SCIENTIFIC PAPERS
Surgery for Duodenal Ulcer A Study Relating Indications to the Results of Surgery Donald D. Ohme, MD,’ Cleveland, Ohio Johnny Brawner, MD, Cleveland, Ohio Robert E. Hermann, MD, Cleveland, Ohio
For many years, surgeons have tried to determine how to select the safest or best operation for patients with duodenal ulcer. Most studies have shown that vagotomy-drainage is the safest operative procedure whereas vagotomy-antrectomy is the most effective of the traditional operations for duodenal ulcer [l-9]. Since 90 per cent or more of patients will do well after vagotomy and drainage, they should have this safer operation. The question that concerns surgeons is how to identify the 10 per cent of patients most likely to have a recurrence of the ulcer after vagotomypyloroplasty who should have vagotomy-antrectom.r “ly.
Some surgeons have attempted to select patients for vagotomy-drainage or vagotomy-antrectomy on the basis of acid secretory studies [10,11]. During the past fourteen years, we have found acid secretory studies unreliable in the prediction of response to operation for duodenal ulcer. We have relied more on the clinical problems created by the ulcer in the selection of the type of operation for duodenal ulcer disease. For the elective management of most patients with chronic duodenal ulcers of average severity, we have adopted a conservative attitude and have chosen the safest operation, vagotomy-drainage. For the few patients who have had multiple complications or a history of acute, severe ulcer symptoms, vagotomy-antral resection has been chosen. This report is an attempt to determine whether the indications for surgery in patients with duodenal ulcer, intractability to medical therapy, obstruction secondary to pyloric scarring and stenosis, hemorFrom tha Deprtment of General Surgery, The Cleveland Clinic Fwndation and The Cleveland Clinic Educational Foundation, Cleveland, Ohio. Reprint requests should be addressed to Robert E. Hermann, MD, Demment of General Surgsry, Tha Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44106. * Present address: The Sheboygan Clinic, Sheboygan. Wisconsin 5306 1.
Volume 133, March 1977
rhage, or perforation correlate with the results of conservative surgical management. Clinical Material
Two hundred fifteen patients operated on for primary duodenal ulcer disease by one of us (REH) at the Cleveland Clinic from 1963 through 1974 are the basis for this study. Follow-up for all patients was by questionnaires or letters sent annually or by follow-up examination by one of us. Two patients were lost to follow-up. The remaining patients were followed for two to twelve years (mean follow-up for entire group, 6.3 years). The study group consisted of 156 men and 59 women, a ratio of 2.7:1.0, with an age range of seventeen to eighty-four years (mean, 52 years). Indications for Surgery. The most frequent indication for surgery in this group of patients was intractability of the ulcer to continued medical therapy in 108 patients (50.9 per cent). The next most frequent indication was obstruction secondary to pyloric stenosis in fifty-seven patients (26.5 per cent). Hemorrhage was the primary indication for operation in thirty-seven patients (17.2 per cent) and perforation was the indication in thirteen patients (6.0 per cent). All patients classified in the “hemorrhage” group were actively bleeding or had repeated episodes of bleeding as the principal indication for operation. Not included in this classification were patients who had a history of bleeding but whose principal indication for surgery was now pain or pyloric stenosis. Table I correlates indications for surgery with the ratio of males to females, mean age of the patients, duration of symptoms, and subsequent operative mortality. Death occurred only in those patients with acute; severe ulcer disease (hemorrhage or perforation) operated on in an emergency situa-
267
Ohme, Brawner,
TABLE
and Hermann
I Indications
for Surgery
Ratio Males/ Females Intractability (108 patients) Obstruction (57 patients) Hemorrhage (37 patients) Perforation (13 patients) Total group (215 patients)
Mean Mean Duration Age of of Pa- Symptients toms (vr) (yr)
Operative Mortality
2.611
49
13
0%
2.0/l
54
11
0%
4.2/l
55
10
8% (3/37)
3.3/l
54
1
2.711
52
8.8
tion. None of the patients died.
electively
operation. Additional operative procedures performed in forty-four patients included cholecystectomy (20 patients), hiatal hernia repair (ll), splenectomy (5), appendectomy (3), terminal ileum resection (l), sigmoid resection (l), ovarian cystectomy (l), liver wedge resection (l), and abdominoperineal resection (1). Seventeen patients, not included in this series, had a combined gastric ulcer and duodenal ulcer or scar evidence of a healed duodenal ulcer. Since the gastric ulcer was the primary indication for surgery, these patients were excluded from this study.
7.6% (l/13) 1.8% (4/215)
operated
on
Duration of Symptoms. The duration of symptoms in the entire group of 215 patients ranged from the sudden onset of pain from a perforated ulcer, as the first symptom, to one patient with intractability who had lived with episodic ulcer pain, intermittently controlled by medical therapy, for forty-six years. It is of interest that all patients in the perforation group had symptoms less than five years. In the group of patients with intractability, symptoms ranged from four months to forty-six years (mean duration of symptoms, 13 years). Twenty of the patients had symptoms longer than twenty-one years. Type of Operation. The majority of patients in this study, 206 (96 per cent), had truncal vagotomy and drainage. The operation most frequently performed was truncal vagotomy-pyloroplasty in 190 patients (88.3 per cent); the second most common operation was truncal vagotomy-gastrojejunostomy in sixteen patients (7.4 per cent). Four patients (2 per cent) had truncal vagotomy-antrectomy and five patients (2 per cent) had other procedures including subtotal gastrectomy without vagotomy, plication of a perforated ulcer, or pyloroplasty alone with oversew of a bleeding ulcer. Additional Problems. In addition to the primary ulcer operation, forty-four patients also had a second operation performed during the same operative procedure because of other identified disease. Cholelithiasis was the most common disease or pathologic finding in this group; twenty patients (9.7 per cent) had gallstones. Hiatal hernia was the second most common finding in eleven patients (5 per cent). A duodenal diverticulum was identified in twelve patients. Two patients (1 per cent) had pancreatitis at
266
Results Operative Mortality. Four patients died after operation, prior to discharge from the hospital or in the thirty day postoperative period, an operative mortality of 1.8 per cent. These four patients had been operated on as emergencies, three because of severe hemorrhage and one because of a perforated ulcer. The cause of death in the four patients included pulmonary embolism, liver failure, myocardial infarction, and postoperative sepsis. None of the patients in whom an elective operation was performed died. Eight of the thirty-seven patients whose indication for surgery was hemorrhage were operated on as emergencies for severe uncontrolled bleeding; in addition, the thirteen patients with perforated ulcer were emergencies-a total of twenty-one emergency operations (10 per cent of the total series). The contrast between the operative mortality in patients operated on electively (O/194) and those in whom emergency surgery was required (4/21,19 per cent) is striking. Morbidity and Ulcer Recurrence. All patients were graded annually by follow-up questionnaires or by personal interview, according to the criteria of Hoerr and Ward [3]:
(A) No gastrointestinal symptoms. (B) Minor gastrointestinal symptoms; no evidence of recurrent ulcer. The patient is satisfied with the results of operation. (C) The patient is dissatisfied with gastrointestinal function, but there is no evidence of a recurrent ulcer. (D) Recurrent ulcer, proved or probable; or the patient has other disabling gastrointestinal symptoms. Of the 215 patients, 202 are available for two to twelve year follow-up (4 patients died postoperatively, 2 patients were lost to follow-up, and 7 pa-
The American Journal of Surgery
Duodenal
tients died within 2 years after surgery from other disease). The mean duration of follow-up is 6.3 years. Ratings of A and B were considered excellent or good results; ratings of C or D were considered unsatisfactory results. In the entire group, 172 patients (85 per cent) had excellent or good results, eleven patients (5 per cent) were dissatisfied with gastrointestinal function, and twenty patients (10 per cent) had predominantly symptoms of a recurrent ulcer. (Table II.) Despite recurrent ulcer symptoms in twenty patients, only six patients (3 per cent) in this series required a second operative procedure. (Table III.) Four of these six operations were for proved duodenal ulcer disease (recurrent or continuing) and two were for stenosis of a previous pyloroplasty. There were no deaths after these second operations. Postoperative symptoms of gastrointestinal dysfunction included diarrhea in sixty-three patients (29 per cent) (in only 1 patient was the diarrhea severe enough to cause occasional time lost at work), constipation in six patients (2.8 per cent), mild dumping symptoms in twenty patients (10 per cent), mild symptoms of bile reflux gastritis and vomiting in three patients, weight loss of more than 5 pounds (2.8 kg) in forty-nine patients (22.8 per cent), and weight gain of more than 5 pounds (2.8 kg) in thirty-two patients (15 per cent). Intractability. Of the 108 patients who chose to undergo surgery for duodenal ulcer because of symptoms intractable to long-term medical control, none died postoperatively, two died within two years after surgery (1 from metastatic bronchial carcinoid and 1 committed suicide), and none were lost to follow-up. Eighty-seven of the remaining 106 patients (82 per cent) were considered excellent or good results, seven patients (7 per cent) were dissatisfied with their gastrointestinal function, and twelve patients (11 per cent) had recurrent ulcer symptoms. (Table II.) Only one patient has required another
TABLE
III
Second
Operative
operative procedure for recurrent ulcer symptoms in this group; the other eleven patients are acceptably controlled by further medical management. Obstruction. Of the fifty-seven patients with significant pyloric stenosis or gastric outlet obstruction, none died postoperatively, two died within two years after surgery (1 from a myocardial infarction and 1 from acute hemorrhagic pancreatitis), and two were lost to follow-up. Fifty-one of the remaining fiftythree patients (96 per cent) were considered excellent or good results, none of the patients were dissatisfied with their gastrointestinal function, and two patients (4 per cent) had recurrent ulcer symptoms. No patient has required a second operative procedure. Hemorrhage. Of the thirty-seven patients whose principal indication for operation was bleeding, three died postoperatively, one additional patient died within two years after operation (from gastrointestinal bleeding and hepatic coma), and none were lost to follow-up. Twenty-eight of the remaining thirtythree patients (85 per cent) eligible for two to twelve
TABLE I I
Correlation of Operative Indications with Results of Surgery (202 patients followed 2 to 12 years) Results of Surgery
Indications
7%
Obstruction
(87/106) 96%
(7/106) 0%
1 1% (12/106) 4%
Hemorrhage
(51/53) 85%
(O/53) 0%
(2153) 15%
Perforation
(28/33) 60%
(0133) 30%
Total
group
3% (3/106)
Obstruction Hemorrhage
0% (O/53) 3% (l/33)
(1) Obstruction (2) Obstruction (3) Recurrent ulcer None Continued bleeding from ulcer (1) Recurrent ulcer (2) Recurrent ulcer
group
Volume 133, March 1977
(6/10) 85% (172/202)
(3/10) 5% (10/202)
(5/33) 10% (l/10) 10% (20/202)
Procedures
Intractability
Total
Dissatisfied
Recurrent Ulcer Symptoms
82%
Indications for 2nd Operation
Perforation
ExcellentGood
Intractability
Incidence of 2nd Operation
Indications for Primary Operation
Ulcer
20% (2/10)
Procedure Performed (2nd operation) (1) Revision pyloroplasty (2) Gastrojejunostomy (3) Antral resection Subtotal
gastrectomy
(1) Vagotomy-pyloroplasty (2) Vagotomy-pyloroplasty
3% (61202)
269
Ohrne, Brawner,
TABLE
IV
and Hermann
Correlation
of Type of Operation
with
Results
(202 patients
followed
2 to 12 years)
Results of Surgery Type of Operation Vagotomy-pyloroplasty Vagotomy-gastrojejunostomy Vagotomy-antrectomy Other operations Total
Excellent-Good 86% 88% 50% 75% 85%
(153/178) (14/16) (2/4) (3/4) (172/202)
year follow-up were considered excellent or good results, none of the patients were dissatisfied with gastrointestinal function, and five patients (15 per cent) had recurrent ulcer symptoms. One patient (Table III) had subtotal gastrectomy after previous vagotomy-pyloroplasty had failed to control the bleeding ulcer; the other four patients with recurrent ulcer symptoms have not bled again and are controlled by medical management. Perforation. Of the thirteen patients whose duodenal ulcer perforated, one died postoperatively, two died within two years after surgery (both of myocardial infarctions), and none were lost to follow-up. Six of the remaining ten patients (60 per cent) are considered excellent or good results, three patients (30 per cent) are dissatisfied with their gastrointestinal function, and one patient (10 per cent) has recurrent ulcer symptoms controlled medically. Correlation
of Type of Operation
and Results.
Table IV correlates the results of surgery with the type of operation performed. Since the majority of operations performed were truncal vagotomy-pyloroplasty, no valid comparison of this procedure with the few patients in this series who had other procedures can be made. Nevertheless, this correlation is included for completeness. Comments
The many reports which have been published comparing surgical procedures for the treatment of duodenal ulcer have greatly increased our knowledge about the effectiveness and safety of these operative procedures. From these reports, it appears that truncal vagotomy and a drainage procedure is the safest of the traditional ulcer operations with the lowest overall operative mortality, 0.5 to 1.5 per cent, but with an ulcer recurrence of approximately 10 per cent [l-9,12-14]. Truncal vagotomy-antrectomy has a higher operative mortality, 2.0 to 3.0 per cent, but is probably the most effective ulcer operation with an ulcer recurrence rate of approximately 3 per cent [1,3,5,7,11,13,15,16]. Recent reports evaluating se-
270
Dissatisfied 4% 6% 25% 25% 5%
(7/178) (l/16) (l/4) (l/4) (10/202)
Recurrent Ulcer Symptoms 10% 6% 25% 0% 10%
(18/178) (l/l 6) (l/4) (O/4) (20/202)
lective vagotomy and drainage or antrectomy, or proximal gastric vagotomy (highly selective vagotomy) with or without a drainage procedure give evidence that these operations show promise in being both effective and safe procedures, although their precise role and long-term results are not as yet clear [I 7-211. During the past ten to fifteen years, because of the safety of vagotomy-drainage and the fact stated so well by Wangensteen [22] that “. . . death is more serious than ulcer recurrence,” we have used vagotomy-drainage to treat the majority of our patients with duodenal ulcer disease. However, we have recognized that 10 per cent of these patients are likely to have recurrent ulcer symptoms. The problem is that we do not know how to recognize this 10 per cent of patients in advance, so that in this group a more effective operation, vagotomy-antrectomy, might be used. If we could recognize the increased risk of ulcer recurrence in advance, the slightly increased risk of operative mortality might be justified. Acid secretory studies have not helped us recognize this group of patients. Our experience, along with that of many others, has been that acid secretory studies have not been reliably predictable in correlating with the severity of the disease in the individual patient [1,2,10,14,21]. As in many laboratory tests, high acid values have been obtained in some individuals with minimal indications for surgery, and significantly lower values have been found in other patients with apparently severe ulcer disease. Acid secretory studies are subject to errors in the proper placement of the nasogastric tube; confusion as to whether overnight specimens, basal specimens, betazole (Histalog@)-stimulated, maximum histamine-stimulated, pentagastrin-stimulated, or insulin-stimulated specimens were the best indicators; delay in analysis of the collected specimens (some specimens are placed in the refrigerator and analyzed the following day); and confusion in reporting the results (mEq/liter or mEq/hour). More recently, laboratory assessment of serum gastrin levels has also begun to show a range of values
The American Journal of Surgery
and a lack of correlation with the severity of the disease, as well as confusion as to whether the gastrin levels should be obtained in the fasting or stimulated state. Since the laboratory assessment of patients with duodenal ulcer has not been reliably predictable in selecting those patients who require a larger or more effective operation, we have, in this study, turned back to the patient with the thesis that the way the ulcer disease expresses itself in any individual patient may be the best guide to the selection of the most effective operative procedure for that patient. Our initial premise was that most patients have chronic duodenal ulcer disease of some years duration reasonably well managed medically during these years by diet and antacid therapy. At some point in their experience, the ulcer becomes less manageable and more painful or interferes more with their lives. At this time the patients are willing to undergo surgery for control of what has now become an intractable duodenal ulcer. Other patients, after years of successful medical control, with repeated episodes of reactivation of the ulcer and healing by scar tissue, eventually have enough scarring of the pyloric channel or duodenum that pyloric stenosis develops and surgery is required. A few patients have a more acute or virulent expression of ulcer disease regardless of acid secretory values, and sudden episodes of bleeding or perforation occur. Our thesis was that patients with intractability or stenosis as an indication for surgery might do well after a lesser and safer operative procedure, vagotomy-drainage, whereas patients with bleeding or perforation might show a greater tendency to recurrent ulcer disease. This thesis has been only partially substantiated by this study. We have found that, although excellent or good results were obtained in 96 per cent of patients with obstruction and 82 per cent of patients with intractability, recurrent ulcer symptoms became evident in the follow-up of 4 and 11 per cent, respectively, of patients in these two groups. However, only three of 159 patients (2 per cent) required another operative procedure. These results are contrasted with those obtained in the patients with indications of hemorrhage or perforation who had excellent or good results after operation in 85 and 60 per cent of patients, respectively, and recurrent ulcer symptoms in 15 and 10 per cent of patients, respectively. In these two groups, three of forty-three patients (7 per cent) required another operative procedure. In the two groups of patients with indications of intractability and patients with perforation, dissatisfaction with gastrointestinal function was reported
Vohima 133, March 1977
in 7 and 30 per cent, respectively. This was not found, surprisingly, in any of the patients who had obstruction or hemorrhage as indications for surgery. A comparison of the types of operations performed in this series of patients cannot be adequately assessed since most of the patients had truncal vagotomy-pyloroplasty. The incidence of excellent or good results was high in the patients who had vagotomypyloroplasty (86 per cent), as it was in those patients who had vagotomy-gastrojejunostomy (88 per cent), and the incidence of patient dissatisfaction was low (4 and 6 per cent, respectively). The incidence of recurrent ulcer symptoms was 10 per cent after vagotomy-pyloroplasty and only 6 per cent after vagotomy-gastrojejunostomy. Four of the six patients who required a second operation had previous vagotomy-pyloroplasty, but only two patients had recurrent or continuing ulcer as the indication for surgery. The other indications for a second operation in this series were for obstruction due to stenosis of the pyloroplasty in two patients and for vagotomy-pyloroplasty after simple closure of a perforated ulcer in two patients. This series demonstrates that a conservative approach to the surgical management of duodenal ulcer disease is justified and that truncal vagotomy-pyloroplasty or -gastrojejunostomy is a safe operative procedure. None of the patients electively operated on died. Most patients are satisfied with the results and few are dissatisfied or have recurrent duodenal ulcers. We did not demonstrate conclusively that the symptoms of duodenal ulcer disease in the individual patient can be used alone as a guide to operative management. However, our results suggest that the indications for surgery may be one factor that will enable the surgeon to predict which patients should do well after vagotomy-drainage,or which patients might require a more aggressive surgical approach. At the present time, we are continuing a conservative operative approach for most patients with duodenal ulcer disease, trying to individualize and identify those patients who might require a more aggressive initial operation by virtue of a history of bleeding or perforation, taking into account age, sex, lifestyle, body habitus, acid secretory studies, and duration of symptoms. Summary
The present study correlates the indications for operation in 215 patients with duodenal ulcer disease with the results of operative management. The majority of patients had conservative surgery utilizing truncal vagotomy and pyloroplasty or gastrojejunostomy. None of the 194 patients operated on elec-
271
Ohme, Brawner, and Hermann
tively died and four patients died after emergency operations, for an overall operative mortality in the entire series of 1.8 per cent. The incidence of recurrent ulcer symptoms in all patients was 10 per cent. We could demonstrate only a modest correlation between indications for operation and long-term results of conservative surgical management; the indication for surgery, whether that of chronic (intractability, stenosis) or more acute (hemorrhage, perforation) ulcer disease is only moderately reliable as a predictor of long-term results. In this series of patients, those with obstructing duodenal ulcers (pyloric stenosis) had the best long-term results after conservative surgical management. References 1. Brooks JR, Dariush K, Membreno AA: Truncal vagotomy and pylaroplasty for duodenal ulcer. Arch Surg 110: 822, 1975. 2. Eisenberg MM, Woodward El?, Carson TJ, et al: Vagotomy and drainage procedure for duodenal ulcer; the results of ten years’ experience. Ann Surg 170: 317, 1969. 3. Hoerr SO, Ward JT: late results of three operations for chronic duodenal ulcer; vagotomy-gastrojejunostomy, vagotomyhemigastrectomy, vagotomy-pyloroplastysty; Interim report. Ann Surg 176: 403, 1972. 4. Elective operations performed for duodenal ulcer, with their mortality. Results of a Second Survey in Selected Ohio Hospitals by Survey Committee, Ohio Chapter, American College of Surgeons. Am J Surg 114: 427, 1967. 5. Howard RJ, Murphy WR, Humphrey EW: A prospective randomized shady of the elective surgical treatment for duodenal ulcer; two- to ten-year follow-up study. Surgery 73: 256, 1973. 6. McDonald CD, Abtahi H: Critical appraisal of vagotomy and pyloroplasty; treatment of peptic ulcer. Arch Surg 100: 414,
272
1970. 7. Price WE, Grizzle JE, Postlethwait RW, et al: Results of operation for duodenal ulcer. Surg Gynecol Obsfet 131: 233, 1970. 8. Schlicke CP, Logan A: Lessons learned from the use of vagotomy in the treatment of peptic ulcer. Am J Swg 124: 121, 1972. 9. Schofield PF, Watson-Williams EJ, Sorrel1 VF: Vagotomy and pyloric drainage for chronic duodenal ulcer. Arch Surg 95: 615,1967. 10. Robbs JV, Bank S, Marks IN, et al: Selection of operation for duodenal ulcer based on acid secretory studies; a reappraisal. Br J Surg 60: 601, 1973. 11. Smithwick RH, Farmer DA, Harrower HW: Hemigastrectomy and truncal vagotomy in the treatment of duodenal ulcer. Am JSurg 127: 631, 1974. 12. Dragstedt LR II, Lulu DJ: Truncal vagotomy and pyloroplasty; critical evaluation of one hundred cases. Am J Surg 128: 344, 1974. 13. Hoen SO: Comparative results of operations for duodenal ulcer; a twenty year personal experience. Am J Surg 125: 3, 1973. 14. Kennedy F, MacKay C. Bedi BS, et al: Truncal vagotomy and drainage for chronic duodenal ulcer disease; a controlled trial. Br Med J 2: 71, 1973. 15. Herrington JL Jr, Sawyers JL, Scott HW Jr: A 25-year experience with vagotomy-antrectomy. Arch Surg 106: 469, 1973. 16. Palumbo LT, Sharpe WS, Lulu DJ, et al: Distal antrectomy with vagectomy for duodenal ulcer. Arch Surg 100: 182, 1970. 17. Miller B, Bombeck CT, Schumer W, et al: Vagotomy limited to the parietal cell mass. Arch Surg 103: 153, 1971. 18. Amdrup E, Andersen D, Hostrup H: The Aarhus County vagotomy trial: preliminary results. Chir Gestroenterol 9: 189, 1975. 19. Hedenstedt S: Experiences of selective proximal vagotomy (SPV)--400 cases of uncomplicated and complicated ulcers during 6 years. Ghir Gestroenferol9: 205, 1975. 20. Jordan PH Jr: Parietal cell vagotomy without drainage. Arch Surg 108: 434, 7974. 21. Nyhus LM: Two decades of gastrointestinal research. Am J Surg 131: 3, 1976. 22. Wangensteen SL: Ulcer recuTence versus death in peptic ulcer surgery. Am J Surg 119: 254, 1970.
The American Journal of Surgery
Surgery for Duodenal Ulcer A Study Relating Indications to the Results of Surgery Donald D. Ohme, MD,’ Cleveland, Ohio Johnny Brawner, MD, Cleveland, Ohio Robert E. Hermann, MD, Cleveland, Ohio
For many years, surgeons have tried to determine how to select the safest or best operation for patients with duodenal ulcer. Most studies have shown that vagotomy-drainage is the safest operative procedure whereas vagotomy-antrectomy is the most effective of the traditional operations for duodenal ulcer [l-9]. Since 90 per cent or more of patients will do well after vagotomy and drainage, they should have this safer operation. The question that concerns surgeons is how to identify the 10 per cent of patients most likely to have a recurrence of the ulcer after vagotomypyloroplasty who should have vagotomy-antrectom.r “ly.
Some surgeons have attempted to select patients for vagotomy-drainage or vagotomy-antrectomy on the basis of acid secretory studies [10,11]. During the past fourteen years, we have found acid secretory studies unreliable in the prediction of response to operation for duodenal ulcer. We have relied more on the clinical problems created by the ulcer in the selection of the type of operation for duodenal ulcer disease. For the elective management of most patients with chronic duodenal ulcers of average severity, we have adopted a conservative attitude and have chosen the safest operation, vagotomy-drainage. For the few patients who have had multiple complications or a history of acute, severe ulcer symptoms, vagotomy-antral resection has been chosen. This report is an attempt to determine whether the indications for surgery in patients with duodenal ulcer, intractability to medical therapy, obstruction secondary to pyloric scarring and stenosis, hemorFrom tha Deprtment of General Surgery, The Cleveland Clinic Fwndation and The Cleveland Clinic Educational Foundation, Cleveland, Ohio. Reprint requests should be addressed to Robert E. Hermann, MD, Demment of General Surgsry, Tha Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44106. * Present address: The Sheboygan Clinic, Sheboygan. Wisconsin 5306 1.
Volume 133, March 1977
rhage, or perforation correlate with the results of conservative surgical management. Clinical Material
Two hundred fifteen patients operated on for primary duodenal ulcer disease by one of us (REH) at the Cleveland Clinic from 1963 through 1974 are the basis for this study. Follow-up for all patients was by questionnaires or letters sent annually or by follow-up examination by one of us. Two patients were lost to follow-up. The remaining patients were followed for two to twelve years (mean follow-up for entire group, 6.3 years). The study group consisted of 156 men and 59 women, a ratio of 2.7:1.0, with an age range of seventeen to eighty-four years (mean, 52 years). Indications for Surgery. The most frequent indication for surgery in this group of patients was intractability of the ulcer to continued medical therapy in 108 patients (50.9 per cent). The next most frequent indication was obstruction secondary to pyloric stenosis in fifty-seven patients (26.5 per cent). Hemorrhage was the primary indication for operation in thirty-seven patients (17.2 per cent) and perforation was the indication in thirteen patients (6.0 per cent). All patients classified in the “hemorrhage” group were actively bleeding or had repeated episodes of bleeding as the principal indication for operation. Not included in this classification were patients who had a history of bleeding but whose principal indication for surgery was now pain or pyloric stenosis. Table I correlates indications for surgery with the ratio of males to females, mean age of the patients, duration of symptoms, and subsequent operative mortality. Death occurred only in those patients with acute; severe ulcer disease (hemorrhage or perforation) operated on in an emergency situa-
267
Ohme, Brawner,
TABLE
and Hermann
I Indications
for Surgery
Ratio Males/ Females Intractability (108 patients) Obstruction (57 patients) Hemorrhage (37 patients) Perforation (13 patients) Total group (215 patients)
Mean Mean Duration Age of of Pa- Symptients toms (vr) (yr)
Operative Mortality
2.611
49
13
0%
2.0/l
54
11
0%
4.2/l
55
10
8% (3/37)
3.3/l
54
1
2.711
52
8.8
tion. None of the patients died.
electively
operation. Additional operative procedures performed in forty-four patients included cholecystectomy (20 patients), hiatal hernia repair (ll), splenectomy (5), appendectomy (3), terminal ileum resection (l), sigmoid resection (l), ovarian cystectomy (l), liver wedge resection (l), and abdominoperineal resection (1). Seventeen patients, not included in this series, had a combined gastric ulcer and duodenal ulcer or scar evidence of a healed duodenal ulcer. Since the gastric ulcer was the primary indication for surgery, these patients were excluded from this study.
7.6% (l/13) 1.8% (4/215)
operated
on
Duration of Symptoms. The duration of symptoms in the entire group of 215 patients ranged from the sudden onset of pain from a perforated ulcer, as the first symptom, to one patient with intractability who had lived with episodic ulcer pain, intermittently controlled by medical therapy, for forty-six years. It is of interest that all patients in the perforation group had symptoms less than five years. In the group of patients with intractability, symptoms ranged from four months to forty-six years (mean duration of symptoms, 13 years). Twenty of the patients had symptoms longer than twenty-one years. Type of Operation. The majority of patients in this study, 206 (96 per cent), had truncal vagotomy and drainage. The operation most frequently performed was truncal vagotomy-pyloroplasty in 190 patients (88.3 per cent); the second most common operation was truncal vagotomy-gastrojejunostomy in sixteen patients (7.4 per cent). Four patients (2 per cent) had truncal vagotomy-antrectomy and five patients (2 per cent) had other procedures including subtotal gastrectomy without vagotomy, plication of a perforated ulcer, or pyloroplasty alone with oversew of a bleeding ulcer. Additional Problems. In addition to the primary ulcer operation, forty-four patients also had a second operation performed during the same operative procedure because of other identified disease. Cholelithiasis was the most common disease or pathologic finding in this group; twenty patients (9.7 per cent) had gallstones. Hiatal hernia was the second most common finding in eleven patients (5 per cent). A duodenal diverticulum was identified in twelve patients. Two patients (1 per cent) had pancreatitis at
266
Results Operative Mortality. Four patients died after operation, prior to discharge from the hospital or in the thirty day postoperative period, an operative mortality of 1.8 per cent. These four patients had been operated on as emergencies, three because of severe hemorrhage and one because of a perforated ulcer. The cause of death in the four patients included pulmonary embolism, liver failure, myocardial infarction, and postoperative sepsis. None of the patients in whom an elective operation was performed died. Eight of the thirty-seven patients whose indication for surgery was hemorrhage were operated on as emergencies for severe uncontrolled bleeding; in addition, the thirteen patients with perforated ulcer were emergencies-a total of twenty-one emergency operations (10 per cent of the total series). The contrast between the operative mortality in patients operated on electively (O/194) and those in whom emergency surgery was required (4/21,19 per cent) is striking. Morbidity and Ulcer Recurrence. All patients were graded annually by follow-up questionnaires or by personal interview, according to the criteria of Hoerr and Ward [3]:
(A) No gastrointestinal symptoms. (B) Minor gastrointestinal symptoms; no evidence of recurrent ulcer. The patient is satisfied with the results of operation. (C) The patient is dissatisfied with gastrointestinal function, but there is no evidence of a recurrent ulcer. (D) Recurrent ulcer, proved or probable; or the patient has other disabling gastrointestinal symptoms. Of the 215 patients, 202 are available for two to twelve year follow-up (4 patients died postoperatively, 2 patients were lost to follow-up, and 7 pa-
The American Journal of Surgery
Duodenal
tients died within 2 years after surgery from other disease). The mean duration of follow-up is 6.3 years. Ratings of A and B were considered excellent or good results; ratings of C or D were considered unsatisfactory results. In the entire group, 172 patients (85 per cent) had excellent or good results, eleven patients (5 per cent) were dissatisfied with gastrointestinal function, and twenty patients (10 per cent) had predominantly symptoms of a recurrent ulcer. (Table II.) Despite recurrent ulcer symptoms in twenty patients, only six patients (3 per cent) in this series required a second operative procedure. (Table III.) Four of these six operations were for proved duodenal ulcer disease (recurrent or continuing) and two were for stenosis of a previous pyloroplasty. There were no deaths after these second operations. Postoperative symptoms of gastrointestinal dysfunction included diarrhea in sixty-three patients (29 per cent) (in only 1 patient was the diarrhea severe enough to cause occasional time lost at work), constipation in six patients (2.8 per cent), mild dumping symptoms in twenty patients (10 per cent), mild symptoms of bile reflux gastritis and vomiting in three patients, weight loss of more than 5 pounds (2.8 kg) in forty-nine patients (22.8 per cent), and weight gain of more than 5 pounds (2.8 kg) in thirty-two patients (15 per cent). Intractability. Of the 108 patients who chose to undergo surgery for duodenal ulcer because of symptoms intractable to long-term medical control, none died postoperatively, two died within two years after surgery (1 from metastatic bronchial carcinoid and 1 committed suicide), and none were lost to follow-up. Eighty-seven of the remaining 106 patients (82 per cent) were considered excellent or good results, seven patients (7 per cent) were dissatisfied with their gastrointestinal function, and twelve patients (11 per cent) had recurrent ulcer symptoms. (Table II.) Only one patient has required another
TABLE
III
Second
Operative
operative procedure for recurrent ulcer symptoms in this group; the other eleven patients are acceptably controlled by further medical management. Obstruction. Of the fifty-seven patients with significant pyloric stenosis or gastric outlet obstruction, none died postoperatively, two died within two years after surgery (1 from a myocardial infarction and 1 from acute hemorrhagic pancreatitis), and two were lost to follow-up. Fifty-one of the remaining fiftythree patients (96 per cent) were considered excellent or good results, none of the patients were dissatisfied with their gastrointestinal function, and two patients (4 per cent) had recurrent ulcer symptoms. No patient has required a second operative procedure. Hemorrhage. Of the thirty-seven patients whose principal indication for operation was bleeding, three died postoperatively, one additional patient died within two years after operation (from gastrointestinal bleeding and hepatic coma), and none were lost to follow-up. Twenty-eight of the remaining thirtythree patients (85 per cent) eligible for two to twelve
TABLE I I
Correlation of Operative Indications with Results of Surgery (202 patients followed 2 to 12 years) Results of Surgery
Indications
7%
Obstruction
(87/106) 96%
(7/106) 0%
1 1% (12/106) 4%
Hemorrhage
(51/53) 85%
(O/53) 0%
(2153) 15%
Perforation
(28/33) 60%
(0133) 30%
Total
group
3% (3/106)
Obstruction Hemorrhage
0% (O/53) 3% (l/33)
(1) Obstruction (2) Obstruction (3) Recurrent ulcer None Continued bleeding from ulcer (1) Recurrent ulcer (2) Recurrent ulcer
group
Volume 133, March 1977
(6/10) 85% (172/202)
(3/10) 5% (10/202)
(5/33) 10% (l/10) 10% (20/202)
Procedures
Intractability
Total
Dissatisfied
Recurrent Ulcer Symptoms
82%
Indications for 2nd Operation
Perforation
ExcellentGood
Intractability
Incidence of 2nd Operation
Indications for Primary Operation
Ulcer
20% (2/10)
Procedure Performed (2nd operation) (1) Revision pyloroplasty (2) Gastrojejunostomy (3) Antral resection Subtotal
gastrectomy
(1) Vagotomy-pyloroplasty (2) Vagotomy-pyloroplasty
3% (61202)
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Ohrne, Brawner,
TABLE
IV
and Hermann
Correlation
of Type of Operation
with
Results
(202 patients
followed
2 to 12 years)
Results of Surgery Type of Operation Vagotomy-pyloroplasty Vagotomy-gastrojejunostomy Vagotomy-antrectomy Other operations Total
Excellent-Good 86% 88% 50% 75% 85%
(153/178) (14/16) (2/4) (3/4) (172/202)
year follow-up were considered excellent or good results, none of the patients were dissatisfied with gastrointestinal function, and five patients (15 per cent) had recurrent ulcer symptoms. One patient (Table III) had subtotal gastrectomy after previous vagotomy-pyloroplasty had failed to control the bleeding ulcer; the other four patients with recurrent ulcer symptoms have not bled again and are controlled by medical management. Perforation. Of the thirteen patients whose duodenal ulcer perforated, one died postoperatively, two died within two years after surgery (both of myocardial infarctions), and none were lost to follow-up. Six of the remaining ten patients (60 per cent) are considered excellent or good results, three patients (30 per cent) are dissatisfied with their gastrointestinal function, and one patient (10 per cent) has recurrent ulcer symptoms controlled medically. Correlation
of Type of Operation
and Results.
Table IV correlates the results of surgery with the type of operation performed. Since the majority of operations performed were truncal vagotomy-pyloroplasty, no valid comparison of this procedure with the few patients in this series who had other procedures can be made. Nevertheless, this correlation is included for completeness. Comments
The many reports which have been published comparing surgical procedures for the treatment of duodenal ulcer have greatly increased our knowledge about the effectiveness and safety of these operative procedures. From these reports, it appears that truncal vagotomy and a drainage procedure is the safest of the traditional ulcer operations with the lowest overall operative mortality, 0.5 to 1.5 per cent, but with an ulcer recurrence of approximately 10 per cent [l-9,12-14]. Truncal vagotomy-antrectomy has a higher operative mortality, 2.0 to 3.0 per cent, but is probably the most effective ulcer operation with an ulcer recurrence rate of approximately 3 per cent [1,3,5,7,11,13,15,16]. Recent reports evaluating se-
270
Dissatisfied 4% 6% 25% 25% 5%
(7/178) (l/16) (l/4) (l/4) (10/202)
Recurrent Ulcer Symptoms 10% 6% 25% 0% 10%
(18/178) (l/l 6) (l/4) (O/4) (20/202)
lective vagotomy and drainage or antrectomy, or proximal gastric vagotomy (highly selective vagotomy) with or without a drainage procedure give evidence that these operations show promise in being both effective and safe procedures, although their precise role and long-term results are not as yet clear [I 7-211. During the past ten to fifteen years, because of the safety of vagotomy-drainage and the fact stated so well by Wangensteen [22] that “. . . death is more serious than ulcer recurrence,” we have used vagotomy-drainage to treat the majority of our patients with duodenal ulcer disease. However, we have recognized that 10 per cent of these patients are likely to have recurrent ulcer symptoms. The problem is that we do not know how to recognize this 10 per cent of patients in advance, so that in this group a more effective operation, vagotomy-antrectomy, might be used. If we could recognize the increased risk of ulcer recurrence in advance, the slightly increased risk of operative mortality might be justified. Acid secretory studies have not helped us recognize this group of patients. Our experience, along with that of many others, has been that acid secretory studies have not been reliably predictable in correlating with the severity of the disease in the individual patient [1,2,10,14,21]. As in many laboratory tests, high acid values have been obtained in some individuals with minimal indications for surgery, and significantly lower values have been found in other patients with apparently severe ulcer disease. Acid secretory studies are subject to errors in the proper placement of the nasogastric tube; confusion as to whether overnight specimens, basal specimens, betazole (Histalog@)-stimulated, maximum histamine-stimulated, pentagastrin-stimulated, or insulin-stimulated specimens were the best indicators; delay in analysis of the collected specimens (some specimens are placed in the refrigerator and analyzed the following day); and confusion in reporting the results (mEq/liter or mEq/hour). More recently, laboratory assessment of serum gastrin levels has also begun to show a range of values
The American Journal of Surgery
and a lack of correlation with the severity of the disease, as well as confusion as to whether the gastrin levels should be obtained in the fasting or stimulated state. Since the laboratory assessment of patients with duodenal ulcer has not been reliably predictable in selecting those patients who require a larger or more effective operation, we have, in this study, turned back to the patient with the thesis that the way the ulcer disease expresses itself in any individual patient may be the best guide to the selection of the most effective operative procedure for that patient. Our initial premise was that most patients have chronic duodenal ulcer disease of some years duration reasonably well managed medically during these years by diet and antacid therapy. At some point in their experience, the ulcer becomes less manageable and more painful or interferes more with their lives. At this time the patients are willing to undergo surgery for control of what has now become an intractable duodenal ulcer. Other patients, after years of successful medical control, with repeated episodes of reactivation of the ulcer and healing by scar tissue, eventually have enough scarring of the pyloric channel or duodenum that pyloric stenosis develops and surgery is required. A few patients have a more acute or virulent expression of ulcer disease regardless of acid secretory values, and sudden episodes of bleeding or perforation occur. Our thesis was that patients with intractability or stenosis as an indication for surgery might do well after a lesser and safer operative procedure, vagotomy-drainage, whereas patients with bleeding or perforation might show a greater tendency to recurrent ulcer disease. This thesis has been only partially substantiated by this study. We have found that, although excellent or good results were obtained in 96 per cent of patients with obstruction and 82 per cent of patients with intractability, recurrent ulcer symptoms became evident in the follow-up of 4 and 11 per cent, respectively, of patients in these two groups. However, only three of 159 patients (2 per cent) required another operative procedure. These results are contrasted with those obtained in the patients with indications of hemorrhage or perforation who had excellent or good results after operation in 85 and 60 per cent of patients, respectively, and recurrent ulcer symptoms in 15 and 10 per cent of patients, respectively. In these two groups, three of forty-three patients (7 per cent) required another operative procedure. In the two groups of patients with indications of intractability and patients with perforation, dissatisfaction with gastrointestinal function was reported
Vohima 133, March 1977
in 7 and 30 per cent, respectively. This was not found, surprisingly, in any of the patients who had obstruction or hemorrhage as indications for surgery. A comparison of the types of operations performed in this series of patients cannot be adequately assessed since most of the patients had truncal vagotomy-pyloroplasty. The incidence of excellent or good results was high in the patients who had vagotomypyloroplasty (86 per cent), as it was in those patients who had vagotomy-gastrojejunostomy (88 per cent), and the incidence of patient dissatisfaction was low (4 and 6 per cent, respectively). The incidence of recurrent ulcer symptoms was 10 per cent after vagotomy-pyloroplasty and only 6 per cent after vagotomy-gastrojejunostomy. Four of the six patients who required a second operation had previous vagotomy-pyloroplasty, but only two patients had recurrent or continuing ulcer as the indication for surgery. The other indications for a second operation in this series were for obstruction due to stenosis of the pyloroplasty in two patients and for vagotomy-pyloroplasty after simple closure of a perforated ulcer in two patients. This series demonstrates that a conservative approach to the surgical management of duodenal ulcer disease is justified and that truncal vagotomy-pyloroplasty or -gastrojejunostomy is a safe operative procedure. None of the patients electively operated on died. Most patients are satisfied with the results and few are dissatisfied or have recurrent duodenal ulcers. We did not demonstrate conclusively that the symptoms of duodenal ulcer disease in the individual patient can be used alone as a guide to operative management. However, our results suggest that the indications for surgery may be one factor that will enable the surgeon to predict which patients should do well after vagotomy-drainage,or which patients might require a more aggressive surgical approach. At the present time, we are continuing a conservative operative approach for most patients with duodenal ulcer disease, trying to individualize and identify those patients who might require a more aggressive initial operation by virtue of a history of bleeding or perforation, taking into account age, sex, lifestyle, body habitus, acid secretory studies, and duration of symptoms. Summary
The present study correlates the indications for operation in 215 patients with duodenal ulcer disease with the results of operative management. The majority of patients had conservative surgery utilizing truncal vagotomy and pyloroplasty or gastrojejunostomy. None of the 194 patients operated on elec-
271
Ohme, Brawner, and Hermann
tively died and four patients died after emergency operations, for an overall operative mortality in the entire series of 1.8 per cent. The incidence of recurrent ulcer symptoms in all patients was 10 per cent. We could demonstrate only a modest correlation between indications for operation and long-term results of conservative surgical management; the indication for surgery, whether that of chronic (intractability, stenosis) or more acute (hemorrhage, perforation) ulcer disease is only moderately reliable as a predictor of long-term results. In this series of patients, those with obstructing duodenal ulcers (pyloric stenosis) had the best long-term results after conservative surgical management. References 1. Brooks JR, Dariush K, Membreno AA: Truncal vagotomy and pylaroplasty for duodenal ulcer. Arch Surg 110: 822, 1975. 2. Eisenberg MM, Woodward El?, Carson TJ, et al: Vagotomy and drainage procedure for duodenal ulcer; the results of ten years’ experience. Ann Surg 170: 317, 1969. 3. Hoerr SO, Ward JT: late results of three operations for chronic duodenal ulcer; vagotomy-gastrojejunostomy, vagotomyhemigastrectomy, vagotomy-pyloroplastysty; Interim report. Ann Surg 176: 403, 1972. 4. Elective operations performed for duodenal ulcer, with their mortality. Results of a Second Survey in Selected Ohio Hospitals by Survey Committee, Ohio Chapter, American College of Surgeons. Am J Surg 114: 427, 1967. 5. Howard RJ, Murphy WR, Humphrey EW: A prospective randomized shady of the elective surgical treatment for duodenal ulcer; two- to ten-year follow-up study. Surgery 73: 256, 1973. 6. McDonald CD, Abtahi H: Critical appraisal of vagotomy and pyloroplasty; treatment of peptic ulcer. Arch Surg 100: 414,
272
1970. 7. Price WE, Grizzle JE, Postlethwait RW, et al: Results of operation for duodenal ulcer. Surg Gynecol Obsfet 131: 233, 1970. 8. Schlicke CP, Logan A: Lessons learned from the use of vagotomy in the treatment of peptic ulcer. Am J Swg 124: 121, 1972. 9. Schofield PF, Watson-Williams EJ, Sorrel1 VF: Vagotomy and pyloric drainage for chronic duodenal ulcer. Arch Surg 95: 615,1967. 10. Robbs JV, Bank S, Marks IN, et al: Selection of operation for duodenal ulcer based on acid secretory studies; a reappraisal. Br J Surg 60: 601, 1973. 11. Smithwick RH, Farmer DA, Harrower HW: Hemigastrectomy and truncal vagotomy in the treatment of duodenal ulcer. Am JSurg 127: 631, 1974. 12. Dragstedt LR II, Lulu DJ: Truncal vagotomy and pyloroplasty; critical evaluation of one hundred cases. Am J Surg 128: 344, 1974. 13. Hoen SO: Comparative results of operations for duodenal ulcer; a twenty year personal experience. Am J Surg 125: 3, 1973. 14. Kennedy F, MacKay C. Bedi BS, et al: Truncal vagotomy and drainage for chronic duodenal ulcer disease; a controlled trial. Br Med J 2: 71, 1973. 15. Herrington JL Jr, Sawyers JL, Scott HW Jr: A 25-year experience with vagotomy-antrectomy. Arch Surg 106: 469, 1973. 16. Palumbo LT, Sharpe WS, Lulu DJ, et al: Distal antrectomy with vagectomy for duodenal ulcer. Arch Surg 100: 182, 1970. 17. Miller B, Bombeck CT, Schumer W, et al: Vagotomy limited to the parietal cell mass. Arch Surg 103: 153, 1971. 18. Amdrup E, Andersen D, Hostrup H: The Aarhus County vagotomy trial: preliminary results. Chir Gestroenterol 9: 189, 1975. 19. Hedenstedt S: Experiences of selective proximal vagotomy (SPV)--400 cases of uncomplicated and complicated ulcers during 6 years. Ghir Gestroenferol9: 205, 1975. 20. Jordan PH Jr: Parietal cell vagotomy without drainage. Arch Surg 108: 434, 7974. 21. Nyhus LM: Two decades of gastrointestinal research. Am J Surg 131: 3, 1976. 22. Wangensteen SL: Ulcer recuTence versus death in peptic ulcer surgery. Am J Surg 119: 254, 1970.
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