Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial

BACKGROUND: A totally transoral outpatient procedure for the treatment of GERD would be appealing. METHODS: A multicenter trial was initiated that included 64 patients with GERD treated with an endoscopic suturing device. Inclusion criteria were 3 or more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Patients underwent manometry, endoscopy, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patients were randomized to a linear or circumferential plication configuration. Adverse procedural events were recorded. RESULTS: Mean 6-month symptom score changes demonstrated procedural efficacy. Heartburn severity and frequency as well as regurgitation all improved (p > 0.0001 for each). Twenty-four-hour pH monitoring showed improvement in number of episodes below pH of 4 at 3 and 6 months (p < 0.0007 and 0.0002) and percentage of total time the pH was less than 4 at 6 months (p < 0.011). Plication configuration did not affect symptoms or pH monitoring results. One patient had a self-contained suture perforation that was successfully treated with antibiotics. CONCLUSION: Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD.     

Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial

BACKGROUND & AIMS: The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. METHODS: Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. RESULTS: By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. CONCLUSIONS: Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.     

Endoscopic therapies of gastroesophageal reflux disease

The high prevalence of gastroesophageal reflux disease (GERD) in Western societies has accelerated the need for new modalities of treatment. Currently, medical and surgical therapies are widely accepted among patients and physicians. New potent antisecretory drugs and the development of minimally invasive surgery for the management of GERD are at present the pivotal and largely accepted approaches to treatment. The minimally invasive treatment revolution, however, has stimulated several new endoscopic techniques for GERD. Up to now, the data is limited and further studies are necessary to compare the advantages and disadvantages of the various endoscopic techniques to medical and laparoscopic management of GERD. New journal articles and abstracts are continuously being published. The Food and Drug Administration has approved 3 modalities, thus gastroenterologists and surgeons are beginning to apply these techniques. Further trials and device refinements will assist clinicians. This article will present an overview of the various techniques that are currently on study. This review will report the efficacy and durability of various endoscopic therapies for gastroesophageal reflux disease (GERD). The potential for widespread use of these techniques will also be discussed. Articles and abstracts published in English on this topic were retrieved from Pubmed. Due to limited number of studies and remarkable differences between various trials, strict criteria were not used for the pooled data presented, however, an effort was made to avoid bias by including only studies that used off-PPI scoring as baseline and intent to treat.     

A suggested method for laparoscopic herniorrhaphy resident training

Summary The learning curve for laparoscopic herniorrhaphy (LH) is relatively long. Resident training is ideal for the acquisition of operative skills and yet intensive feedback is necessary for more complex procedures. A method whereby faculty provide objective and specific feedback for the technical details of operative LH is described. First a pretest focusing on important aspects of LH and relevant anatomy is given to the resident the day prior to the procedure. Immediately following the operation, the faculty and resident complete an evaluation form together to stimulate discussion and provide constructive feedback. This method of teaching is especially applicable at the resident training level but can be utilized by postgraduate surgeons willing to undergo the criticisms associated with objective operative feedback. Instant operative feedback is beneficial for all including the faculty member who by necessity is forced to communicate in specific terms the operative steps leading to the safe and effective conduct of LH.     

Laparoscopic Nissen fundoplication is an effective treatment for gastroesophageal reflux disease.

OBJECTIVE: The open Nissen fundoplication is effective therapy for gastroesophageal reflux disease. In this study, the outcomes in 198 patients treated with the laparoscopic Nissen fundoplication was evaluated for up to 32 months after surgery to ascertain whether similar positive results could be obtained. SUMMARY BACKGROUND DATA: To ensure surgical success, patients were required to have mechanically defective sphincters on manometry and increased esophageal acid exposure on 24-hour pH monitoring. The patients either had severe complications of gastroesophageal reflux disease or had failed medical therapy. These requirements have been found to be necessary to ensure a successful surgical outcome. METHODS: The disease was complicated by ulceration (46), stricture (25) and Barrett's esophagus (33). Patients underwent standard Nissen fundoplications identical in every detail to open procedures except that the procedures were carried out by the laparoscopic route. RESULTS: Perioperative complications included gastric or esophageal perforation (3), pneumothorax (2), bleeding (2), breakdown of crural repair (2) and periesophageal abscess (1). The only mortality occurred from a duodenal perforation. Six patients required conversion to the open procedure. The median hospital stay was 3 days. One hundred patients were observed for follow-up for 6 to 32 months (median 12 months), with outcomes similar to the open Nissen fundoplication. Further surgery was required for two patients who had recurrent gastroesophageal reflux and one who developed an esophageal stricture. Ninety-seven percent are satisfied with their decision to have the operation. CONCLUSIONS: The laparoscopic Nissen fundoplication can be carried out safely and effectively with similar positive results to the open procedure and with all of the advantages of the minimally invasive approach.     

Surgical repair of recurrent hiatal hernia

The surgical management results of recurrent hiatal hernia repair are unknown in the laparoscopic era. The experience of the senior authors (CJF) and (SKM) is reported herein. From 1993 to 2004, 52 patients underwent re-operative hiatal hernia surgery at our center. Preoperative symptoms were heartburn, chest pain, dysphagia, regurgitation and pulmonary manifestations of gastroesophageal reflux disease. Patients had preoperative evaluation by upper endoscopy, pH-monitoring, esophagogram and manometry to assess the mechanism of failure. Pre- and postoperative symptoms were assessed utilizing a standardized questionnaire. Patients underwent laparoscopic repair (n=18), open laparotomy (n=6) and transthoracic surgery (n=28). Ninety-five percent follow-up was achieved with a mean follow-up of 34 months. Thirty-seven percent of patients encountered para-operative complications one of them died due to respiratory insufficiency. Five patients experienced a re-recurrent hernia. The symptom resolution was 65% for dysphagia, 68% for heartburn, 95% for chest pain and 79% for regurgitation. The overall patient satisfaction was 6.94 on a scale of 1–10. There was no significant difference in patient outcome when comparing the operative approaches or disease process. Surgical repair of recurrent hiatal hernias is safe and effective. Laparoscopic surgery is an appropriate alternative approach for recurrent hiatal hernia repair in selected patients.     

Open laparoscopy for laparoscopic cholecystectomy.

This report deals with the first 350 laparoscopic cholecystectomies performed at Creighton University, beginning in October 1989, by one of the authors (R.J.F., Jr.). An open technique was used for initial access to the abdominal cavity in 343 patients (98%). Patients included 274 females and 76 males, with an average age of 45.5 years. Weight ranged from 72 to 316 pounds (32-142.2 kg). The laparoscopic procedure was successfully completed in 338 (96.6%). Operative cholangiography was performed in 113 (32.3%), and 52 (14.7%) had acute cholecystitis as determined by the final pathological report. Median operating time was 80 min. There was no operative mortality. Bile duct injury was not seen. Postoperative complications occurred in 21 patients (6%), only two of which were directly related to the open technique (cellulitis of the umbilical wound requiring antibiotics). A third patient (0.3% of 343 successful laparoscopies) required reoperation on postoperative day 4 for a small bowel perforation; the exact cause could not be determined, but conceivably it was related to the umbilical minilaparotomy. We conclude that the open technique is safe and effective method for initial peritoneal access prior to laparoscopic cholecystectomy.     

Manometric and radiographic verification of esophageal body decompensation for patients with achalasia.

BACKGROUND: Although morphologic, radiographic, and manometric features of achalasia have been well defined, it has not been established by careful retrospective analysis whether achalasia is a progressive disorder resulting in complete decompensation. STUDY DESIGN: To verify the hypothesis that achalasia is a progressive disease, we retrospectively investigated manometric, radiographic, and symptomatic data in patients with achalasia. Sixty-three patients (36 women and 27 men) with a median age of 44 years (range 11 to 79 years) were evaluated. The duration of symptoms ranged from 1 to 442 months, with a median of 48 months. Patients were divided into four groups according to the duration of symptoms: 36 patients with less than 5 years, 11 with 5 to 10 years, 9 with 10 to 15 years, and 7 with 15 years or more. RESULTS: Contraction pressures of the esophageal body decreased significantly at every level when the duration of symptoms increased (p < 0.04). The percentage of simultaneous waves in the esophageal body rose as the duration of symptoms increased. All waves were synchronous in every patient who had had symptoms for more than 15 years. The maximal width of the esophageal body measured on esophagram became greater with an increase in the duration of symptoms, but this measurement did not reach statistical significance (p = 0.063). The tortuosity of the esophagus, measured by the maximal angle of the esophageal axis, was significantly greater in patients with a longer duration of symptoms (p < 0.02). The type of symptoms was not associated with the duration of symptoms. CONCLUSIONS: Achalasia is a progressive disease, as verified by manometric and radiographic findings. The classification of esophageal motor function expressed by amplitude of contraction pressure and angle of tortuosity is objective and useful. Classification of achalasia by duration of symptoms may be important in treatment selection and effectiveness.