Phase II Clinical Trial of Intravenous Levothyroxine to Mitigate Pharyngocutaneous Fistula in Euthyroid Patients Undergoing Salvage Laryngectomy.

PURPOSE: Patients undergoing head and neck cancer surgery after prior radiation or chemoradiation are at high risk for wound complications. Hypothyroidism is a known risk factor for wound complications, especially fistulae after salvage total laryngectomy. The purpose of this phase II clinical trial is to investigate the effect of perioperative intravenous levothyroxine supplementation on wound complications in patients undergoing salvage total laryngectomy. PATIENTS AND METHODS: Euthyroid patients previously treated with radiation/chemoradiation undergoing total laryngectomy were prospectively recruited (n = 72). Postoperatively, intravenous levothyroxine was administered at a weight-based dose (1.3 mcg/kg/d) and transitioned to enteral dosing on day 7. Free T3, T4, and thyroid-stimulating hormones were collected, and dosing was adjusted accordingly. The primary endpoints were rates of fistula formation and fistula requiring reoperation, compared with matched historic controls. All patients were monitored for adverse effects. RESULTS: The rate of postoperative hypothyroidism was 21% compared with 49% in a matched historic cohort. The rate of fistula formation was 18.1%, whereas the rate of fistula requiring reoperation was 4.2%, significantly lower than rates in our historic cohort (34.6% and 14.8%, respectively; P = 0.02 and 0.01). Postoperative hypothyroidism and recurrent clinical stage predicted fistula requiring reoperation in multivariate analysis; other acute phase reactants were not predictive. There were no observed adverse events related to levothyroxine supplementation. CONCLUSIONS: Postoperative intravenous levothyroxine supplementation reduced rates of acute hypothyroidism, fistula formation, and fistula requiring reoperation in patients undergoing salvage total laryngectomy without adverse effects. Intravenous levothyroxine is a viable strategy to reduce wound complications in this high-risk patient population.

Horizontal pharyngeal closure during total laryngectomy reduces rates of pharyngocutaneous fistula.

PURPOSE: Pharyngocutaneous fistula (PCF) is a possible complication following total laryngectomy (TL), with a mean incidence of 17%. We intended to investigate the effect of pharyngeal closure type during TL on the prevention of PCF. METHODS: We retrospectively reviewed patients that underwent TL with a horizontal pharyngeal closure over a 10-year period. The frequency of PCF clinically, dysphagia, total oral diet, postoperative dilatation of the neopharynx and voice problems were tabulated. RESULTS: Seventy-seven subjects underwent TL due to laryngeal tumor without pharyngeal extension. Of them, 45 underwent a salvage TL. PCF occurred in 1/77 subjects. The rest of the subjects (76/77) did not develop a PCF, neither in the early nor in the late postoperative phase. All subjects (15/77) that underwent implantation of a voice prosthesis were satisfied with their voice. No subject complained about dysphagia. Every subject achieved total oral diet. CONCLUSION: The horizontal pharyngeal closure is a safe pharyngeal closure technique during TL, reduces PCF rates (< 2%), results in excellent voice rehabilitation and swallowing function, and can also be used during salvage TL instead of a major pectoral flap. This type of closure should be used only in selected patients with laryngeal disease without pharyngeal extension.

Vascularized Tissue to Reduce Fistula After Salvage Total Laryngectomy: A Network Meta-analysis.

OBJECTIVE: Salvage laryngectomy is more predisposed to complications than primary operations, with pharyngocutaneous fistula (PCF) being among the most challenging to manage. Vascularized flaps are increasingly employed during salvage laryngectomy, with a previous review finding a PCF incidence of 31.2% and 22.2% after primary and flap-assisted closure respectively. We aim to better define the role of vascularized flaps after salvage laryngectomy by performing an updated review comparing the rate of PCF in those undergoing primary or vascularized flap-assisted closure. DATA SOURCES: Pubmed/Medline, CINAHL, and CENTRAL. REVIEW METHODS: An updated literature review was conducted of English language literature from 2003 to 2023. A random effects and network meta-analysis of odds ratios (OR) and pooled proportions were conducted. RESULTS: Literature search found 31 studies, including seven from the previous review. Overall random effects pooled PCF rate was 25% (95% CI 0.21; 0.30, I2 = 72%, p = <0.01), whereas incidence in primary closure was 37% (95% CI 0.32; 0.43, I2 = 60%, p = <0.01) and 19% (95% CI 0.12; 0.20, I2 = 47%, p = <0.01) after flap closure. Pooled OR was 0.39 (95% CI 0.28; 0.55, I2 = 36%, p = 0.04) in favor of vascularized tissues. The number needed to treat was 6.5. The rate of PCF was lower after free and pedicled flaps, and on-lay and patch closure compared to primary closure techniques. Network meta-analysis found all combinations of closure techniques and vascularized tissue were superior to primary closure. CONCLUSION: The updated analysis has demonstrated a widening in the rates of PCF between primary and vascularized flap-assisted closure. Surgeons should strongly consider the use of free or pedicled flaps in any salvage laryngectomy procedure. Laryngoscope, 134:2991-3002, 2024.

Management and prevention of brachial plexus injury caused by surgical suture of neck dissection induced chylous fistula.

BACKGROUND: The complication of brachial plexus injury (BPI) after surgical suture of chylous fistula caused by neck dissection is extremely rare. For the first time, we investigated the treatment and prevention strategy of BPI caused by surgical suture of neck dissection induced chylous fistula. METHODS: Forty-two patients undergoing surgical suture of neck dissection induced chylous fistula were identified between January 2015 to March 2022 at a single tertiary academic center. All patients were divided into two groups, medial anterior scalene muscle (MASM) group (24 patients) and lateral anterior scalene muscle (LASM) group (18 patients), according to the location of fistula regarding scalene muscle described in the surgical records. The incidence of BPI between the two groups after surgical suture was summarized and compared. RESULTS: There was significant difference in the incidence of different degrees of BPI between the two groups. In the MASM group, the incidence of BPI was 0 % (0/24), while in the LASM group, 6 cases suffered different degrees of BPI immediately after operation and the incidence of BPI was 33.3 % (6/18) (p < 0.05). The neurological function of all BPI cases recovered within 1-3 months after the suture was removed in time. CONCLUSION: The incidence of BPI in patients of LASM group was significantly higher than that of MASM group. When suturing this kind of fistula, the depth of the needle should be properly controlled to avoid BPI. In case of BPI, the suture should be removed as soon as possible to promote the recovery of neurological function.

AGA technical review on the medical management of moderate to severe luminal and perianal fistulizing Crohn's disease

The incidence and prevalence of Crohn's disease (CD) is rising globally. Patients with moderate to severe CD are at high risk for needing surgery and hospitalization and for developing disease-related complications, corticosteroid dependence, and serious infections. Optimal management of outpatients with moderate to severe luminal and/or fistulizing (including perianal) CD often requires the use of immunomodulator (thiopurines, methotrexate) and/or biologic therapies, including tumor necrosis factor-α antagonists, vedolizumab, or ustekinumab, either as monotherapy or in combination (with immunomodulators) to mitigate these risks. Decisions about optimal drug therapy in moderate to severe CD are complex, with limited guidance on comparative efficacy and safety of different treatments, leading to considerable practice variability. Since the last iteration of these guidelines published in 2013, significant advances have been made in the field, including the regulatory approval of 2 new biologic agents, vedolizumab and ustekinumab. Therefore, the American Gastroenterological Association prioritized updating clinical guidelines on this topic. To inform the clinical guidelines, this technical review was completed in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. The review addressed the following focused questions (in adult outpatients with moderate to severe luminal CD): overall and comparative efficacy of different medications for induction and maintenance of remission in patients with or without prior exposure to tumor necrosis factor-α antagonists, comparative efficacy and safety of biologic monotherapy vs combination therapy with immunomodulators, comparative efficacy of a top-down (upfront use of biologics and/or immunomodulator therapy) vs step-up treatment strategy (acceleration to biologic and/or immunomodulator therapy only after failure of mesalamine), and the role of corticosteroids and mesalamine for induction and/or maintenance of remission. Finally, in adult outpatients with moderate to severe fistulizing CD, this review addressed the efficacy of pharmacologic interventions for achieving fistula and the role of adjunctive antibiotics without clear evidence of active infection.

[Injection of incobotulinum toxin A for the prevention of postoperative salivary fistula and sialocele]. / Primenenie botulotoksina tipa A v profilaktike posleoperatsionnykh slyunnykh svishchei i sialotsele.

The aim of the clinical study was to improve prevention of postoperative sialocele and fistulas of parotid glands. MATERIALS AND METHODS: The study included 100 patients with tumors of parotid glands treated by superficial parotidecthomy. Fifty patients received incobotulinum toxin A preoperatively, while control group consisted of 50 patients without preoperative injections. RESULTS: Salivary fistulas formed in 17% of cases in control group. Discharging of saliva through the postoperative wound for 6 days after surgical treatment were noticed in the control group in 30% of cases. There were no complications such as forming of salivary fistula and sialocele and no saliva flow from the postoperative wound on the 4th day after surgical treatment in the main group. Conclusion. The use of botulinum toxin type A proved an efficient and effective way for prevention of postoperative salivary fistulas and sialocele.

Prophylactic innominate artery transection to prevent tracheoinnominate artery fistula: a retrospective review of single institution experiences.

PURPOSE: This study aimed to investigate the optimal indication and availability of prophylactic innominate artery transection (PIAT). METHODS: We retrospectively analyzed the medical records of the patients with neurological or neuromuscular disorders (NMDs) who underwent PIAT. Meanwhile, we originally defined the tracheal flatting ratio (TFR) and mediastinum-thoracic anteroposterior ratio (MTR) from preoperative chest computed tomography imaging and compared these parameters between non-PIAT and PIAT group. RESULTS: There were 13 patients who underwent PIAT. The median age was 22 years. PIAT was planned before in one, simultaneously in five, and after tracheostomy or laryngotracheal separation in seven patients. Image evaluations of the brain to assess circle of Willis were performed in all patients. Appropriate skin incisions with sternotomy to expose the innominate artery were made in four patients. All patients are still alive except one late death without any association with PIAT. No neurological complications occurred in any patients. As significant differences (p < 0.01) between two groups were observed for TFR and MTR, objective validity of the indication of PIAT was found. CONCLUSIONS: PIAT is safe and tolerable in case of innominate artery compression of the trachea with NMDs. TFR and MTR are useful objective indexes to judge the indication of PIAT.

Risk Factors for Pharyngocutaneous Fistula After Total Pharyngolaryngectomy.

PURPOSE: To evaluate the risk factors of pharyngocutaneous fistula after total pharyngolaryngectomy (TPL) in order to reduce their incidence and propose a perioperative rehabilitation protocol. MATERIALS AND METHODS: This was a multicenter retrospective study based on 456 patients operated for squamous cell carcinoma by total laryngectomy or TPL. Sociodemographic, medical, surgical, carcinologic, and biological risk factors were studied. Reactive C protein was evaluated on post-op day 5. Patients were divided into a learning population and a validation population with patients who underwent surgery between 2006 and 2013 and between 2014 and 2016, respectively. A risk score of occurrence of salivary fistula was developed from the learning population data and then applied on the validation population (temporal validation). OBJECTIVE: To use a preoperative risk score in order to modify practices and reduce the incidence of pharyngocutaneous fistula. RESULTS: Four hundred fifty-six patients were included, 328 in the learning population and 128 in the validation population. The combination of active smoking over 20 pack-years, a history of cervical radiotherapy, mucosal closure in separate stitches instead of running sutures, and the placement of a pedicle flap instead of a free flap led to a maximum risk of post-op pharyngocutaneous fistula after TPL. The risk score was discriminant with an area under the receiver operating characteristic curve of 0.66 (95% confidence interval [CI] = 0.59-0.73) and 0.70 (95% CI = 0.60-0.81) for the learning population and the validation population, respectively. CONCLUSION: A preoperative risk score could be used to reduce the rate of pharyngocutaneous fistula after TPL by removing 1 or more of the 4 identified risk factors.

A cover flap reduces the rate of fistula after urethroplasty whatever the severity of hypospadias.

OBJECTIVE: To determine which patients should benefit from the interposition of a well-vascularized flap between the neourethra and the penile skin and if it should be performed even in mild hypospadias. PATIENTS AND METHODS: A retrospective study on patients with a primary hypospadias repair was performed (2003-2017). Only patients undergoing urethroplasty based on the principle of a tubularization were selected to ensure comparable groups. Patients were assigned in two groups according to the use or not of a cover flap. Univariate analysis and adjusted logistic regression were used to evaluate the relation between postoperative complications, the severity of hypospadias, the use of flap and patients' characteristics. RESULTS: Three-hundred and seventy-six patients were included with anterior (59.3%), midshaft (27.4%) and posterior hypospadias (13.3%). The median follow-up was 54 months (24 months-17 years). The overall rate of fistula was 11.7% (n = 44). Comparing the outcome in children with flap (n = 217) to controls (n = 159) showed that the use of a flap reduces the rate of fistula (6.5 vs 18.9%, p < 0.001). Stratification of the study according to the phenotype reveals that the more severe the hypospadias, the more protective was the flap (OR = 2.6 for anterior, 5.5 for midpenile, 7.1 for posterior hypospadias). The flap remains nevertheless significantly effective whatever the phenotype (p < 0.05 for anterior, p = 0.01 for midpenile, p = 0.02 for posterior hypospadias). CONCLUSIONS: The more severe the hypospadias, the more effective is the cover flap to avoid fistula. It remains nevertheless suitable even in anterior hypospadias and the use of a cover flap should not be limited to the surgery of severe phenotypes.

Application of acellular dermal matrix to reconstruct the defects after hypopharyngeal carcinoma resection.

PURPOSE: Reconstruction of the defects and recovery of the laryngopharyngeal function after resection of hypopharyngeal carcinoma are crucial for patients to promote the rate of survival and the quality of life. We launched this study to explore the advantages and limitations of acellular dermal matrix applied in the reconstruction of the defects after hypopharyngeal carcinoma surgery. MATERIALS AND METHODS: Collected the clinical and pathological data of patients with hypopharyngeal carcinoma, divided them into 2 groups according to the repair materials used (pectoralis major myocutaneous flap or acellular dermal matrix). The clinical data and postoperative complications were analyzed and compared. RESULTS: No matter whether the pectoralis major myocutaneous flap or acellular dermal matrix was used to repair hypopharyngeal cancer resection defects, the postoperative complications, especially the pharyngeal fistula rate, were not significantly different. The postoperative drainage volume of patients with acellular dermal matrix was less than that of patients with pectoralis major myocutaneous flap. CONCLUSIONS: Acellular dermal matrix is a safe and effective biomedical material for hypopharyngeal cancer operation defects repair and pharyngeal function reconstruction, which can simplify the operation process, reduce the postoperative drainage volume, and decrease the risk of wound infection or pharyngeal fistula.

Effect of collagen matrix on postoperative palatal fistula in cleft palate repair.

Palatal fistula is a challenging complication following cleft palate repair. We investigated the usefulness of collagen matrix in the prevention of postoperative fistula. We performed a retrospective cohort study of patients with cleft palate who underwent primary palatoplasty (Furlow's double opposing z-plasty) in Seoul National University Children's Hospital. Collagen Graft and Collagen Membrane (Genoss, Suwon, Republic of Korea) were selectively used in patients who failed complete two-layer closure. The effect of collagen matrix on fistula formation was evaluated according to palatal ratio (cleft width to total palatal width) and cleft width. A total of 244 patients (male, 92 and female, 152; median age, 18 months) were analyzed. The average cleft width was 7.0 mm, and the average palatal ratio was 0.21. The overall fistula rate was 3.6% (9/244). Palatal ratio (p = 0.014) and cleft width (p = 0.004) were independent factors impacting the incidence of postoperative fistula. Receiver operating characteristic curve analysis showed that the cutoff values in terms of screening for developing postoperative fistula were a palatal ratio of 0.285 and a cleft width of 9.25 mm. Among nonsyndromic patients with values above those cutoffs, the rates of fistula development were 0/5, 1/6 (16.7%), and 4/22 (18.2%) for those who received Collagen Graft, Collagen Membrane, and no collagen, respectively. Collagen matrix may serve as an effective tool for the prevention of palatal fistula when complete two-layer closure fails, especially in wide palatal clefts. The benefit was most evident in Collagen Graft with thick and porous structure.

Use of fibrin adhesive for preventing pharyngocutaneous fistula in total laryngectomy.

BACKGROUND: Minimizing pharyngocutaneous fistula after total laryngectomy is a perpetual focus for head and neck surgeons. Multiple intrinsic and extrinsic factors have been implicated in the wound healing process. Activated fibrin glue uniquely promotes healing as a tissue adhesive as well as a biochemical growth factor. METHODS: We present a pilot case series of total laryngectomy with simple pharyngeal closure with a single surgeon. Fibrin tissue adhesive was incorporated in all patients along with standardized pre-operative, operative, and post-operative care. Outcomes measured included pharyngocutaneous fistula rate, perioperative complications, and other wound complications as well as long term swallowing function and voice rehab outcomes. We also present a review of the literature for the theoretical basis of using fibrin glue as well as other similar applications. RESULTS: Fibrin tissue adhesive was successfully used in 18 consecutive patients undergoing total laryngectomy and pharyngoplasty. Despite the presence of a variety of wound healing risk factors including prior radiation and tobacco use, there were no pharyngocutaneous fistulas or other significant wound problems. No locoregional or free tissue overlay flap was done. CONCLUSION: Fibrin tissue glue is a readily available, easily applied, and cost-effective adjunct that may reduce pharyngocutaneous fistula.

Local Complications of Breast Surgery during Pregnancy and Lactation.

During pregnancy and lactation, breast vascularity increases and edema occurs in the breast . As a consequence, rate of complications of breast biopsy and surgery like bleeding, infection, delayed healing and wound dehiscence is expected to be higher. Milk fistula is a rare event that may complicate surgery or needle biopsy of the breast in a breastfeeding woman, or in late stages of pregnancy . Suppression of lactation has been proposed in the literature as both a preventive and a therapeutic step. However, the advantages of nursing for both mother and child are numerous, and the author do not propose it as a preventive measure nor as a must in treatment of milk fistula. Prevention and management of milk fistula are discussed in this chapter.

Feasibility of Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching to Reduce Fistula Incidence following Cleft Palate Repair: A Pilot Trial.

BACKGROUND: Improving surgeons' technical performance may reduce their frequency of postoperative complications. The authors conducted a pilot trial to evaluate the feasibility of a surgeon-delivered audit and feedback intervention incorporating peer surgical coaching on technical performance among surgeons performing cleft palate repair, in advance of a future effectiveness trial. METHODS: A nonrandomized, two-arm, unblinded pilot trial enrolled surgeons performing cleft palate repair. Participants completed a baseline audit of fistula incidence. Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique. All others were allocated to simple feedback (receiving audit results). Outcomes assessed were proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention. RESULTS: Seven surgeons enrolled in the trial. All seven completed the baseline audit and disclosed their fistula incidence to other participants. The median baseline fistula incidence was 0.4 percent (range, 0 to 10.5 percent). Two surgeons were unable to receive the feedback intervention. Of the five remaining surgeons, two were allocated to intensive feedback and three to simple feedback. All surgeons completed their assigned feedback intervention. Among surgeons receiving intensive feedback, fistula incidence was 5.9 percent at baseline and 0.0 percent following feedback (adjusted OR, 0.98; 95 percent CI, 0.44 to 2.17). CONCLUSION: Surgeon-delivered audit and feedback incorporating peer coaching on technical performance was feasible for surgeons.

Utility of the Montgomery salivary tubes for preventing pharyngocutaneous fistula in total laryngectomy.

PURPOSE: To evaluate the prophylactic, protocolized, and standardized use of a Montgomery tube in preventing pharyngocutaneous fistulas after total laryngectomy and neck dissection. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary referral centre. SUBJECT AND METHODS: A Montgomery salivary bypass tube was placed in 44 patients undergoing total laryngectomy and neck dissection, observing the percentage of fistula appearance and the time of start of deglutition. Comparison was made with a group of 28 patients prior to the implantation of the protocol in whom the tube was not used. RESULTS: There was a statistically significant decrease in the percentage of fistulas and an earlier onset of deglutition in the salivary bypass tube patients compared to those in whom the tube had not been used. CONCLUSION: Prophylactic and standardized use of the Montgomery salivary bypass tube in patients undergoing total laryngectomy and neck dissection might decrease the incidence of pharyngocutaneous fistula and improve the course of one that is already established.

Intraoperative application of inactivated Pseudomonas aeruginosa in patients undergoing lateral neck dissection for metastatic thyroid cancer: A randomized, parallel group, placebo-controlled trial.

BACKGROUND: We hypothesize that the intraoperative, prophylactic application of Pseudomonas aeruginosa can decrease postoperative chylous fistula and enhance recovery after surgery in patients with thyroid cancer undergoing lateral neck lymph node dissection. METHOD: In this single-center trial, we assigned randomly 200 patients with thyroid cancer who had proven lateral lymph node metastasis to groups receiving either 2 mL Pseudomonas aeruginosa spray (Pseudomonas aeruginosa group) or 2 mL saline spray (control group) in the lateral cervical surgical field. The primary end points were the rate of chylous fistula, mean difference in the duration and volume of drainage fluid, days of postoperative hospital stay, and overall cost. The secondary end points included the red blood cell count and triglyceride level in the drainage, the white blood cell count in the blood, fever, local pain, development of a pleural effusion, and tumor recurrence. RESULTS: Patients treated with Pseudomonas aeruginosa had a decrease in macroscopic chylous fistula compared with controls (0 vs 6%, P = .025). There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05). No severe side effects of the Pseudomonas aeruginosa spray with respect to fever, pain, or pleural effusion were observed. Pseudomonas aeruginosa spraying did not affect postoperative recurrence of the thyroid cancer. CONCLUSION: Intraoperative spraying of inactivated Pseudomonas aeruginosa in the lateral neck compartment can decrease the development of chylous fistula and enhance postoperative recovery.