A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial.Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm.The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation.The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.
BACKGROUND:
Pilonidal sinus is a disease of young adult males. Although there are various hypothesis introduced for the disease, acquired theory is the most widely accepted. Management of the disease is complex because of higher incidence of post op infection, recurrence and poor wound healing.
AIM AND OBJECTIVES:
Our aim of this study is to compare the Rhomboid excision with Limberg flap versus Excision with primary closure in the treatment of uncomplicated sacrococcygeal pilonidal sinus disease in terms of morbidity, hospital stay, complications and recurrence rate.
METHODS:
This is a prospective study conducted on a 30 patients of pilonidal sinus who were admitted in Department of General surgery, Coimbatore medical college hospital for a period of 1 year from December 2017 to December 2018 after met with inclusion and exclusion criteria. They were subjected to surgical treatment, either by rhomboid excision and Limberg flap procedure (Group-A) or by excision and primary closure (Group-B). Operation time, early complications, postoperative day were recorded for both groups. Complete recovery time and late complications like delayed wound healing, hypertrophic scar and keloid after one month of surgery were recorded and long term follow up after 6 months were performed. Patients were also reviewed for recurrence
and patient satisfaction with the operation and scar formation. Then the two groups were compared. Data were analysed with SPSS software and chisquare and student t tests were applied. P<0.05 was considered as statistically significant.
RESULTS:
In our study, there was a male preponderance in a ratio of 3:1. Mean age at presentation is noted to be in the range of 28.47 ± 8.068 years. The disease was more common in persons having occupation of prolonged duration of sitting. Clinical presentations varied from pain, discharge to swelling in the midline sacrococcygeal region. The early post op complications, pain scores on
pod-1 and pod-4, day of pain free sitting and toileting were noted. All these patients were followed at one month and six months post surgery. There was a significant difference found between 2 groups in terms of pain free sitting and toileting, pain scores on pod-1 and pod-4, recurrence and patient satisfaction.
CONCLUSION:
Although limberg flap procedure has similar complications as excision with primary closure, it has a advantages of earlier return to physical activity, faster wound healing,lesser hospital stay, lower pain scores, less recurrence and good patient satisfaction. Therefore limberg flap procedure is best
recommended for the management of uncomplicated sacro-coccygeal pilonidal sinus disease.
A novel endoluminal fundoplication (ELF) technique using a trans‐oral and fastener‐deploying device (EsophyX™, EndoGastric Solutions) was developed and evaluated for feasibility, safety and the treatment of gastroesophageal reflux disease (GERD) in a series of bench, animal, human (phase 1, phase 2, commercial registry) studies. The studies verified biological compatibility, durability and non‐toxicity of the polypropylene fasteners as well as the feasibility of the ELF technique. The results of the preclinical testing indicated that the EsophyX™ device was shown to be safe, and capable of deploying fasteners directly into tissue and forming an interrupted suture line at the base of the gastro‐esophageal valve (GEV). Moreover, the studies demonstrated that the ELF technique performed using the EsophyX™ device resulted in the creation of new GEVs of 3–5 cm in length and a circumference of 200°–310°, which maintained their anatomical aspects at six months. The ELF‐created GEVs appeared similar to those created by laparoscopic anti‐reflux surgery (LARS). The ELF procedure also resulted in reduction of all small hiatal hernias (⩽2 cm in size) and restoration of the angle of His. The ELF procedure provides an anatomical approach similar to that of LARS for the treatment of GERD.
A feasibility study (n = 19) evaluated the safety and initial efficacy of transoral incisionless fundoplication (TIF) for the treatment of gastroesophageal disease (GERD). The results at 1 year (n = 17) indicated that TIF was safe and had a significant effect on reducing GERD symptoms, proton pump inhibitor (PPI) usage, acid exposure, and small hiatal hernia. This study was designed to evaluate the long-term safety and durability of TIF.Fourteen patients (50% female; median age, 34 years) completed the 2-year follow-up assessment tests. Three patients were excluded from the study after 1 year because two of them underwent retreatment and one was lost to follow-up.At 2 years, no adverse events related to TIF were reported. A >or=50% improvement in GERD-HRQL scores compared with those at baseline on PPIs was sustained by 64% of patients. TIF was effective in eliminating heartburn in 93% of patients and daily PPI therapy in 71% of patients. Significantly (p < 0.05) more patients were able to consume reflux-causing foods and maintain lifestyle activities without GERD symptoms compared with baseline on PPIs. Fundoplications were durable and maintained their geometric dimensions. TIF was effective in eliminating hiatal hernia in 60% of patients and esophagitis in 55% of patients. Global assessment of all outcomes in each patient revealed that 79% of patients experienced complete cure (29%) or remission (50%) of GERD at 2 years after TIF.The results at 2 years supported the long-term safety and durability of TIF and its sustained effect on the elimination of heartburn, esophagitis,
Background. To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. Methods. A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. Results. Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. Conclusions. The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.
Summary Background Until recently only two therapeutic options have been available to control symptoms and the esophagitis in chronic gastro‐oesophageal reflux disease ( GERD ), i.e. lifelong proton pump inhibitor ( PPI ) therapy or anti‐reflux surgery. Lately, transoral incisionless fundoplication ( TIF ) has been developed and found to offer a therapeutic alternative for these patients. Aim To perform a double‐blind sham‐controlled study in GERD patients who were chronic PPI users. Methods We studied patients with objectively confirmed GERD and persistent moderate to severe GERD symptoms without PPI therapy. Of 121 patients screened, we finally randomised 44 patients with 22 patients in each group. Those allocated to TIF had the TIF 2 procedure completed during general anaesthesia by the EsophyX device with SerosaFuse fasteners. The sham procedure consisted of upper GI endoscopy under general anaesthesia. Neither the patient nor the assessor was aware of the patients' group affiliation. The primary effectiveness endpoint was the proportion of patients in clinical remission after 6‐month follow‐up. Secondary outcomes were: PPI consumption, oesophageal acid exposure, reduction in Quality of Life in Reflux and Dyspepsia and Gastrointestinal Symptom Rating Scale scores and healing of reflux esophagitis. Results The time (average days) in remission offered by the TIF 2 procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P < 0.001. After 6 months 13/22 (59%) of the chronic GERD patients remained in clinical remission after the active intervention. Likewise, the secondary outcome measures were all in favour of the TIF 2 procedure. No safety issues were raised. Conclusion Transoral incisionless fundoplication ( TIF 2) is effective in chronic PPI ‐dependent GERD patients when followed up for 6 months. Clinicaltrials.gov: CT01110811
