Incidence of persistent SARS-CoV-2 gut infection in patients with a history of COVID-19: Insights from endoscopic examination.

Background and study aims Gut infection is common during acute COVID-19, and persistent SARS-CoV-2 gut infection has been reported months after the initial infection, potentially linked to long-COVID syndrome. This study tested the incidence of persistent gut infection in patients with a history of COVID-19 undergoing endoscopic examination. Patients and methods Endoscopic biopsies were prospectively collected from patients with previous COVID-19 infection undergoing upper or lower gastrointestinal endoscopy (UGE or LGE). Immunohistochemistry was used to detect the presence of persistent SARS-CoV-2 nucleocapsid proteins. Results A total of 166 UGEs and 83 LGE were analyzed. No significant differences were observed between patients with positive and negative immunostaining regarding the number of previous COVID-19 infections, time since the last infection, symptoms, or vaccination status. The incidence of positive immunostaining was significantly higher in UGE biopsies than in LGE biopsies (37.34% vs. 16.87%, P =0.002). Smokers showed a significantly higher incidence of positive immunostaining in the overall cohort and UGE and LGE subgroups ( P <0.001). Diabetic patients exhibited a significantly higher incidence in the overall cohort ( P =0.002) and UGE subgroup ( P =0.022), with a similar trend observed in the LGE subgroup ( P =0.055). Conclusions Gut mucosal tissues can act as a long-term reservoir for SARS-CoV-2, retaining viral particles for months following the primary COVID-19 infection. Smokers and individuals with diabetes may be at an increased risk of persistent viral gut infection. These findings provide insights into the dynamics of SARS-CoV-2 infection in the gut and have implications for further research.

To assess the aggressiveness of oral squamous cell carcinoma in the young population.

Objectives: To assess the recurrence and disease-free survival in oral squamous cell carcinoma patients, and to compare them between two age groups. METHODS: Data were extracted from Patel hospital cancer registry database of patients admitted from January 1st2008 to December 31st 2018 based on retrospective diagnosed with oral squamous cell carcinoma. Patient stratified in to two groups i.e. patients with less than or more than 40 years. Various etiological factors, staging, treatment, site of the tumor and recurrence and mortality were assessed. RESULTS: Of the 450 patients, 124(27.5%) were in group A and 327(72.5%) were in group B. There were 101(81%) males in group A and 240(73.4%) males in group B. The overall mean age was 43.63±10.75 years (range: 22-70 years). The most common site of the tumour was cheek 232(51.5%). Recurrence of tumour was 45(36%) in group A and 120(37%) in group B (p=0.653). Overall mortality in group A was 67(54%) compared to 168(51%) in group B (p=0.811). CONCLUSIONS: Mortality and disease recurrence in both age groups was almost the same. Cheek was the most common site of presentation.

Risk factors associated with disease recurrence in patients with T4 staged Squamous Cell Carcinoma of the Oral Cavity treated with surgery and postoperative radiotherapy.

Objective: To determine the association of clinical and pathological parameters on recurrence of treated stage T4squamous cell carcinoma of oral cavity patients managed with surgery followed by concomitant chemo and radiation therapy. METHODS: The retrospective, cohort study was conducted at Patel Hospital, Karachi, and comprised data of patients diagnosed with oral squamous cell carcinoma and admitted between January 1, 2014, and January 30, 2019. Patients of either gender aged 20-80 years who had a minimum follow-up of one year were included. Data was collected using the Head and Neck Cancer registry form and the medical record files. The subjects were also contacted by telephone when needed. The study end-points were disease-free survival and overall survival. Data was analysed using SPSS 21. RESULTS: Out of the 83 patients, 65(78%) were male. The overall median(range) age was 46(20-80) years, and 43(52%) of them were aged 31-50 years. Overall, 15(18%) patients had positive margins and 48(58%) had proven cervical node metastasis on histopathology. Overall survival was 42.2% with the median(range) follow-up time was 14(9-21) months and 5-year disease-free survival was 45.8% with the median (range) follow-up time was 13(7-19). The factor that affected the final outcome was found to be the increasing nodal ratio (p=0.043). Conclusion: Among T4 oral squamous cell carcinoma patients treated with surgery and adjuvant therapy, the rate of disease recurrence was found to be high. Tumours with a high cervical nodal disease burden and/or margin involved were at substantially higher risk of recurrence.

Role of contrast enhanced computed tomography in assessing cervical lymph node metastases in oral cavity squamous cell carcinoma.

OBJECTIVE: To evaluate the diagnostic accuracy of contrast-enhanced computed tomography scan in detecting cervical nodal metastasis in oral cavity squamous cell carcinoma. METHODS: The retrospective cross-sectional study was conducted at Aga Khan University Hospital, Karachi, Pakistan. and comprised records from January 1, 2015, to October 31, 2016, of patients diagnosed with oral cavity squamous cell carcinoma and who underwent surgical resection of primary tumour along with neck dissection after having a contrast-enhanced computed tomography scan of head and neck. Diagnostic accuracy of the scans was calculated using final histopathology as the gold standard. All scans were reviewed by a consultant radiologist. Data was analysed using SPSS 23. RESULTS: Of the 100 patients whose records were reviewed, 70(70%) were female, 55(55%) had buccal and 32(32%) had tongue cancer.. The scans had sensitivity 83%, specificity 61.7%, positive predictive value 70.9%, negative predictive value 76.3% and overall diagnostic accuracy 73%. CONCLUSIONS: Computed tomography scan was found to be a useful tool for preoperative staging of oral cavity squamous cell carcinoma. However, due to low specificity and negative predictive value, elective neck dissection should still be done in a negative scan for cervical lymph node metastases.

A rare case of three years disease free survival in a locally advanced parathyroid carcinoma successfully excised by complete surgical resection.

Parathyroid carcinoma (PC) is one of the rarest malignancies making approximately 0.005% of all cancers. It may arise sporadically or less commonly, in conjunction with genetic endocrine syndromes. Due to the rarity of the disease, no general consensus or definitive guidelines exist for its pre-operative diagnosis, management, or follow up. Surgical tumor removal is the gold standard treatment to prevent its recurrence. Parathyroid carcinoma has a high recurrence rate ranging from 40 to 60% in recent literature. We report a case of a seventy-year-old elderly female with locally advanced parathyroid carcinoma successfully surgically excised completely with a 3 year disease free survival period without adjuvant chemotherapy or radiotherapy.

Weight Loss and Diabetes Control Following Laparoscopic Sleeve Gastrectomy.

Background: Data following laparoscopic sleeve gastrectomy (LSG) for type 2 diabetes mellitus obese patients are extremely variable and we herein present our results. Methods: The data of 320 (90 diabetic) obese patients who had LSG were retrieved from prospectively collected database. Postoperative weight loss and glycemic control were evaluated during 24 months follow-up. Results: Diabetic patients had a significantly higher percentage excess weight loss (%EWL) (60.21 ± 11 and 72.9 ± 13) than nondiabetics (53.4 ± 12 and 62.5 ± 29) at 12 and 24 months post LSG, respectively. Diabetic patients with body mass index (BMI) >40 kg/m2 had significantly higher %EWL (64.17 ± 13 and 75.2 ± 16) than patients with BMI ≤40 at 12 and 24 months, respectively. The mean glycated hemoglobin and fasting blood glucose were 6.6% ± 1.4%, 6.1% ± 1.1%, 5.9% ± 1.2%, 5.8% ± 0.5%, and 110 ± 1.6 mg/dL, 106.7 ± 1.8 mg/dL, 99.2 ± 1.9 mg/dL, and 98.1 ± 1.2 mg/dL at 1, 6, 12, and 24 months, respectively. All patients had complete diabetes remission at 12 months, and this was maintained at 24 months. Conclusion: Diabetic obese patients with BMI >40 kg/m2, had a better %EWL compared with nondiabetics and to diabetics with lower BMI. Diabetes remission started early at 1 month. At 12 months, all diabetics had complete diabetes remission and this was maintained at 24 months. Our results need to be validated in a larger study, which evaluates impact of gastrointestinal motility on diabetes control.

Laparoscopic versus open appendectomy for perforated appendicitis in adults: randomized clinical trial.

BACKGROUND: The advantages of laparoscopic appendectomy did not meet the same acceptance in the setting of perforated appendicitis as in uncomplicated appendicitis in the general surgical community. The aim of this study was to compare the clinical outcome of laparoscopic and open appendectomy in perforating appendicitis. METHODS: A randomized controlled study was conducted on 126 patients presenting with perforated appendicitis. Sixty patients were subjected to laparoscopic appendectomy (LA) and 66 patients underwent traditional open appendectomy (OA). RESULTS: 65 (51.6%) patients were female, and 61 (48.4%) patients were male in whom the mean age was 37.6 + 8.5 years. A significant difference was calculated in the domains of postoperative pain, less need for analgesics, hospital stay, and return to daily activities. The mean operative time was shorter in OA 94 ± 10.4 min than LA 120.6 ± 17.7 min. No statistically significant difference between both groups was detected as regard occurrence of intra-abdominal collection. CONCLUSION: In view of its clinical outcomes, laparoscopy should be considered in the context of perforated appendicitis. The possibility of intra-abdominal collection should not be a barrier against the widespread practice of this surgical procedure amidst laparoscopic surgeons if adequate precautions are employed.

Cholelithiasis after bariatric surgery, incidence, and prophylaxis: randomized controlled trial.

BACKGROUND: Rapid weight loss is associated with a high incidence of cholelithiasis. OBJECTIVES: To identify the incidence of gallstone formation after weight loss surgery and to detect the efficacy of 6 months regimen of prophylactic Ursodeoxycholic acid (UDCA). METHODS: RCT included a total of 1530 morbid obese patients who were subjected to either laparoscopic one anastomosis gastric bypass (OAGB), sleeve gastrectomy (SG), or greater curve plication (GCP). Patients with previous or concomitant cholecystectomy and missed follow-up were excluded, leaving 1432 patients to analyze. They were randomly allocated into two groups receiving either UDCA or placebo with a minimum follow-up of one year for assessment of cholelithiasis and weight loss. RESULTS: The overall incidence of cholelithiasis after surgery was 9.7%. There was a significant decrease in the incidence of gallstone formation from 22% in placebo to 6.5% in treated group with UDCA. The mean percentage of excess weight loss (%EWL) was significantly higher in those who develop gallstones than others. Of those developing gallstones, there was 64.7 % with SG versus 28.1% and 7.2% in OAGB and GCP, respectively, which is statistically significant. NNT to prevent cholelithiasis is six, AR% is 70.4%, and RR is 3.4%. CONCLUSIONS: Cholelithiasis after SG and OAGB was higher than GCP. %EWL was rapid and higher in OAGB and SG contributing to the higher rate of symptomatic cholelithiasis and could be predictive for post-bariatric cholelithiasis. A 6-month use of UDCA is an effective prophylaxis decreasing gallstone formation after bariatric surgery at short-term follow-up.

Impact of Laparoscopic Sleeve Gastrectomy on Obese Patients with Subclinical Hypothyroidism.

Background: This study aims to evaluate the incidence of subclinical hypothyroidism (SCH) among studied obese patients. The effects of laparoscopic sleeve gastrectomy (LSG) and loss of weight on thyroid hormones level and the impact of adding thyroxine treatment is described. Patients and Methods: Obese patients undergoing LSG at the university hospital between June 2016 and January 2018 were included. Weight loss and changes in body mass index (BMI), serum thyroid stimulating hormone (TSH), and FT4 were evaluated. SCH patients were randomly divided into group "A" received thyroxine treatment and group "B" received no treatment. Results: There were 554 patients studied (mean age 41 ± 12 years); the mean preoperative BMI, serum TSH, and FT4 were 45 ± 6.8 kg/m2, 3.91 ± 1 µU/mL, and 1.32 ± 1 ng, respectively. Incidence of SCH was 12.9%. Significant post-LSG decrease in BMI (30.8 ± 4.6 kg/m2) was associated with significant decrease in serum TSH (1.99 ± 1.1 µU/mL) in all patients; changes were more prominent in SCH group and in patients with higher BMI. SCH patients had normalization of mean serum TSH at 12 months post-LSG. Results of groups "A" and "B" were not significantly different. Conclusion: The incidence of SCH was 12.9%. The significant decrease in BMI was associated with a significant decrease in serum TSH after LSG; this was more evident in SCH and in patients with higher BMI. Complete resolution of SCH occurred at 12 months post-LSG. Adding thyroxine treatment in obese SCH patients did not improve outcome and should be reserved to specific clinical and laboratory indications.

Calcifying fibrous pseudotumour of maxilla: A rare entity mimicking malignancy: A case report.

Occurrence of inflammatory pseudotumour in head and neck region or nose and paranasal sinuses is rare. However, when they do occur, they could be quite aggressive. Etiologically, they are believed to be reactive than neoplastic, and calcification may suggest end-stage. Their clinical presentation and radiologic features may resemble a malignancy. Grossly, they are not encapsulated, but multilobulated and can be circumscribed or infiltrative. Histologically, they constitute of bland spindle cells with scant cytoplasm and occasional mitotic figures. Scattered lymphocytic and plasma cell infiltrates with abundant dense hyalinized collagenous stroma and focal small calcifications are seen. Presence of atypia, DNA aneuploidy, and abnormal p53 expression may suggest malignant potential. Though not known to metastasize, they can lead to local complications, causing destruction of bone and surrounding tissues. Management is mainly by surgical excision though adjunct corticosteroids have been advocated. We report such a rare case of calcifying fibrous pseudotumour of maxilla.

Laparoscopic Nissen Fundoplication Plus Mid-gastric Plication for Treatment of Obese Patients with Gastroesophageal Reflux Disease.

BACKGROUND: Gastroesophageal reflux disease (GERD) is commonly associated with obesity, and its surgical management is debatable. OBJECTIVE: The objective of this study was to prove the safety and feasibility of laparoscopic Nissen's fundoplication (LNF) combined with mid-gastric plication (MGP) for treatment of obese patients with GERD. METHODS: LNF combined with MGP was done for 18 patients. All interventions were performed under general anesthesia. The follow-up protocol included body mass index (BMI), percentage of excess weight loss (%EWL), percentage of excess BMI loss (%EBMIL), and clinical assessment using the Gastro-esophageal Reflux Health-Related Quality-of-Life (GERD-HRQOL) scale at 6 and 12 months. RESULTS: The period of follow-up ranged from 12 to 33 months with a mean of 17.74 ± 3.73 months. The operation time was 1.40 ± 0.27 h. No serious procedure-related complications occurred. GERD-related symptoms resolved in all patients (p < 0.001). There was a significant improvment in endoscopic findings at 6 months compared to properatively (p = 0.001). There was a significant patient satisfaction score using GERD-HRQOL at 6 and 12 months (p = 0.000). The 1-year follow-up excess weight was significantly less than the baseline excess weight (p < 0.001). The average BMI decreased from 37.59 ± 1.89 kg/m2 at baseline to 30.61 ± 1.57 kg/m2 at 1 year (p < 0.001). CONCLUSIONS: LNF combined with MGP for treatment of obese patients with GERD is technically safe, feasible, and promising with no serious procedure-related complications. The technique is effective in terms of weight loss and cure of GERD. However, future larger studies are required to demonstrate the safety, effectiveness, and long-term durability of the procedure.

Effects of bomb blast injury on the ears: The Aga Khan University Hospital experience.

OBJECTIVE: To evaluate the frequency and effects of blast-related otologic injuries. METHODS: his retrospective study was conducted at the Aga Khan University Hospital, Karachi, and comprised charts of patients who were victims of bomb explosions between January 2011 and July 2013. Frequency and percentages were reported using cross tabulation with size of bomb, distance of person from blast and the presence of victim in open or closed space. Association of associated variables were also analysed. RESULTS: Of the 100 patients, 81(81%) were men and 19(19%) were women. Besides, 68(68%) patients were aged <30 years. Also, 78(78%) subjects were exposed to < 80kg of explosives and 68(68%) were at a distance of>10m. Furthermore, 61(61%) patients were exposed to explosion in openspace. The prevalence of ear injuries was 21(21%). The odds of experiencing various symptoms of ears was high in those who were exposed to >80 kg of explosives (odds ratio: 3.38; 95% confidence interval, 1.16, 9.91). The odds of hearing loss in those who were within 10m was 8.62 (95% confidence interval: 2.72, 27.28) times than those who were >10 m from the site of explosion. CONCLUSIONS: Otologic injuries were frequently associated with large blasts.

Effectiveness of plain X-ray in detection of fish and chicken bone foreign body in upper aerodigestive tract.

OBJECTIVE: To assess the use of plain film radiology in the detection of fish and chicken bones in the upper aerodigestive tract. METHODS: This retrospective chart review was conducted at the Aga Khan University Hospital, Karachi, and comprised medical charts of patients who had undergone oesophagoscopy for removal of fish and chicken bone from 1990 to 2015.SPSS 19 was used for data analysis. RESULTS: Of the 24 patients, foreign body was detected on X-ray in 7(29.2%) and through fibre optic laryngoscopy in 13(54.2%).All the patients underwent surgical intervention for removal of the foreign body. Also, 19(79.2%) patients underwent direct laryngoscopy and 5(16.7%) required oesophagoscopy. The sensitivity with X-ray was 15% and specificity was zero. The sensitivity of fibre optic laryngoscopy in comparison to intra-operative findings was 65% and the specificity was 100%. CONCLUSIONS: X-ray was not found to be an ideal modality to diagnose fish or chicken bone impaction in the upper aerodigestive tract.

Ligasure, Harmonic Scalpel versus conventional diathermy in excisional haemorrhoidectomy: a randomized controlled trial.

BACKGROUND: This study was designed to compare the surgical outcomes of haemorrhoidectomy performed by the Ligasure, Harmonic Scalpel with that performed by the conventional diathermy. METHODS: A total of 180 patients were randomized to Ligasure, Harmonic Scalpel and diathermy haemorrhoidectomy, 60 patients for each group. The operative time, post-operative pain scores, parenteral analgesic requirements in the first 24 h, post-operative complications and wound healing rates were documented. RESULTS: The median operative time was 8 min (range, 7-18) for the Ligasure and Harmonic Scalpel groups and 18 min (range, 15-21) for the diathermy group (P < 0.001). Throughout the first post-operative week, the daily median pain score was lower in the Ligasure and Harmonic Scalpel groups than in the diathermy group (P < 0.001). The median number of analgesic ampoules during the first 24 h post-operatively was lower in the Ligasure and Harmonic Scalpel groups (P < 0.001). There was no statistically significant difference in the incidence of post-operative complications. At 6 weeks post-operation, more patients in the Ligasure and Harmonic Scalpel groups had complete healing of wounds (P = 0 < 0.001). CONCLUSION: Ligasure and Harmonic Scalpel provide a superior alternative to conventional diathermy in haemorrhoidectomy with no difference between them in reducing the operative time, post-operative pain, analgesic requirements during the first 24 h and time to complete healing of wounds.

Frequency of Sensorineural hearing loss in chronic suppurative otitis media.

Chronic suppurative otitis media (CSOM) is defined as chronic otorrhea (i.e., lasting > 6-12 weeks) through a perforated tympanic membrane. It is generally associated with some degree of conductive hearing loss. However, recurrent ear infections due to perforated eardrum result in absorption of toxins and macromolecules into the cochlea leading to sensorineural hearing loss (SNHL). We planned to determine the frequency of sensorineural hearing loss in chronic suppurative otitis media. A descriptive cross-sectional study was conducted at Aga Kgan University Hospital, Karachi, from October 2013 to March 2014. Average threshold of speech frequencies was calculated via pure tone audiogram for both diseased and normal contralateral ear.A mean of >25db in diseased ear was labelled as positive case for SNHL. SNHL was reported in 64(52%) patients and the frequency was found to increase with increasing duration. Patients with CSOM should be counselled regarding the risk of developing SNHL if left untreated.

Is There Any Benefit of Drain Placement on Postoperative Complications in Patients Undergoing the Sistrunk Procedure?

Introduction Same-day, outpatient Sistrunk procedure is commonly performed to manage thyroglossal duct cyst anomalies and may lead to postoperative complications. Surgical drains are placed to prevent complications, but recent observations show no advantage and rather increased health care costs and patient discomfort. Objective The study evaluated if drain placement in the Sistrunk procedure offers any benefit on postoperative complications. Methods A retrospective analysis of patient records having undergone same-day, outpatient Sistrunk procedure from 2004 to 2014 was done. Of 58 (38 male and 20 female) patients included, 38 did not have drains placed and the remaining 20 had drains placed. Mean and median age of patients was 18.1 and 13.5 years, respectively. Postoperative complications of patients with drains versus those without drains were statistically analyzed. Results Overall, about 10% of patients had hematoma/seroma (H-S), with 6.9% of patients needing aspiration for H-S; 3.4% had wound infections; and 1.7% had pus formation. No statistically significant differences in Sistrunk-related complications between patient groups (with drain or without drain) were seen using Fisher exact (two-sided) test: H-S (p = 0.08); need for aspiration (p = 0.29); wound infection (p > 0.05); and pus formation (p = 0.35). Chi-square test also did not show any significant difference in the groups in terms of number of follow-ups. Conclusion Surgical placement of a drain in the Sistrunk procedure does not seem to offer any advantage in terms of reducing common postoperative complications. Sameday Sistrunk procedure without any drain placement may be a safer alternative without necessitating hospitalization. More studies with larger sample size are needed for further substantiation.(AU)

Is There Any Benefit of Drain Placement on Postoperative Complications in Patients Undergoing the Sistrunk Procedure?

Introduction Same-day, outpatient Sistrunk procedure is commonly performed to manage thyroglossal duct cyst anomalies and may lead to postoperative complications. Surgical drains are placed to prevent complications, but recent observations show no advantage and rather increased health care costs and patient discomfort. Objective The study evaluated if drain placement in the Sistrunk procedure offers any benefit on postoperative complications. Methods A retrospective analysis of patient records having undergone same-day, outpatient Sistrunk procedure from 2004 to 2014 was done. Of 58 (38 male and 20 female) patients included, 38 did not have drains placed and the remaining 20 had drains placed. Mean and median age of patients was 18.1 and 13.5 years, respectively. Postoperative complications of patients with drains versus those without drains were statistically analyzed. Results Overall, about 10% of patients had hematoma/seroma (H-S), with 6.9% of patients needing aspiration for H-S; 3.4% had wound infections; and 1.7% had pus formation. No statistically significant differences in Sistrunk-related complications between patient groups (with drain or without drain) were seen using Fisher exact (two-sided) test: H-S (p = 0.08); need for aspiration (p = 0.29); wound infection (p > 0.05); and pus formation (p = 0.35). Chi-square test also did not show any significant difference in the groups in terms of number of follow-ups. Conclusion Surgical placement of a drain in the Sistrunk procedure does not seem to offer any advantage in terms of reducing common postoperative complications. Same-day Sistrunk procedure without any drain placement may be a safer alternative without necessitating hospitalization. More studies with larger sample size are needed for further substantiation.

Gastroesophageal reflux disease and esophageal motility in morbidly obese patients submitted to laparoscopic adjustable silicone gastric banding or laparoscopic vertical banded gastroplasty.

BACKGROUND: Laparoscopic adjustable silicone gastric banding (LASGB) and laparoscopic vertical banded gastroplasty (LVBG) are the most frequently performed restrictive operations for morbid obesity. The question of whether bariatric restrictive procedures increase or reduce gastroesophageal reflux disease (GERD) remains open. This study aimed to compare the long-term results of LASGB with those of LVBG in terms of postoperative GERD and esophageal motility function. METHODS: From February 1999 to December 2000, 175 patients underwent bariatric surgery. After 75 of these patients were excluded from the study, the remaining 100 patients were randomly assigned to one of two treatment groups: LASGB or LVBG. The end points of the study were evaluation of clinical and instrumental GERD and esophageal function. The follow-up protocol included clinical assessment using the Gastroesophageal Reflux Health-Related Quality-of-Life (GERD-HRQOL) scale at 3, 12, and 96 months. Esophageal manometry, 24-h pH monitoring, and endoscopy were performed at 12 and 96 months. RESULTS: At 12 months, GERD had developed in 13 (26%) LASGB and 11 (21.6%) LVBG patients. In the majority of cases, GERD resulted from pouch dilation or poor compliance and required either reoperation (ten after LASGB and three after LVBG) or endoscopic dilation of the neopylorus (four after LVBG). In all, 71 patients completed the 96-month follow-up protocol. The findings showed that three (11.5%) of 26 LASGB patients and four (9%) of 45 LVBG patients were receiving proton pump inhibitor (PPI) therapy for GERD. Postoperative lower esophageal sphincter (LES) pressure and esophageal motility did not differ from preoperative data except for the presence of aperistaltic waves in one LASGB and two LVBG symptomatic GERD patients. CONCLUSIONS: No significant association between gastric restrictive procedures and GERD or esophageal function was found during long-term follow-up assessment. The increased occurrence of GERD in the early follow-up period often is due to a technical defect or poor patient compliance.