrease in incidence of postoperative pulmonary complications. Simple descriptive statistical analysis was used to obtain results. RESULTS: The potential risk factors for postoperative pulmonary complications for 1665 patients divided into 2 groups (2016 vs. 2017); 764 (45.9%) vs. 901 (54.1%), respectively. There were no significant differences regarding gender (male 46.7% vs. 46.4%, P value = 0.891, female 53.3% vs. 53.6%, P value = 0.39), mean of age (53.5 year vs. 5.28 year, P value = 0.296), mean of body mass index (BMI) (28.6 vs. 6%, 28.6, P value = 0.95), smoking status; (69.6% vs. 65.1%, P value = 0.052), ventilator use (0.3% vs. 0.4% P value = 0.693) and chronic obstructive pulmonary disease (1.4% vs. 1.4 with, P value = 0.996).The data showed a significant reduction in postoperative pneumonia between the 2 groups (2016 vs. 2017) (2.7% vs. 0.9%, P value = 0.004) and showed a significant reduction in unplanned intubation, 1.4% in 2016 vs. 0.7% in 2017. CONCLUSIONS: The standardization of perioperative pulmonary care bundle, including smoking cessation, perioperative pulmonary interventions and early mobilization, significantly reduces the incidence of postoperative pulmonary complications in cancer patients. This technique's implementation was feasible easily even with limited resources in a developing country like Jordan.

Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma.

BACKGROUND: Neoadjuvant chemotherapy and short-course radiotherapy followed by resection has been gaining recognition in the treatment of rectal cancer. Avelumab is a fully human immunoglobulin that binds Programmed Death-Ligand 1 (PD-L1) and prevents the suppression of the cytotoxic T cell immune response. This phase II trial evaluates the safety and pathologic response rate of short-course radiation followed by 6 cycles of mFOLFOX6 with avelumab in patients with locally advanced rectal cancer (LARC). METHODS: This study is prospective single-arm, multicenter phase II trial adopting Simon's two-stage. Short-course radiation is given over 5 fractions to a total dose of 25 Gy. mFOLFOX6 plus avelumab (10 mg/kg) are given every 2 weeks for 6 cycles. Total mesorectal excision is performed 3-4 weeks after the last cycle of avelumab. Follow up after surgery is done every 3 months to a total of 36 months. Adverse event data collection is recorded at every visit. RESULTS: 13 out of 44 patients with LARC were enrolled in the first stage of the study (30% from total sample size). All patients met the inclusion criteria and received the full short-course radiation course followed by 6 cycles of mFOLFOX6 plus avelumab. 12 out of the 13 patients completed TME while one patient had progression of disease and was dropped out of the study. The sample consisted of 9 (69%) males and 4 (31%) females with median age of 62 (33-73) years. The first interim analysis revealed that 3 (25%) patients achieved pathologic complete response (pCR) (tumor regression grade, TRG 0) out of 12. While 3 (25%) patients had near pCR with TRG 1. In total, 6 out of 12 patients (50%) had a major pathologic response. All patients were found to be MMR proficient. The protocol regimen was well tolerated with no serious adverse events of grade 4 reported. CONCLUSION: In patients with LARC, neoadjuvant radiation followed by mFOLFOX6 with avelumab is safe with a promising pathologic response rate. Trial Registration Number and Date of Registration ClinicalTrials.gov NCT03503630, April 20, 2018. https://clinicaltrials.gov/ct2/show/NCT03503630?term=NCT03503630&draw=2&rank=1 .

Short-course radiation followed by mFOLFOX-6 plus avelumab for locally-advanced rectal adenocarcinoma.

BACKGROUND: Current standard practice for locally advanced rectal cancer (LARC) entails a multidisciplinary approach that includes preoperative chemoradiotherapy, followed by total mesorectal excision, and then adjuvant chemotherapy. The latter has been accompanied by low compliance rates and no survival benefit in phase III randomized trials, so the strategy of administering neoadjuvant, rather than adjuvant, chemotherapy has been adapted by many trials, with improvement in pathologic complete response. Induction chemotherapy with oxaliplatin has been shown to have increased efficacy in rectal cancer, while short-course radiation therapy with consolidation chemotherapy increased short-term overall survival rate and decreased toxicity levels, making it cheaper and more convenient than long-course radiation therapy. This led to recognition of total neoadjuvant therapy as a valid treatment approach in many guidelines despite limited available survival data. With the upregulation (PDL-1) expression in rectal tumors after radiotherapy and the increased use of in malignant melanoma, the novel approach of combining immunotherapy with chemotherapy after radiation may have a role in further increasing pCR and improving overall outcomes in rectal cancer. METHODS: The study is an open label single arm multi- center phase II trial. Forty-four recruited LARC patients will receive 5Gy x 5fractions of SCRT, followed by 6 cycles of mFOLFOX-6 plus avelumab, before TME is performed. The hypothesis is that the addition of avelumab to mFOLFOX-6, administered following SCRT, will improve pCR and overall outcomes. The primary outcome measure is the proportion of patients who achieve a pCR, defined as no viable tumor cells on the excised specimen. Secondary objectives are to evaluate 3-year progression-free survival, tumor response to treatment (tumor regression grades 0 & 1), density of tumor-infiltrating lymphocytes, correlation of baseline Immunoscore with pCR rates and changes in PD-L1 expression. DISCUSSION: Recent studies show an increase in PD-L1 expression and density of CD8+ TILs after CRT in rectal cancer patients, implying a potential role for combinatory strategies using PD-L1- and programmed-death- 1 inhibiting drugs. We aim through this study to evaluate pCR following SCRT, followed by mFOLFOX-6 with avelumab, and then TME procedure in patients with LARC. TRIAL REGISTRATION: Trial Registration Number and Date of Registration: ClinicalTrials.gov NCT03503630, April 20, 2018.

A Case-matched Comparative Study of Laparoscopic Versus Open Right Colonic Resection for Colon Cancer: Developing Country Perspectives.

BACKGROUND: The open approach to right hemicolectomy remains the most widely adopted, whereas laparoscopic surgery is technically more demanding with possible loss of benefit for lengthy procedures compared with open surgery. The aim of this study is to compare the outcomes of the laparoscopic versus open surgery for right colon cancer resections. MATERIALS AND METHODS: Patients who underwent an elective and potentially curative right colectomy for colon cancer between 2015 and 2019 were included and those who underwent emergency surgery, palliative resection, or cytoreductive surgery were excluded. Patients were randomly matched on 1:2 basis for age, disease stage, neoadjuvant chemotherapy, and extent of colectomy (right vs. extended right hemicolectomy, and additional major resection). The analysis was conducted on an intention-to-treat basis. The outcomes were reported as median (range) or percent as appropriate. RESULTS: Among 160 patients, 18 were excluded. The final matching included 69 patients. The were no significant differences between the groups regarding patients' age and sex distribution, tumor size, and preoperative serum albumin and hemoglobin. There were 2 conversions (8.7%) to open surgery. Although the operating time for laparoscopic surgery was longer (200 vs. 140 min, P<0.001), it was associated with less blood loss (50 vs. 100 mL, P=0.001) and shorter primary and total hospital stay (4.1 vs. 6.0 days, P<0.001). There were no differences in the rates of severe complications (0% vs. 13%), reoperations (0% vs. 4.3%), readmissions (13% vs. 8.7%), mortality (0% vs. 2.2%), R0 resections (95.7% vs. 97.8%), and lymph node retrieval rate (28 in each group). CONCLUSION: The laparoscopic approach to right colon resection for colon cancer is associated with less operative trauma and quicker recovery compared with open surgery and offers an equivalent oncologic resection.

Laparoscopic Versus Open D2 Gastrectomy for Gastric Cancer: A Case-Matched Comparative Study.

Background: The role of the laparoscopic approach to D2 gastrectomy for gastric cancer remains controversial. The aim of this study was to compare the operative and short-term oncologic outcomes of laparoscopic versus open resections. Methods: Patients who underwent potentially curative D2 gastrectomy between 2017 and 2019 were retrospectively reviewed. Patients were randomly matched on 1:1 basis for age and extent of surgery (total versus subtotal gastrectomy, and additional organ resection). Exclusions included emergency or palliative surgery. The learning curve for laparoscopic resections was included. Analysis was conducted on intention to treat basis. The outcomes were reported as median (range) or per cent as appropriate. Results: Among 78 patients who had undergone potentially curative gastrectomy 36 were matched. The groups were comparable for age, sex, American Society of Anesthesiologists (ASA) score, preoperative serum albumin and hemoglobin, body mass index, frequency of previous abdominal surgery, anatomic distribution of disease, extent of gastrectomy, need for additional resection, and disease stage. There was one conversion to open surgery. Although laparoscopic surgery required longer operating time (393 versus 218 minutes, P < .001), it was associated with less blood loss (100 versus 200 mL, P = .001) and shorter hospital stay (3.0 versus 7.5 days, P < .001). There were no significant differences in the rates of clinically significant complications, mortality, readmissions, reoperations, lymph node retrieval, and R1 resections. Conclusions: The laparoscopic approach to potentially curative D2 gastrectomy for gastric cancer is associated with less operative trauma and quicker recovery while offering an equivalent oncologic resection.

A Case-matched Comparative Study of Laparoscopic Versus Open Pancreaticoduodenectomy.

BACKGROUND: The laparoscopic approach to pancreaticoduodenectomy (LPD) is technically demanding, but may offer benefits over open surgery [open pancreaticoduodenectomy (OPD)]. The aim of this study was to compare the outcomes of these 2 approaches at a tertiary cancer center from the Middle East. MATERIALS AND METHODS: Fifty consecutive patients who underwent LPD (n=12) and OPD (n=38) between 2015 and 2018 were considered. One surgeon performed LPD for "all comers," while 3 other surgeons performed open surgery. Patients were randomly matched on a 1:2 basis for pathology (benign vs. malignant), malignancy size (±1 cm), and whether the pancreatic duct was dilated (>3 mm). RESULTS: Six patients were excluded, leaving 44 patients, of whom 33 were matched (LPD n=11, OPD n=22). The groups were comparable for age (57 vs. 63 y, P=0.123) and sex distribution (female; 55% vs. 45%, P=0.721), tumor size (3 cm in each group), frequency of pancreatic duct dilatation (45% in each group), and malignant pathology (82% in each group). There were no conversions to open surgery. Although the operating time for LPD was significantly longer (680 vs. 313 min, P<0.0001), LPD was associated with significantly shorter primary (4.7 vs. 7.8 d, P<0.0001) and total hospital stay that included readmissions (4.7 vs. 8.9 d, P<0.0001). There were no significant differences in blood loss (200 vs. 325 mL, P=0.082), overall complication rate (36.4% vs. 59.1%, P=0.282), or clinically significant complications (9.1% vs. 22.2%, P=0.643) and readmissions (0 vs. 4 patients). In patients with malignant disease, there were no differences with regard to the number of lymph nodes retrieved (18 vs. 12, P=0.095) and frequency of R0 resections (77.8% in each group). CONCLUSION: In experienced hands, the laparoscopic approach to pancreaticoduodenectomy seems to offer advantages over open surgery in terms of reduction in hospital stay while maintaining an equivalent oncologic resection.

Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial.

BACKGROUND/PURPOSE: Seroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial. METHODS: This is a single-center, randomized, single-blinded, and two-arm parallel study. Women with node-positive breast cancer eligible for axillary dissection were enrolled. Patients with a Body Mass Index (BMI) greater than 35 kg/m2, those who underwent immediate breast reconstruction, and/or received neoadjuvant chemotherapy were excluded. Patients were randomized in a 1:1 ratio, and were stratified according to their age, BMI, tumor size, and operation type. The primary endpoint was the total seroma volume (the total drained volume and the total aspirated volume after drain removal). Data presented as mean and range when applicable. RESULTS: 111 patients were randomized (Cyanoacrylate 57; control 54). 105 patients were analyzed. Sixty-nine patients underwent breast conserving surgery, and 36 underwent modified radical mastectomy. There was no difference in the total seroma volume between the Cyanoacrylate vs. control arms (1,304 (60-4,950) vs. 1,446 (100-5,223) ml, p=0.458). Wound infection, flap necrosis, number of manual aspirates, and hematoma formation were not statistically different between the two groups. Time to drain removal was shorter in the Cyanoacrylate arm (11.04(3-23) vs. 13.84(3-37) days, p=0.015). The use of Cyanoacrylate was not cost effective ($586.93 (550-748) vs. $29.63 (0-198), p<0.001). Higher seroma volume was correlated with modified radical mastectomy, older age, and BMI more than 30 kg/m2. CONCLUSION: Cyanoacrylate did not reduce seroma formation and its use was not cost effective. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, identifier NCT02141373.

Improvement in Adherence to Surgical Antimicrobial Prophylaxis Guidelines after Implementation of a Multidisciplinary Quality Improvement Project.

OBJECTIVES: This study aimed to show the impact of a multidisciplinary quality improvement project on adherence to antimicrobial prophylaxis guidelines in oncological surgery. METHODS: This pre- and post-intervention prospective observational study was carried out at the King Hussein Cancer Centre (KHCC) in Amman, Jordan, between August 2009 and February 2012. The quality improvement project consisted of revising the institutional guidelines for surgical antimicrobial prophylaxis, assigning a clinical pharmacist to the surgical department, establishing an operating room satellite pharmacy and providing education regarding the appropriate utilisation of antibiotics. The medical records of adult cancer patients who underwent surgery were evaluated one month before and one month after the project was implemented to assess adherence to the guidelines with regards to antibiotics prescribed, drug doses and timing and treatment duration. RESULTS: A total of 70 patients were evaluated before and 97 patients were evaluated after the intervention, of which 57 (81.4%) and 95 (97.9%) patients received antibiotics, respectively. In comparing the pre- and post-intervention groups, an improvement was observed in the proportion of patients who received antibiotics at the appropriate time (n = 12 versus n = 79; 21.1% versus 83.2%; P <0.01), for the appropriate duration of time (n = 22 versus n = 94; 38.6% versus 99.0%; P <0.01) and in the appropriate dose (n = 9 versus n = 87; 56.3% versus 98.9%; P <0.01). CONCLUSION: Adherence to the antimicrobial prophylaxis guidelines at KHCC improved significantly after the implementation of a quality improvement project.

Histo-biological comparative analysis of bilateral breast cancer.

Bilateral breast cancer occurs in approximately 7% of surviving breast cancer patients. However, a dilemma exists concerning the notion of whether this represents a de novo second primary tumor versus a breast metastasis. We analyzed 81 patients with bilateral breast cancer, 47 (58%) synchronous tumors and 34 (42%) metachronous tumors. Additionally, charts were reviewed for age, family history, full histology data and biological receptors. We found there were no significant differences in concordance between the first and second primary tumors (in both synchronous and metachronous bilateral breast cancer) with respect to histology; grade; T-category; N-category; ER, PR and HER-2 status. In addition, there was no significant difference in the strength of correlation between ER and PR in the first and secondary primary tumors. Our findings suggest that the differentiation of the origin of contralateral breast cancer based on routine histological and biological concordance is inconclusive. Furthermore, the dilemma will continue to exist until additional molecular approaches are applied routinely for research purposes to resolve the debate.

How does preoperative radiotherapy affect the rate of sphincter-sparing surgery in rectal cancer?

The use of preoperative radiotherapy has resulted in significant downstaging and downsizing of tumor, this in turn facilitated resections permitting sphincter preservation and coloanal anastomosis for patients who would otherwise have not been candidates for this type of surgery as concluded by some small studies. On the other hand, other clinical trials have shown that the effect of radiotherapy on the rate of sphincter preservation is still not clear. Moreover, different modes of radiotherapy have been tested on the rate of sphincter preservation such as pelvic irradiation with or without combination of chemotherapy, short or conventional course radiotherapy, and preoperative or postoperative radiotherapy with different timing intervals of surgery. Unfortunately, these trials didn't clearly answer the question of radiotherapy benefit for the sake of sphincter preserving of rectal cancer patients and the question remained hotly debated.

Management strategies for locoregional recurrence in early-stage gastric cancer: retrospective analysis and comprehensive literature review.

OBJECTIVE: To present a comprehensive account and literature review addressing the anatomical distribution, natural history, and management strategies for locoregional recurrence in early-stage gastric cancer (EGC). PATIENTS AND METHODS: Retrospective chart review of patients presenting with EGC recurrence at King Hussein Cancer Center (Amman, Jordan) between July 2006 and May 2009. A literature review of publications addressing recurrence following surgery for EGC was undertaken via a systematic search of PUBMED database and National Comprehensive Cancer Network (NCCN) guideline updates. RESULTS: Seventeen patients presented with EGC, three of whom (17.6%) were pathologically staged as T2N1 [1/33 lymph nodes (LNs)], T1N0, and T1N0 were afflicted by recurrence following R0 partial gastrectomy. Literature review yielded 18 studies specifically addressing recurrence in EGC. Several management strategies have been proposed for isolated recurrence following gastrectomy in EGC. NCCN clinical practice guideline updates do not take into consideration whether the recurrence is isolated or widespread and whether the initial stage is early or advanced. CONCLUSIONS: While acknowledging the limitations of this study, including the small sample size and the short follow-up period, it appears clear that oncologic treatment is possible for EGC recurrence, particularly, in patients with isolated relapse. Guideline updates should differentiate between management strategies suitable for recurrence occurring in early versus advanced initial cancer stage.

Idiopathic retroperitoneal fibrosis of the pancreas versus pancreatic carcinoma.

We report one of few cases of idiopathic retroperitoneal fibrosis of the pancreas, which is different from the classical retroperitoneal fibrosis that affects ureters and vessels that mimicking locally advanced pancreatic carcinoma at presentation.

Long-term outcome of simple inversion of the appendix as an alternative to incidental appendectomy.

BACKGROUND: Inversion of the appendix is an alternative to incidental appendectomy to prevent future appendicitis. This study investigated outcome and complications in a group of patients who underwent simple inversion of the appendix. PATIENTS AND METHODS: Inversion of the appendix was performed in 41 patients, including 21 women (51%) and 20 men (49%) (mean age, 48.7 years; range, 12-85 years). A simple inversion technique was used in 65% of patients. Twenty-nine patients had colonoscopy between 3 to 44 months after surgery (mean, 8 months), none for the sake of the study. RESULTS: During the follow up, none of patients developed intussusception or rectal bleeding. Colonoscopy demonstrated an absent appendix in 9 patients (31%). In the remaining 20 patients (69%), the inverted appendix persisted with no obvious change on visualized mucosa. CONCLUSION: Neither intussusception nor hemorrhage was observed after simple inversion. In our view, persistence of the appendix is a welcome event since the presence of the appendix may carry several benefits as it continues to work as a specialized organ, exerting an important physiological role in facilitating forward passage of colon contents, providing antibacterial functions and possibly playing a preventive role against development of colon and other cancers.

Currarino triad associated with malrotation of the colon.

Currarino triad is a rare congenital condition characterized by a sacral bony defect, presacral mass, and anorectal malformations. We describe an unusual case of complete Currarino triad in a 22-year-old female with sacral bony defect, anal stenosis, recto-vaginal fistula, and dual pathology meningocele and teratoma in the pre sacral mass associated with malrotation of the colon. This combination has not been reported previously. The clinical presentation, surgical management and review of literature are discussed.

Branchial cyst: an often forgotten diagnosis.

OBJECTIVE: To study the clinical presentations, diagnosis and management of patients with the pathological diagnosis of branchial cysts. METHODS: This was a retrospective analysis of the records of 33 patients with the diagnosis of branchial cyst, seen between 1987 and 2003 at the General Surgical Unit of Jordan University Hospital. RESULTS: Thirty-four cases of branchial cysts were seen in 33 patients: 22 females and 11 males. There was a wide range in age (1-57 years), but the majority (25 patients) were in their second or third decades of life. Thirty-one cysts occurred in the classical site. The same number of branchial cysts occurred on the right and left sides of the neck (17 on the right and 17 on the left). Correct clinical diagnosis was made in only 14 cases (41.2%). CONCLUSION: Branchial cysts are frequently incorrectly diagnosed and forgotten in the differential diagnosis. Thus, the diagnosis is often delayed, resulting in the mismanagement of these patients. Branchial cyst should be suspected in any patient with a swelling in the lateral aspect of the neck, regardless of whether the swelling is solid or cystic, painful or painless. Fine needle aspiration cytology will accurately demonstrate the cystic nature. The presence of cholesterol crystals and/or epithelial cells in the aspirate will suggest the diagnosis of branchial cyst.