A surgical instrument (200) includes an end effector (202) having a Clevis (224) and first and second jaws (226, 228) mutually rotatable between open and closed positions. The jaws are proximally directed and laterally displaced relative to an axis of a control shaft (206) of the instrument. The jaws hold first and second parts of a fastener, respectively. The first part includes a base having upstanding tissue piercing posts (256), and the second part includes another base defining apertures for receiving the posts, as well as a portion movable relative to the second base. When the upstanding posts are inserted into the apertures, the movable portion can be moved into a second configuration to lock the parts of the fastener together. The instrument is adapted to move the second part into the second configuration. A method for using the apparatus and fastener are also provided.

Surgical fastener aligning instrument particularly for transoral treatment of gastroesophageal reflux disease

Methods and devices are provided for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.

Methods and devices for tissue reconfiguration

GERD was defined according to the Montreal Consensus as “a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications.” Symptoms were considered “troublesome” if they adversely affected an individual’s well-being [5].

From a surgical perspective, GERD is the failure of the antireflux barrier, allowing abnormal reflux of gastric contents into the esophagus [6]. It is a mechanical disorder, which is caused by a defective lower esophageal sphincter (LES), a gastric emptying disorder, or failed esophageal peristalsis. These abnormalities result in a spectrum of disease, ranging from symptoms only, such as “heartburn,” to esophageal tissue damage with or without subsequent complications including malignancy or airway disease. While the exact nature of the antireflux barrier is incompletely understood, the current view is that the LES, the diaphragmatic crura, and the phrenoesophageal ligament are key components [7, 8].

Guidelines for surgical treatment of gastroesophageal reflux disease

Multivariate analysis of factors predicting outcome after laparoscopic Nissen fundoplication.

Several studies have demonstrated laparoscopic antireflux surgery (LAS) for the treatment of gastroesophageal reflux disease (GERD) to be efficient at short- and midterm follow-up evaluations. The aim of this study was to evaluate the results for LAS 10 years after surgery. The 100 consecutive patients who underwent LAS by a single surgeon in 1993 were entered into a prospective database. Nissen fundoplication was performed for 68 patients, and partial posterior fundoplication (modified Toupet procedure) was performed for 32 patients. Evaluations of the outcome were made 5 and 10 years after surgery. A structured symptom questionnaire and upper gastrointestinal barium series were used at 5 years. The same questionnaire and an added quality-of-life questionnaire (the Gastrointestinal Quality of Life Index [GIQLI]) were used at 10 years. Seven patients died of unrelated causes during the 10-year period. Four patients underwent revision surgery: one patient for persistent dysphagia and three patients for recurrent reflux symptoms. Three patients were lost to any follow-up study. At 5 years, 93% of the patients were free of significant reflux symptoms. At 10 years, 89.5% of the patients still were free of significant reflux (93.3% after Nissen, 81.8% after Toupet). Major side effects (flatulence and abdominal distension) were related to “wind” problems. The GIQLI scores at 10 years were significantly better than the preoperative scores of the patients under medical therapy with proton pump inhibitors. Elimination of GERD symptoms improved quality of life and eliminated the need for daily acid suppression in most patients. These results, apparent 5 years after the operation, still were valid at 10 years.

Clinical results of laparoscopic fundoplication at ten years after surgery.

OBJECTIVE: To determine whether division of the short gastric vessels (SGVs) and full mobilization of the gastric fundus is necessary to reduce the incidence of postoperative dysphagia and other adverse sequelae of laparoscopic Nissen fundoplication. SUMMARY BACKGROUND DATA: Based on historical and uncontrolled studies, division of the SGVs has been advocated during laparoscopic Nissen fundoplication to improve postoperative clinical outcomes. However, this modification has not been evaluated in a large prospective randomized trial. METHODS: One hundred two patients with proven gastroesophageal reflux disease presenting for laparoscopic Nissen fundoplication were prospectively randomized to undergo fundoplication with (52 patients) or without (50 patients) division of the SGVs. Patients with esophageal motility disorders, patients requiring a concurrent abdominal procedure, and patients who had undergone previous antireflux surgery were excluded. Patients were blinded to the postoperative status of their SGVs. Clinical assessment was performed by a blinded independent investigator who used multiple standardized clinical grading systems to assess dysphagia, heartburn, and patient satisfaction 1, 3, and 6 months after surgery. Objective measurement of lower esophageal sphincter pressure, esophageal emptying time, and distal esophageal acid exposure and radiologic assessment of postoperative anatomy were also performed. RESULTS: Operating time was increased by 40 minutes (median 65 vs. 105) by vessel division. Perioperative outcomes and complications, postoperative dysphagia, relief of heartburn, and overall satisfaction were not improved by dividing the SGVs. Lower esophageal sphincter pressure, acid exposure, and esophageal emptying times were similar for the two groups. CONCLUSION: Division of the SGVs during laparoscopic Nissen fundoplication did not improve any clinical or objective postoperative outcome.

Prospective Double-Blind Randomized Trial of Laparoscopic Nissen Fundoplication With Division and Without Division of Short Gastric Vessels

Background:

In the operative management of gastro-oesophageal reflux, a balance must be achieved between adequate control of reflux and excessive dysphagia. The ideal technique is not known. A randomized study was performed to determine whether laparoscopic anterior fundoplication is associated with a lower incidence of postoperative dysphagia than laparoscopic Nissen fundoplication, while achieving equivalent control of reflux.



Methods:

Patients presenting for laparoscopic antireflux surgery were randomized to undergo either a Nissen fundoplication (n = 53) or an anterior 180° hemifundoplication (n = 54). Patients were blinded to which procedure had been performed, and follow-up was obtained by a blinded independent investigator. Standardized clinical grading systems were used to assess dysphagia, heartburn and patient satisfaction 1, 3 and 6 months after operation. Objective measurement of lower oesophageal sphincter pressure, oesophageal emptying time, distal oesophageal acid exposure and endoscopic healing of oesophagitis was also performed.



Results:

Operating time was similar for the two procedures (58 min for the Nissen procedure versus 60 min for anterior fundoplication). Resting and residual lower oesophageal sphincter pressures were lower following anterior fundoplication (29 versus 18 mmHg, and 13 versus 6 mmHg), and oesophageal emptying times were faster (92 versus 116 s). Acid exposure times and ability to heal oesophagitis were similar. At 3 months' follow-up clinical outcomes were similar for the two procedures. At 6 months, however, patients who had undergone anterior fundoplication experienced significantly less dysphagia for solid food and were more likely to be satisfied with the clinical outcome.



Conclusion:

Laparoscopic anterior fundoplication achieved equivalent control of reflux, more physiological postoperative manometry parameters, and an improved clinical outcome at 6 months. Continued follow-up remains necessary to confirm the long-term efficacy of the partial fundoplication procedure. © 1999 British Journal of Surgery Society Ltd

Prospective randomized double-blind trial between laparoscopic Nissen fundoplication and anterior partial fundoplication.

Background: Laparoscopic manipulation of malignancies is associated with an increased incidence of metastasis to port sites in experimental models. This study investigated the effect of different insufflation gases on the implantation of a tumor cell suspension following laparoscopic surgery in an established small animal model.

Tumor implantation following laparoscopy using different insufflation gases.

Wound metastasis after laparoscopy with different insufflation gases.

OBJECTIVE To determine the contribution of mechanical factors to the function of different types of fundoplication. DESIGN AND SETTING An experimental bench-top study using abattoir-sourced pig esophagus and stomach placed on a tray. Preliminary esophageal myotomy ensured free reflux of 'intragastric fluid'. INTERVENTIONS Anterior, posterior, and total fundoplications were performed on each of ten sets of viscera. MAIN OUTCOME MEASURES Lower esophageal sphincter pressure was measured using a conventional esophageal manometry catheter. Intragastric pressure was measured with a single channel intragastric manometry catheter, whilst the stomach was inflated with coloured water. The maximum intragastric pressure or the pressure measured when the fundoplication yielded to gastric distension was recorded. RESULTS All three types of fundoplication restored adequate competence to the gastroesophageal junction, although high-volume gastric infusions resulted in fundoplication yield in 4/10 anterior and 4/10 posterior fundoplications. Gastric distension resulted in fundal dilatation and consequent compression of the adjacent esophagus. Fundoplication generated a median rise of 11-13.5 mmHg in lower esophageal sphincter pressure, comparable to pressures reported in the postoperative clinical setting. Significantly greater intragastric volumes and pressures were tolerated following total fundoplication. CONCLUSIONS This study suggests that mechanical factors could be major contributors to the ability of a fundoplication to restore gastroesophageal competence. Anterior, posterior and total fundoplications are all effective procedures.

Gregory K. Pike

Papers

Prospective Double-Blind Randomized Trial of Laparoscopic Nissen Fundoplication With Division and Without Division of Short Gastric Vessels

Prospective randomized double-blind trial between laparoscopic Nissen fundoplication and anterior partial fundoplication.

Tumor implantation following laparoscopy using different insufflation gases.

Wound metastasis after laparoscopy with different insufflation gases.

Comparison of anterior, posterior and total fundoplication using a viscera model.