J THoRAc CARDIOVASC SVRG 85:81-87, 1983
Total fundoplication gastroplasty Long-term follow-up in 500 patients Total fundoplication gastroplasty was designed to combine the low anatomic recurrence rate of gastroplasty with the effectiveness of reflux control obtained by total wrap. The problems requiring evaluation are anatomic recurrence, continued reflux, dysphagia, inability to belch or vomit, and gas bloat, all of which have been described in procedures employing a total wrap. Five hundred consecutive patients were analyzed 6 to 60 months following operation. There were no deaths and a 3.6% incidence of short-term operative morbidity. Follow-up was available clinically in 98.4% (495 patients), radiologically in 89.6% (448), and manometrically in 69.5% (347). Two patients have anatomic recurrence (0.4%) and none has reflux. Excellent results occurred in 93.4% (467), improvement in 5% (25). and poor results in 1.6% (eight). Repeat operation was necessary in 0.4% (two) for recurrence and in 0.8% (four) for severe dysphagia. The other problems were minor dysphagia in 2.2% (11), gastritis in 1.2% (six), late cholelithiasis in 0.4% (two), and continued pain with poor results in 0.4% (two). The length of the gastroplasty tube and the subdiaphragmatic position of the high-pressure zone (HPZ) did not affect the result of the operation. A long tube and unwrapped supradiphragmatic HPZ was present in 18.8% (94); none had reflux or major dysphagia. Total length of the gastroplasty wrap was 3 to 4 em in the first 200 and the incidence of major dysphagia was 5% (10). Reducing the length offundoplication to 1.5 to 2 em reduced the incidence of dysphagia to 1.7% (five). Other problems of gastritis and difficulty with belching and vomiting occurred in a random fashion. This procedure is effective in reflux control, prevents anatomic recurrence and, if the completed fundoplication is maintained at 1.5 to 2 em, yields a low incidence of significant dysphagia.
R. D. Henderson, M.B., and G. Marryatt, R.N. (by invitation), Toronto, Ontario, Canada
G astroplasty was first introduced by Collis in 1961 as an operation to lengthen the esophagus in patients 1
with esophageal shortening. There are several modifications of this operation presently in use. The major variations include a gastroplasty with a Belsey wrap described by Pearson, Langer, and Henderson- in 1971, a stapled uncut gastroplasty with total wrap described by Bingham" in 1977, and a gastroplasty with total wrap described by Henderson" in 1977. The operation described by Collis and Pearson involve a gastric approximation without fundoplication (Collis) or with a 270 degree fundoplication. These are best referred to as partial fundoplication gastroplasties. The operations described by Bingham and Henderson
From the Women's College Hospital, Toronto, Ontario, Canada. Readat the Sixty-second Annual Meeting of The American Association for Thoracic Surgery, Phoenix, Ariz., May 3-5, 1982. Address for reprints: R. D. Henderson, M.B., Women's College Hospital, 76 Grenville St., Toronto, Ontario, Canada M5S IB2. 0022-5223/83/010081+07$00.70/0
© 1983 The
C. V. Mosby Co.
involve a 360 degree fundoplication and are described as total fundoplication gastroplasties. In the present study, long-term follow-up is described in a group of 500 patients, all treated with a cut gastroplasty tube and 360 degree fundoplication. This operative approach is referred to as a total fundoplication gastroplasty.
Patients and methods Five hundred consecutive patients have been treated surgically for intractable gastroesophageal reflux, unresponsive to vigorous conservative management. All patients were studied preoperatively by history, radiology, manometry, endoscopy, pH reflux, and acid perfusion tests. Manometry was conducted with three polyethylene tubes (PE 190) with side openings 5 and 2.5 em apart. Continuous infusion was maintained by means of a syringe pump at 6.8 cc per tube per minute, and pressure changes were detected with Statham P23De strain gauges and recorded on a 1508 Honeywell Visicorder 81
The Journal of
82 Henderson and Marryatt
Thoracic and Cardiovascular Surgery
-50 Maloney
........_ _ Aorta
Vagi with tape
Fig. 1. The esophagogastric junctionis fullymobilized, a tape placed to protect the vagi, and the esophagogastric fat pad removed. A No. 60 Fr. bougie is passed and clamps are placed for cutting the gastroplasty tube. Posterior crural sutures are placed for closure following reduction of the gastroplasty.
recorder. The pH studies were recorded simultaneously with an esophageal probe, and acid perfusion tests were conducted midway through the study. Esophagogastroduodenoscopy was performed on all patients unless an esophageal stricture restricted access to the stomach. Follow-up ranges from 1.25 to 6 years. Clinical follow-up is available in 98%, radiologic studies in 91%, and manometric and pH studies in 70.8%. All patients were treated by total fundoplication gastroplasty. Those with previous esophageal or gastric operations had a thoracoabdominal approach and those treated for the first time had a transthoracic approach. 5. 6 With either approach, the esophagus is mobilized to the aortic arch on its medial and pericardial surfaces and to the inferior pulmonary vein on its aortic surface. The esophagogastric fat pad is removed. An umbilical tape is passed around the intact vagi to hold them clear of the gastroplasty tube incision. Posterior crural sutures of 0 silk are placed, to be tied at the completion of the procedure (Figs. 1 and 2). A No. 60 Fr. bougie is passed by mouth and used as
a guide to the cutting of the gastroplasty tube. Rightangled clamps are placed snugly along the gastroplasty tube. These clamps are used for hemostasis when the tube incision is made. A 3 mm cuff of stomach is left for suture closure, and the tube is cut from the level of the phrenoesophagealligament distally for a distance of 5 ern. The tube and gastric fundus are closed in two layers of continuous locking 3-0 catgut and continuous 3-0 silk sutures. The method of fundoplication varies with the transthoracic and the thoracoabdominal approaches. With the transthoracic approach, the suture line on the gastric fundus is reapproximated to the gastroplasty tube and the distal 1.5 ern of esophagus by means of 4 mattress sutures of 2-0 silk. These sutures cross the suture line and give added strength to the incision. The most proximal suture incorporates the distal 1.5 em of the highpressure zone (HPZ). Stomach fundus is now wrapped medially and laterally around the gastroplasty tube and distal HPZ. The stomach is loosely approximated with a single 2-0 silk mattress suture. This gives a completion wrap of 1 em or less. Two sutures are added for further support to the
Volume 85 Number 1 January, 1983
Total jundoplication gastroplasty
Left Gastric Artery
Fig. 2. Through a thoracoabdominal incision, the esophagogastric junctionis fullymobilized and the proximal fouror five short gastric vessels divided. The esophagogastric fat pad is removed. Posterior crural sutures are placed to be tied following completion of the gastroplasty. A No. 60 Fr. bougie is passed and clamps are placed before the gastroplasty tube is cut.
completion wrap, but these are carefully placed to avoid increasing the length of the fundoplication (Fig. 3). In patients with a marked degree of shortening, the gastroplasty may have to be cut longer and the HPZ may be left in the chest. Since only the distal 1.5 em of esophagus will be reduced below the diaphragm, this procedure already requires much less esophageal reduction than is used in the standard Belsey, 7 Nissen, 8 or Hill" repairs and does accommodate mild degrees of shortening. With the thoracoabdominal approach, the fundus of stomach is wrapped in a clockwise fashion around the gastroplasty tube. The fundus passes down the splenic aspect of the tube posteriorly and is brought up on the hepatic side. The gastroplasty tube is approximated to the fundus of the stomach and distal 1.5 em of the esophagus with interrupted mattress sutures of 2-0 silk. Care is taken to incorporate the gastroplasty suture line blJ( not the suture line on the gastric fundus. The completion wrap is again positioned with one stitch, and two stitches are added for support, but carefully tailored to avoid increasing the length of the completion wrap (Fig. 4). In patients with scleroderma, a previous surgical myotomy, radical previous gastrectomy, or severe esophageal motor damage, the length of wrap is further reduced. The total fundoplication gastroplasty is now placed
83
Fig. 3. Fundus of stomach is sewn to the gastroplasty tube and distal 1.5 em of esophagus. The completion fundoplication is accomplished with three 2-0 silk mattress suturesover a distance of 1 cm. Following completion, the gastroplasty is reduced below the diaphragm and the posteriorcrural sutures are tied. below the diaphragm and crural sutures are loosely approximated. Results Preoperative evaluation. The preoperative symptoms are outlined in Table I. Dysphagia and reflux to the throat are the most specific symptoms, and 92% of the patients had at least one of these symptoms. Radiologically, 60.7% had a hiatal hernia, 16.1% had reflux, and 23.2 % had no abnormalities. Endoscopically, 14.4% had ulcerative esophagitis and 7 .0% had a peptic stricture. During the time of this study, an esophageal or gastric malignant tumor was recognized endoscopically in five patients, but they are not included in this report. A manometric diagnosis of hiatal hernia was made in 68.9% of patients by means of Code and associates'!" method of analysis. The average tone of the HPZ was 12.7 em H 20 and the percentage of disordered motor activity (DMA) in the distal esophagus was 45.5%. Acid perfusion studies were conducted in 464 patients, and definite pain reproduction was observed in 400 of them (86.2%). In this patient group, 182 had previous esophageal or gastric procedures, eight had esophageal scleroderma, and 35 had a peptic stricture. Postoperative follow-up. Patient follow-up is from 1.25 to 6.0 years (average 3.2 years). Ninety-eight percent have had clinical evaluation, 91.0% radiologic studies and manometry, and 70.8% pH studies.
The Journal of Thoracic and Cardiovascular
84 Henderson and Marryatt
5 cm Gastroplasty
Surgery
Table I. Symptoms in 500 patients treated by total fundoplication gastroplasty Pat_ients_ _ Symptoms
,,!'~
"'-Spleen
Fig. 4. The fundus of stomach is wrapped in a clockwise fashion around the gastroplasty tube and distal 1.5 ern of esophagus. The completion wrap uses 3 mattress sutures over a distance of I ern. Following completion, the posterior crural sutures are tied.
There were no deaths, but major morbidity was present in nine patients (1.8%). An esophageal fistula developed in five patients (1.0%), four of these fistulas following operations for recurrent disease. Bowel obstruction developed in three patients and a wound evisceration in one. Minor morbidity included less severe wound infections in six patients and varied problems such as major atelectasis and pneumonia in 10 other patients. In clinical follow-up the most major residual symptom was dysphagia. This was more severe in the early part of the study (the first 200 patients) and became less severe in the latter 300 patients after the wrap completion was reduced to approximately I em in length. In the first group, 10 of the 200 had moderate or severe dysphagia, defined as significant food sticking occurring more frequently than once per week. Five of these have required reoperation. In the second group of 300 patients, only five have had significant dysphagia and one patient has required reoperation for this problem. The six patients requiring further revision procedures for dysphagia had had complicated problems prior to the initial total fundoplication gastroplasty. Two had had three previous operations, one two operations, two had had one operation, and one had had associated bile gastritis. The two with three previous operations had had a gastric procedure, which complicates reflux control operations. Four of these patients are now in satisfactory condition and two are in improved condition but still have significant residual problems. None of these patients have clinical reflux, with the exception of those noted as having an anatomic recurrence.
Heartburn Reflux Aspiration Respiratory symptoms Vomiting Cricopharyngeal dysphagia Gastroesophageal dysphagia Stricture Total dysphagia
I
No.
%
500
43 168 204 358 35
100.0 85.6 40.8 8.6 33.3 40.8 71.6 7.0
388
77.6
428 204
Fifteen percent had difficulty belching. Inability to vomit could not be adequately assessed, as most patients had no urge to vomit. The percentage unable to vomit is almost certainly much higher than the percentage unable to belch. Significant bloating, unresponsive to a short course of methachlopramide, was uncommon (15 patients, 3%). Radiology. Radiologic follow-up is available in 91% of patients. Four have an anatomic recurrence (0.8%) and one has a trace of asymptomatic reflux on water syphon testing. One of the patients with an anatomic recurrence is asymptomatic. Manometry. Manometrically, the HPZ tone rose from a preoperative level of 12.7 H20 to a postoperative level of 17.57 em H20 (an increase of 38 .3%). The tone increase was more marked in those with a lowdose HPZ preoperatively, and on average there was a tone decrease in those with a high-tone HPZ preoperatively. DMA in the distal esophagus fell from a preoperative level of 45.5% to a postoperative level of 28.5% (a decrease of 59.6%). General assessment. The overall patient assessment is that 89.8% have excellent results, 8.2% have minor residual symptoms, and 2.0% have required revision operations either for anatomic recurrence or for dysphagia. Discussion Several aspects of the total fundoplication gastroplasty must be discussed to evaluate its merit as an antireflux procedure. These include its effectiveness in reflux control, the risk of anatomic recurrence, the added morbidity of the procedure, the risk of overcompetence and dysphagia, and the symptomatic quality of the result achieved. Each of these factors will be examined separately.
Volume 85
Number 1
January, 1983
Operations which incorporate a total fundoplication (360 degrees) are much more effective in reflux control than the partial fundoplication procedures. This superiority has been clearly demonstrated in comparisons of the Nissen'! procedure with the Belsey and the Hill repairs. Total reflux control is not by itself the criterion which should be used to assess the quality of result achieved, as with a total fundoplication dysphagia, inability to belch or vomit, and gas bloat may be more common and the overall quality of symptomatic improvement may not be as good. With the total fundoplication gastroplasty, reflux control is excellent. Only one patient had a trace of asymptomatic reflux on water syphon testing. Because of the effectiveness of reflux control, the tone increase in the HPZ was greater than with partial fundoplication procedures. Tone increase was greater in those with a low-tone HPZ prior to operation, probably as a result of total reflux control and tissue healing. That the percentage of DMA in the lower esophagus decreased substantially again indicates effective reflux control. Although we can report only 6 years of follow-up with the total fundoplication gastroplasty, there is over 20 years of follow-up available with gastroplasty tubes, and the anatomic recurrence rate remains at 1.0% to 1.5%.12. 13 This low recurrence rate is probably due to the high quality of tissue available for repair, the lack of tension on the esophagus, and possibly also the use of the left gastric artery as a natural tether to the lower end of the gastroplasty tube. The Nissen," Hill;" Belsey, 16 and Allison!" repairs are all associated with a much higher recurrence rate. Since the gastroplasty procedure adds 20 to 30 minutes to the operating time and includes incision and suturing of the gastric fundus, the potential for increased morbidity and mortality has to be considered. Experience with 277 standard Belsey and 61 standard Nissen operations shows no deaths and a degree of morbidity which, with one exception, is very similar. The recognizable added morbidity with gastroplasty is the presence of five esophageal fistulas (l %), whereas with standard repairs there were no fistulas. Four of the five fistulas occurred in patients with multiple previous operations who would not have been suitable candidates for standard repair and would have required either a gastroplasty or short-segment colon interposition. The added morbidity of total fundoplication gastroplasty in the patients with uncomplicated problems is small. Overcompetence and dysphagia were significant problems in the first 200 patients studied, but reduction of the completion wrap length has significantly reduced
Total Jundoplication gastroplasty
85
their incidence. Use of a very short completion wrap allows total fundoplication to be incorporated in the management of scleroderma, severe secondary DMA, and esophageal myotomy. The length of the completion fundoplication is considered to be critical to the avoidance of dysphagia and affects the overall quality of the result achieved. Finally, the quality of the result achieved is very similar to that achieved with other well-established operations. Of the 500 patients studied, 89.8% have excellent results, 8.2% minor residual symptoms, and 2.0% have had major problems. The potential gain of adding a gastroplasty is the marked reduction in the risk of anatomic recurrence and the ability to handle complex problems of multiple recurrence by means of a more conservative approach than resection and interposition. REFERENCES I Collis JL: Gastroplasty. Thorax 16: 197, 1961 2 Pearson FG, Langer B, Henderson RD: Gastroplasty and Belsey hiatus hernia repair. An operation for the management of peptic stricture with acquired short esophagus. J THORAC CARDIOVASC SURG 61:50, 1971 3 Bingham JA: Hiatus hernia repair combined with the construction of an antireflux valve in the stomach. Br J Surg 64:460, 1977 4 Henderson RD: Reflux control following gastroplasty. Ann Thorac Surg 24:206, 1977 5 Henderson RD, Marryatt G: Recurrent hiatal hernia. Management by thoracoabdominal total fundoplication gastroplasty. Can J Surg 24: 151, 1981 6 Henderson RD: The gastroplasty tube as a method of reflux control. Can J Surg 21:264, 1978 7 Skinner DB, Belsey RHR, Hendrix TR, Zuidema GD, eds.: Gastroesophageal Reflux and Hiatal Hernia, Boston, 1972, Little, Brown & Company 8 Polk HC Jr, Zeppa R: Fundoplication for complicated hiatal hernia. Rationale and results. Ann Thorac Surg 7:202,1969 9 Hill LD: An effective operation for hiatal hernia. An eight-year appraisal. Ann Surg 166:681, 1967 10 Code CF, Creamer B, Schlegel JF, Olsen AM, Donoghue FE, Anderson AA: An Atlas of Esophageal Motility in Health and Disease. Springfield, Ill., 1958, Charles C Thomas, Publisher II DeMeester TR, Johnson LF, Kent AH: Evaluation of current operations for the prevention of gastroesophageal reflux. Ann Surg 180:511,1974 12 Orringer MB, Sloan H: Collis-Belsey reconstruction of the esophagogastric junction. Indications, physiology, and technical considerations. J THORAC CARDIOVASC SURG 71:295, 1976 13 Pearson FG: Surgical management of acquired short
The Journal of
86 Henderson and Marryatt
14
15
16
17
esophagus with dilatable peptic stricture. World J Surg 1:463, 1977 Bettex M, Stillhart H: Operation for hiatus hernia and cardioesophageal achalasia by fundoplication after Nissen. Surgery 55:451, 1964 Sabiston DC, Spencer FC: Technique of Hill, Gibbon's Surgery of the Chest, ed 3, Philadelphia, 1976, W. B. Saunders Company Belsey R: Surgical treatment of hiatus hernia and reflux esophagitis. Introduction (Editorial). World J Surg 1:421, 1977 Allison PR: Hiatus hernia. A 20 year retrospective survey. Ann Surg 178:273, 1973
Discussion
Thoracic and Cardiovascular Surgery
stalsis is lacking, a lesser degree of gastric wrap is necessary in order to avoid postoperative dysphasia. I would ask Dr. Henderson if he has assessed his patients in this regard. Third, we totally agree with the necessity of doing a short, 1.5 cm, gastric wrap and have advocated this for some time. However, our own experience has forced upon us two observations regarding its use. First, a 1.5 ern wrap does not appear to be of sufficient length to protect against reflux in patients who have an extremely low sphincter pressure preoperatively; in this situation, a longer wrap is necessary. Second, a shorter, wrap is more likely to become undone unless some mechanism of reinforcing the sutures is used. I would like to ask Dr. Henderson if he has made any of these observations with his most recent technical modifications and, if so, what has he done about them.
DR. TOM R. DEMEESTER
DR. MARK B. ORRINGER
Palos Heights, lll.
Ann Arbor, Mich.
I congratulate Dr. Henderson for his continued efforts at finding the best method of reconstructing the cardia. He has moved from the Belsey procedure, to the Belsey gastroplasty, to the Nissen gastroplasty, and he now advocates that the length of the gastric wrap in the latter procedure should not exceed 1.5 cm. We agree with this observation, but we feel it is not necessary to incorporate a gastroplasty into the repair. We still believe, as Abraham Lincoln is quoted to have said, that calling a dog's tail a leg doesn't make it a leg and, similarly, calling the stomach esophagus doesn't make it the esophagus. The consequences of an iatrogenic Barrett's esophagus are not known as yet. I would like Dr. Henderson to enlarge upon three areas. The first has to do with the indications for the procedure. Esophageal surgery is functional surgery; that is, the operation is designed to correct function rather than extirpate an organ. This being the case, then the abnormal function should be identified before an attempt is made to correct it. In this regard, we believe that an antireflux procedure is indicated only if incompetency of the cardia is present and has resulted from a demonstrated mechanical defect of the cardia. In our experience, this is present if the distal esophageal sphincter pressure is less than 5 mm Hg or if the length of the abdominal esophagus is I cm or less. (O'Sullivan GC, DeMeester TR, Joelsson BE, Smith RB, Blough RR, Johnson LF, Skinner DB: Interaction of Lower Esophageal Sphincter Pressure and Length of Sphincter in the Abdomen as Determinants of Gastroesophageal Competence. Am J Surg 143:40-47, 1982.) In patients who do not have these indications, there should be reticence to proceed immediately with an antireflux procedure, until other causes of reflux, such as occult gastric disease, are excluded. Dr. Henderson, did you consider these possibilities in the indication for operation or were the indications based solely on symptoms or the presence of esophagitis? Second, we have learned, when performing an antireflux procedure, to match the resistance of the reconstructed valve to the peristaltic power of the esophageal body. When peri-
For the past 7 years, we have used the GIA surgical stapler for construction of the esophagus-lengthening gastroplasty tube. We found that the elongated, narrowed gastric fundus resulting from construction of the gastroplasty was not wide enough to provide a full two-thirds circumferential Belsey fundoplication. Therefore, we began to pass the fundus posteriorly and around the gastroplasty tube for a 360 degree Nissen-type fundoplication, which we then reduced back down below the diaphragm. Of 135 patients who have undergone this Collis-Nissen operation and have been followed for an average of 2 years, 89% have no reflux symptoms. These results are similar to Dr. Henderson's subjective results. Five percent, however, do have moderately severe symptomatic reflux. Nineteen percent of the patients have reported mild, early satiety, or "bloats," after this operation. Upon careful questioning, nearly one third of our patients have experienced some degree of dysphagia after operation. I think this is probably true of any patient who has a fundoplication. However, more than half of these patients have had such mild transient sticking postoperatively that no treatment has been required. Among the 20 patients, or 15% of the total group who have required dilatation, all had either strictures or esophageal spasm preoperatively. Postoperative esophageal function tests have indicated a sustained increase in lower esophageal sphincter tone from about 4 mm Hg preoperatively to about 11 mm Hg postoperatively, and sphincter length has increased from about 1.7 em to about 4 em postoperatively. A total of 18 patients, or 13%, have had abnormal reflux documented objectively with the intraesophageal pH electrode. I was somewhat surprised to see that Dr. Henderson has found no abnormal reflux postoperatively with pH reflux testing in any of his patients. This is indeed a remarkable indication that he may have at last found the perfect antireflux operation! Finally, although the title of this paper indicates that longterm results will be discussed, a minimum follow-up of at least 5 years is required before any operative approach can be
Volume 85 Number 1
January, 1983
said to have proven its value in controlling reflux and its complications. I wonder if Dr. Henderson can tell us the length of follow-up of these patients in his series. DR. FELIX A. EVANGELIST Charlotte, N. C.
We first began using this approach to the difficult hiatal hernia in 1973. As can be seen, we have used the stapler over an indwelling No. 50 Hurst or Maloney bougie to create a 5 em undivided gastroplasty tube and a complete Nissen-type wrap. We have found no reason to alter this technique since that time. Of the 48 patients treated in the first 2 years of our experience, 42 have been available to use for follow-up 8 or 9 years postoperatively. Two of these refused studies other than clinical examinations, and neither of these was symptomatic. One patient with achalasia has had mild intermittent dysphagia since the time of operation, and another patient had what appeared to be an anatomic recurrence of the hernia by roentgenogram but no reflux. This latter patient had swallowed lye I year postoperatively, and the anatomic recurrence occurred after retrograde dilators had been pulled up through the stomach and hiatus for 8 months. All patients were normal by manometric study and by 24 hour pH studies. All of these patients, treated early in our experience, had "complicated" hiatal hernias, with 65% having peptic strictures. We think that the persistent good results over a 9 year period suggest that the combination of gastroplasty and total fundoplication should become the benchmark by which antireflux procedures are measured. DR. HEN 0 E R SON (Closing) I would like to thank Drs. DeMeester , Orringer, and Evangelist for their comments. The points raised are interesting and well worth examining. Some interesting questions have been asked. The length of the cardia below the diaphragm is of great interest to Dr.
Total Jundoplication gastroplasty
87
DeMeester. I find it an extraordinarily difficult thing to measure. A flexible tube is being used, and as the tube is withdrawn the flexion in the tube straightens. Thus I am not convinced that the length of the HPZ below the diaphragm is being measured accurately. In addition, the pressures recorded in the HPZ below the diaphragm vary depending upon the manometric technique. The decrease in peristalsis and its effect on the sphincter are extremely important. At The Society of Thoracic Surgeons meeting in New Orleans, I reported results of extended myotomy using a Nissen for reflux control and indicated that reducing the completion wrap to less than 0.5 ern prevented reflux and avoided the problems of dysphagia. I have similar experience with the use of a gastroplasty and short completion wrap in scleroderma. I believe that Dr. Orringer is describing an operation which technically is substantially different from the one that I am describing. I personally find it very easy to cut a gastroplasty tube and wrap circumferentially. Seventy percent of our patients have undergone follow-up manometric and pH studies. (These are not overnight pH studies but are done together with water syphon testing.) We also have performed radiologic studies on more than 90% of our patients. We do not see reflux using this technique. With the Belsey fundoplication, one is concerned about reflux and reflux symptomatology. With the Nissen type of 360 degree wrap, one is concerned with dysphagia. Our follow-up is 1.5 to 6 years (3.2 years average). Finally, Dr. Evangelist, I am certainly aware of your work in this area. I think it is a major contribution, but I am concerned about the use of the uncut tube. Bingham, who originally reported having used an uncut tube, ran into problems of breakdown of the uncut tube and fistulas forming from the stomach through and into the gastroplasty tube. This mayor may not be a problem, but I think it has to be sought in patients being treated by your operation.