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Controlled study of the surgical treatment of duodenal ulcer
Controlled Study of the Surgical Treatment of Duodenal Ulcer Richard W. Dwight, MD, Boston, Massachusetts Eiihu M. Schimmei, MD, Boston, Massachusetts Edward 1. O’Hara, MD, Boston, Massachusetts Herbert B. Hechtman, MD, Boston, Massachusetts Lester F. Wiiiiams, MD, Boston, Massachusetts Rudolph W. Voiiman, MD, Boston, Massachusetts J. Peter Maseiii, MD, Boston, Massachusetts Willard C. Johnson, MD, Boston, Massachusetts Donald C. Nabseth, MD, Boston, Massachusetts
The optimal surgical procedure for the elective treatment of duodenal ulcer remains in doubt. Although vagotomy and drainage and vagotomy and hemigastrectomy are used most widely at present, the choice between these two procedures, on the basis of existing reports, is not clear-cut. Uncontrolled clinical studies on the operative treatment of duodenal ulcer are subject to personal bias, selection, and emotional convictions that can rarely survive critical analysis. Existing controlled studies [l-3] comparing vagotomy and drainage with vagotomy and hemigastrectomy have not been entirely conclusive. To compare these two methods of treatment a prospective study was devised in which one of these procedures was selected at random for each patient of a group of one hundred patients who qualified for elective surgical treatment of duodenal ulcer between 1966 and 1973. From the Departments of Surgery and Medicine, the Boston Veterans Administration Hospital and Tufts University and Boston Unhrersity Schools of Medicine. Boston, Massachusetts. Reprint requests should be addressed to Richard W. Dwight, MD, Surgical Service, Veterans Administration Hospital. 150 South Huntington Avenue, Boston, Massachusetts 02130. Presented at the Fifty-Fifth Annual Meeting of the New England Surgical Society, Watervilla Valley, New Hampshire, September 28-28. 1974.
374
Methods The patients were male veterans between the ages of twenty-three and seventy-eight who had one of the following indications for operation: (1) two or more episodes of hemorrhage; (2) two perforations; (3) one or more episodes of obstruction; or (4) pain that no longer responded to medical treatment. Approximately 60 per cent of the patients fell into the latter group and had lengthy histories of attacks and remissions, often including one of the complications, and justifying the term, “intractability.” All operations were elective, with an interval of at least one week after an episode of hemorrhage or obstruction and six weeks or more after closure of a perforation. When operation had been decided, usually in conjunction with the Medical Service, an augmented histamine test was performed [4]. Cards that indicated either vagotomy and drainage or vagotomy and hemigastrectomy were arranged according to a table of randomized numbers in a series of consecutively numbered, sealed envelopes. The drainage procedure included posterior gastroenterostomy or any type of pyloroplasty, and either gastroduodenostomy or gastroenterostomy after hemigastrectomy. (Figure 1.) When at laparotomy the surgeon had determined that either resection or a drainage procedure could be performed safely, the next envelope in the series was
The Amerkan
Journal of Surgery
Duodenal
Ulcer
Ftgure 1. Affefnatlve procedures for duodenal ulcer. A, vagotomy and hemJgas?trectomy: B, vagotomy and dratnage.
opened and the indicated operation performed. The case was entered in the study at that time. Fifty-one hemigastrectomies and forty-nine drainage procedures were performed. Of the hemigastrectomies, there were eighteen Billroth I and thirty-three Billroth II operations; of the drainage procedures, there were twenty-eight Heineke-Mikulicz, five Jaboulay, eight Finney, and two Wangensteen pyloroplasties and six posterior gastroenterostomies. The patients in the two groups were comparable in age, duration of symptoms, and preoperative peak acid output. In both groups the most frequent indication for surgery was intractability. Hemorrhage was next in both groups but was more prominent in the hemigastrectomy group whereas more patients with obstruction were in the drainage group. (Table I.) The patients were expected to return every three months in the first year after operation and then every six months. At each visit they were weighed and then seen by one of us who filled out a questionnaire detailing the patient’s work, bowel habits, eating habits, symptoms, and use of antacids or other medicines and alcohol, The abdomen was examined for tenderness, succussion, and solidity of the scar, blood was drawn to test for serum iron, iron-binding capacity, and hematocrit, and the patient was given a filter paper to mail back with a stool specimen for a guaiac test. The result was considered excellent when the patient had no complaints, good when there were mild gastrointestinal symptoms not affecting normal activity, and poor when there were moderate to marked symptoms that did affect his normal way of life. These symptoms included postprandial fullness, nausea, and sweating; inability to regain normal weight; and diarrhea, with ur-
Volume 129, April 1975
gency and cramps. Failure was indicated by recurrent ulcer as demonstrated by x-ray film or gastroscopy, gastric obstruction requiring reoperation, or incapacitating dumping and malnutrition. The results were evaluated by surgeons and gastroenterologists. Results The average operating time of 245 minutes for vagotomy and hemigastrectomy was significantly longer than the 170 minutes for vagotomy and drainage (p
TABLE
I
Summary
of Patients
Hemigastrectomy
____. Age at operation Range Mean Duration of symptoms Range Mean Peak acid output CmWhr) Principal indication operation Intractability Hemorrhage Obstruction Perforation
Drainage
24-65 yr 47 yr
23-78 yr 49 yr
3 mo-28 yr 16.1 yr
18 mo-35 yr 15.9 yr
261’~ 17
42 f
32 14 4 1
29 10 9 1
25
for
.__._.~_
~.._~
375
Dwight
et al
TABLE
II
Results of Treatment Vagotomy and Hemigastrectomy
Data Mortality Operating time (min) Number of patients
(ml) Number of major complications Number of minor complications Mean length of hospital stay (days) _~____
TABLE -__
III
95 per cent
16*
170 *
14*
. 001
15
4
.025
900 zk 270*
625 zk 245*
.Ol
6
2
5
8
14.5
14.5
confidence
Results According
Operation and Indication
-
P Value
0
0 240 +
transfused Volume of transfusion
* Represents
Vagotomy and Drainage
limits.
to Indication
Excellent
Good
Poor
Fair
Hemigastrectomy Intractability Hemorrhage Obstruction Perforation Total
14 5 2 221
9 7 2 ..6.
4 1
3 1
Drainage procedures Intractability Hemorrhage Obstruction Perforation
15 5 7 281
9 2 1 ;;’
...
...
.j.
.;.
2 2
3 1
...
...
.;.
.;.
Total
TABLE
IV
Postoperative
Weight Change Vagotomy and Hemigastrectomy
Number of patients weight Mean gain (pounds) Number of patients Mean loss
Vagotomy and Drainage
who gained
who
lost weight
22 (48%) 10.6 24 (52%) 17.5*
27 (60%) 13.9 16 (40%) 10.5+
*P CO.05.
during vagotomy and drainage (p <0.025), and blood replacement averaged 900 cc for hemigastrectomy and vagotomy versus 625 cc for vagotomy and drainage (p
376
cedures. There were thirteen minor complications (five after resection and eight after drainage), none of which seriously prolonged the length of stay. (Table II.) After hemigastrectomy in one patient, jejunal obstruction developed requiring resection. One patient had prolonged drainage from a duodenostomy and another had a duodenal stump leak; neither required reoperation. There were three cases of major wound sepsis. After pyloroplasty one patient had prolonged gastric retention that eventually cleared without reoperation. There was one major wound infection. Three patients never returned for follow-up visits. Two cannot be traced and the third was murdered a year and a half after operation; the results are therefore calculated on the basis of ninetyseven patients. In addition, there were ten patients (one late death) in the vagotomy and hemigastrectomy group and sixteen patients (three late deaths) in the vagotomy and drainage group who were lost to follow-up prior to their fifth year visit. The postoperativk interval was five years or more in fifty-two patients, three years in eighty patients, and at least one year in all. The results for the entire group were excellent in 52 per cent, good in 31 per cent, poor in 9 per cent, and failed in 8 per cent. After resection they were excellent in 45 per cent, good in 35 per cent, poor in 9 per cent, and failed in 8 per cent; after drainage procedures they were 58, 25, 8, and 8 per cent, respectively. Good and excellent results combined totalled about 80 per cent in each group; the drainage procedures had a slightly higher percentage of excellent results than did the resections, but none of the differences was statistically significant. Failures after hemigastrectomy included two recurrent ulcers, one stoma1 obstruction requiring reoperation, and one case of severe dumping and malnutrition. After drainage procedures there were three recurrent ulcers and one pyloric obstruction requiring reoperation. When the results are examined according to the principal indication for surgery, it is apparent that there were no failures in both groups, and no poor results when the indication for surgery was obstruction or perforation. (Table III.) The type of anastomosis after gastric resection and the type of drainage procedure did not significantly affect the results. There were no significant differences in serum iron levels, hematocrit values, and stool guaiac determinations between the two groups. The postoperative weight gain or loss is shown in Table IV. Although there was no significant dif-
The Amrkan
Journal d Surgery
Duodenal Ulcer
ference between the number of patients who gained or lost weight after resection or drainage, the mean loss of weight (17.5 pounds) after resection was significantly greater (p <0.05) than that after a drainage procedure (10.5 pounds). Comments Postlethwait [3] has stressed that the four most. important considerations in operations for duodenal ulcer are: (1) postoperative mortality; (2) severity and incidence of early postoperative complications; (3) development of recurrent peptic ulcer; (4) severity and incidence of late sequelae. Previous reports have revealed an apparent balance in the results of the two surgical procedures under study. On the one hand, elective operations involving partial gastric resection plus vagotomy have been followed by a low rate of recurrent ulceration (0.4 to 5.4 per cent) but a higher mortality (0 to 4.0 per cent); on the other hand, vagotomy plus a drainage procedure has consistently been followed by a higher rate of recurrence (2.2 to 11 per cent) but a lower mortality (0 to 2.9 per cent) [5--211. This study in which 80 per cent of the patients have been followed up three years or more after operation does not reveal significant differences in mortality or rate of recurrent ulcers between the two procedures. The tightly controlled conditions of the study, in which only candidates for elective surgery were entered and in which it was determined at operation that either procedure could be performed safely, may have resulted in this lack of significant differences in mortality and morbidity. Obviously these results cannot be duplicated in all patients requiring surgery for duodenal ulceration. However, a study devoid of mortality and significant morbidity provides a valuable background for assessing the differences in postoperative sequelae after the two operations that are being compared. Of considerable interest is the lack of significant differences in the late sequelae in the two operative groups except in weight loss. Of the patients who lost weight, those receiving vagotomy and hemigastrectomy lost significantly more weight than did those who underwent vagotomy and drainage. Of these patients, there were four in the resection group who had significant weight loss compared with only one such patient in the drainage group. An additional pertinent feature of this study was the significantly greater volume of blood used in these patients. The increased risk of transfusion reactions and transmission of hepatitis is apparent.
vollmlla 129, April 1075
Conclusions and Summary The results of a controlled study comparing vagotomy and drainage with vagotomy and hemigastrectomy in the elective surgical treatment of one hundred patients with duodenal ulcer are reported. There were no significant differences in operative mortality or postoperative complications between the groups. The duration of the operation, the number of patients requiring blood transfusion, and the volume of blood transfused were significantly greater in patients with vagotomy and hemigastrectomy. With 80 per cent of the patients three years beyond operation, the incidence of recurrent ulceration was not significantly different. The postoperative sequelae were similar in both groups of patients except in those receiving vagotomy and hemigastrectomy who had weight loss; these patients lost significantly more weight than did those who lost weight after vagotomy and drainage. Under the conditions of this study, either operative procedure can be performed without mortality and with similar results. Since there appears to be no specific advantage with resection and since nutrition is maintained better with vagotomy and drainage, the latter procedure is favored in the surgical treatment of uncomplicated duodenal ulcer.
References 1. Goligher JC, Pulvertaft CN, De Dombal FT. et al: Five to eight-year results of Leeds-York controlled BitI of elective surgery for duodenal ulcer. Br A&d J 2: 78 1, 1966. 2. Jordan PH Jr, Condon RE: A prospective evaluation of vagotomy-pylorophsty and vagotomy-antrectomy for treatment of duodenal ulcer. Ann Surg 180: 259, 1974. 3. Postlethwait RW: Five year follow-up results of operations for duodenal ulcer. Surg Gyneco/ Obstet 137: 387, 1973. 4. Kay AW: Effect of large doses of histamine on gastric secretion of HCI. &M&J 2: 77, 1953. 5. Gorgher JC, Pulvertaft CN, De Dombal FT. et al: Clinical comparison of vagotomy and pyloroplasty wtth other forms of elective surgery for duodenal ulcer. Br ii&d J 2: 787, 1968. 6. Herrington JL: Current operations for duodenal ulcer. Curr Probl Surg Chicago, Year Book Medical, July 1972, p 1. 7. Hamilton JE, Harbrecht PJ, Robbins RE, et al: A comparative study of vagotomy and emptying procedure versus subtotal aastrectomv used afternatelv in the treatment of duode&l ulcer. A& Surg 153: 934: 1961. 8. Scott HW Jr, Sawyers JL, Gobbel WG Jr, et al: Definitive surgical treatment-in duodenal ulcer disease. Curr Probl Surg Chicago, Year Book Medical, October 1968, p 1. 9. Thoroughman JC, Walker LG Jr, Raft D: A review of 504 patients with peptic ulcer treated by hemigastrectomy and vagotomy. Surg Gynecol Obstet 119: 257, 1954. 10. Mead PH: Experience with pyloroplasty and vagotomy. A review of 164 cases. Am J Surg 114: 910, 1967.
377
Dwight et al
11. Weinberg JA. Stempien SJ, Movius HJ, et al: Vagotomy and pyloroplasty in the treatment of duodenal ulcer. Am J Surg 92: 202, 1956. 12. Small WT, Jahadi MR: Pyloroplasty and vagotomy for duodenal ulcer. A four to eleven year follow-up study. Am J Surg 119: 372, 1970. 13. Wray RC Jr, Wangensteen SL: Results of vagotomy and pyloroplasty for peptic ulcer. Surgery 66: 502. 1969. 14. McDonald Go. Abtahi H: Critical appraisal of vagotomy and pyloropiasty. Treatment of peptic ulcer. Arch Surg 100: 414.1970. 15. Ochsner A. Zehnder PR, Trammel1 SW: The surgical treatment of peptic ulcer: a critical analysis of results from subtotal gastrectomy and from vagotomy plus partial gastrectomy. Surgery67: 1017, 1970. 16. Palumbo LT. Sharpe WS, Lulu DJ, et al: Distal antrectomy with vagectomy for duodenal ulcer: sixteen-year review of our results in 510 cases. Arch Surg 100: 182. 1970. 17. Judd DR. Starkloff GB. Morioka W, et al: Vagotomy and drainage procedures for duodenal ulcer. Incidence and effect of incomplete vagal section. Arch Surg 102: 242, 1971. 18. Harkins HN, Jesseph JE, Stevenson JK, et al: The “combined” operation for peptic ulcer. Arch Surg 80: 743, 1960. 19. Evans RH, Zajtchuk R, Menguy R: Role of vagotomy and gastric drainage in the surgical treatment of duodenal ulcer. Results of a ten-year experience at the University of Chicago hospitals. Surg Clin North Am 47: 141, 1967. 20. Eisenberg MM, Woodward RR, Carson TJ, et al: Vagotomy and drainage procedure for duodenal ulcer. Ann Surg 170: 317, 1960. 2 1. Farmer DA, Harrower HW. Smithwick RH: The choice of surgery in peptic ulcer disease. Am J Surg 120: 295, 1970.
Discussion John Goligher (Leeds, England): It is always very pleasant to be asked to comment on a report that confirms one’s own previous observations on the subject. Doctor Dwight and his colleagues in their study had essentially the same results we did in the Leeds-York trial of much larger series of cases followed up much longer, namely, that there is no statistically significant difference between the results of vagotomy and hemigastrectomy and those of vagotomy and drainage. I would like to emphasize two points, however. The first is that all these controlled trials, like Doctor Dwight’s and ours, to be ethically conducted, have an escape clause whereby if laparotomy reveals a very fixed duodenal ulcer of the posterior wall that is likely to give rise to technical difficulties and dangers if submitted to resection, the surgeon is allowed to reject the case from the trial. For this reason, these trials do not accurately reflect the greater intrinsic hazards of resectional procedures as compared with vagotomy and drainage. I am sure that if resectional operations, such as antrectomy with vagotomy or subtotal gastrectomy, were used routinely in all cases, there would be more deaths than there are after vagotomy and drainage. I am convinced, therefore, that if this operation is to be used in ordinary surgical practice, its application should be strictly selective and it should not be employed in patients who might produce difficult technical problems.
378
The second point is that after all of the standard operations for duodenal ulcer, there are, in addition to the 6 to 10 per cent of frank failures, quite a number of patients whose result is marred by troublesome syndromes after gastric surgery such as severe dumping, diarrhea, and bilious vomiting. In Doctor Dwight’s series, the incidence of these indifferent results was about 8 to 10 per cent. In our experience in the Leeds-York trial and in a follow-up study of hundreds of patients with these various operations, we have consistently found a higher number of such moderate results, usually about 14 to 17 per cent. If we combine these cases of indifferent results with our outright failures, we are left with a solid core of about 20 to 25 per cent of patients who have undergone standard operations for duodenal ulcer who are not really a great credit to the surgeon. We should not be complacent about these results; there is scope for further improvement in the elective surgical treatment of this condition. For this reason we in my Department in Leeds are endeavoring to improve our results still further. In the last four and a half years we have been trying out the new operation of parietal cell (or highly selective) vagotomy. This procedure has the great advantage of eliminating the need for gastric drainage, to which a lot of the side effects of gastric surgery are probably attributable, and of keeping intervention truly minimal. We have bad no operative mortality in over 300 patients with duodenal ulcer, no significant trouble with emptying of the stomach afterwards, and very good over-all functional results, which in many’ ways are better than those after any other elective surgical procedure for duodenal ulcer. We have only been following up the patients treated by this operation for between six months and five years; most of these patients have been managed in the last two or three years. Clearly this information does not provide a satisfactory basis for a final assessment of the value of highly selective vagotomy without drainage. However, our results to date have been distinctly encouraging and we propose to continue this practice and study. Cynics say we are pursuing a mirage; maybe we are, but I doubt it. I think this operation will establish itself in the end. Marshall K. Bartlett (Boston, Mass): The appeal of superselective vagotomy is very exciting, and we are all watching the results very carefully. Professor Goligher is one of the real leaders in this field. Perhaps this operation will replace the two procedures that the current study has evaluated. Only more time and experience will tell. In the meanwhile, we have to’ decide which of the other two procedures to use. The one unique feature of the present study compared with the other prospective studies to which Doctor Dwight referred is that the choice of procedure was not made until after the abdomen had been explored. Therefore, unless the anatomy was reasonable in terms of both the vagotomy and the duodenum, the case would not be considered in this se-
The Amwkan Joemal et Surgery
Duodenal Ulcer
ries. 1 would like to ask Doctor Dwight approximately how many patients were excluded on that basis and what procedure they underwent. What effect would this particular unique feature have on the results in this series? Since there is no basis for exact comparison, my comments can only be speculative and will involve some degree of personal prejudice. Please accept them as such. As for mortality, this study shows that resection takes longer, requires replacement of more blood with its various potential complications, and, if you choose this operation long enough and often enough, has a higher risk than does a shorter operation with less blood replacement. The incidence of postoperative complications for these two procedures is probably going to remain about the same. There was more wound sepsis in cases of resection than in the others, but the difference was not great. How about the incidence of subsequent ulcer? I believe we are going to have a few more cases of ulcer after vagotomy and drainage because we are occasionally protected from poor vagotomy by having removed the antrum. Resection, therefore, is probably going to have a somewhat lower incidence of subsequent ulceration. One thing that stands out in this report is that the real problem for the surgeon involves the duodenum. We must treat it with respect in choosing the operation in order to keep the risk as low as possible. In the matter of weight loss, I am sure that there will be some advantage for drainage over resection. I would like to ask Doctor Dwight whether he could detect any relation between weight loss in some of these patients and the amount of stomach resected. To me, the word, “hemigastrectomy,” has been all-inclusive, and the ex-
volune 129, Apd 1975
tent of resection has varied a good deal in different hands, just as “subtotal” gastrectomy always did. John Brooks (Boston, Mass): We agree with the philosophy of Doctor Dwight and his coworkers. In reviewing our cases of vagotomy and pyloroplasty for duodenal ulcer, we found an over-all incidence of recurrence of 3.6 per cent. When these cases were divided into elective and emergency cases, there was quite a discrepancy in the recurrence figures. One hundred sixty-five patients who underwent elective surgery for duodenal ulcer were followed up an average of four and a half years, and all for at least two years. The recurrence rate in these patients was 1.8 per cent. In the group with bleeding there was a recurrence rate of 9.2 per cent which is significantly higher than that of the elective group. Obviously there is still a difference of opinion over vagotomy and pyloroplasty or vagotomy and antrectomy as the treatment of choice for duodenal ulcer. Most surgeons, however, believe that vagotomy and pyloroplasty are indicated for the acutely bleeding duodenal ulcer, particularly in a person who is elderly and debilitated. Even though the recurrence rate is higher, the mortality is significantly less. R. W. Dwight (closing): I would like to thank Professor Goligher, Doctor Bartlett, and Doctor Brooks for their discussion. In answer to Doctor Bartlett, we did not keep track of the patients who were considered for the study and then rejected because the duodenum presented a difficult problem. We should have; the findings would have been interesting. I cannot answer his other question as we have not checked on how much of the stomach was resected in the patients who lost weight.
379
The optimal surgical procedure for the elective treatment of duodenal ulcer remains in doubt. Although vagotomy and drainage and vagotomy and hemigastrectomy are used most widely at present, the choice between these two procedures, on the basis of existing reports, is not clear-cut. Uncontrolled clinical studies on the operative treatment of duodenal ulcer are subject to personal bias, selection, and emotional convictions that can rarely survive critical analysis. Existing controlled studies [l-3] comparing vagotomy and drainage with vagotomy and hemigastrectomy have not been entirely conclusive. To compare these two methods of treatment a prospective study was devised in which one of these procedures was selected at random for each patient of a group of one hundred patients who qualified for elective surgical treatment of duodenal ulcer between 1966 and 1973. From the Departments of Surgery and Medicine, the Boston Veterans Administration Hospital and Tufts University and Boston Unhrersity Schools of Medicine. Boston, Massachusetts. Reprint requests should be addressed to Richard W. Dwight, MD, Surgical Service, Veterans Administration Hospital. 150 South Huntington Avenue, Boston, Massachusetts 02130. Presented at the Fifty-Fifth Annual Meeting of the New England Surgical Society, Watervilla Valley, New Hampshire, September 28-28. 1974.
374
Methods The patients were male veterans between the ages of twenty-three and seventy-eight who had one of the following indications for operation: (1) two or more episodes of hemorrhage; (2) two perforations; (3) one or more episodes of obstruction; or (4) pain that no longer responded to medical treatment. Approximately 60 per cent of the patients fell into the latter group and had lengthy histories of attacks and remissions, often including one of the complications, and justifying the term, “intractability.” All operations were elective, with an interval of at least one week after an episode of hemorrhage or obstruction and six weeks or more after closure of a perforation. When operation had been decided, usually in conjunction with the Medical Service, an augmented histamine test was performed [4]. Cards that indicated either vagotomy and drainage or vagotomy and hemigastrectomy were arranged according to a table of randomized numbers in a series of consecutively numbered, sealed envelopes. The drainage procedure included posterior gastroenterostomy or any type of pyloroplasty, and either gastroduodenostomy or gastroenterostomy after hemigastrectomy. (Figure 1.) When at laparotomy the surgeon had determined that either resection or a drainage procedure could be performed safely, the next envelope in the series was
The Amerkan
Journal of Surgery
Duodenal
Ulcer
Ftgure 1. Affefnatlve procedures for duodenal ulcer. A, vagotomy and hemJgas?trectomy: B, vagotomy and dratnage.
opened and the indicated operation performed. The case was entered in the study at that time. Fifty-one hemigastrectomies and forty-nine drainage procedures were performed. Of the hemigastrectomies, there were eighteen Billroth I and thirty-three Billroth II operations; of the drainage procedures, there were twenty-eight Heineke-Mikulicz, five Jaboulay, eight Finney, and two Wangensteen pyloroplasties and six posterior gastroenterostomies. The patients in the two groups were comparable in age, duration of symptoms, and preoperative peak acid output. In both groups the most frequent indication for surgery was intractability. Hemorrhage was next in both groups but was more prominent in the hemigastrectomy group whereas more patients with obstruction were in the drainage group. (Table I.) The patients were expected to return every three months in the first year after operation and then every six months. At each visit they were weighed and then seen by one of us who filled out a questionnaire detailing the patient’s work, bowel habits, eating habits, symptoms, and use of antacids or other medicines and alcohol, The abdomen was examined for tenderness, succussion, and solidity of the scar, blood was drawn to test for serum iron, iron-binding capacity, and hematocrit, and the patient was given a filter paper to mail back with a stool specimen for a guaiac test. The result was considered excellent when the patient had no complaints, good when there were mild gastrointestinal symptoms not affecting normal activity, and poor when there were moderate to marked symptoms that did affect his normal way of life. These symptoms included postprandial fullness, nausea, and sweating; inability to regain normal weight; and diarrhea, with ur-
Volume 129, April 1975
gency and cramps. Failure was indicated by recurrent ulcer as demonstrated by x-ray film or gastroscopy, gastric obstruction requiring reoperation, or incapacitating dumping and malnutrition. The results were evaluated by surgeons and gastroenterologists. Results The average operating time of 245 minutes for vagotomy and hemigastrectomy was significantly longer than the 170 minutes for vagotomy and drainage (p
TABLE
I
Summary
of Patients
Hemigastrectomy
____. Age at operation Range Mean Duration of symptoms Range Mean Peak acid output CmWhr) Principal indication operation Intractability Hemorrhage Obstruction Perforation
Drainage
24-65 yr 47 yr
23-78 yr 49 yr
3 mo-28 yr 16.1 yr
18 mo-35 yr 15.9 yr
261’~ 17
42 f
32 14 4 1
29 10 9 1
25
for
.__._.~_
~.._~
375
Dwight
et al
TABLE
II
Results of Treatment Vagotomy and Hemigastrectomy
Data Mortality Operating time (min) Number of patients
(ml) Number of major complications Number of minor complications Mean length of hospital stay (days) _~____
TABLE -__
III
95 per cent
16*
170 *
14*
. 001
15
4
.025
900 zk 270*
625 zk 245*
.Ol
6
2
5
8
14.5
14.5
confidence
Results According
Operation and Indication
-
P Value
0
0 240 +
transfused Volume of transfusion
* Represents
Vagotomy and Drainage
limits.
to Indication
Excellent
Good
Poor
Fair
Hemigastrectomy Intractability Hemorrhage Obstruction Perforation Total
14 5 2 221
9 7 2 ..6.
4 1
3 1
Drainage procedures Intractability Hemorrhage Obstruction Perforation
15 5 7 281
9 2 1 ;;’
...
...
.j.
.;.
2 2
3 1
...
...
.;.
.;.
Total
TABLE
IV
Postoperative
Weight Change Vagotomy and Hemigastrectomy
Number of patients weight Mean gain (pounds) Number of patients Mean loss
Vagotomy and Drainage
who gained
who
lost weight
22 (48%) 10.6 24 (52%) 17.5*
27 (60%) 13.9 16 (40%) 10.5+
*P CO.05.
during vagotomy and drainage (p <0.025), and blood replacement averaged 900 cc for hemigastrectomy and vagotomy versus 625 cc for vagotomy and drainage (p
376
cedures. There were thirteen minor complications (five after resection and eight after drainage), none of which seriously prolonged the length of stay. (Table II.) After hemigastrectomy in one patient, jejunal obstruction developed requiring resection. One patient had prolonged drainage from a duodenostomy and another had a duodenal stump leak; neither required reoperation. There were three cases of major wound sepsis. After pyloroplasty one patient had prolonged gastric retention that eventually cleared without reoperation. There was one major wound infection. Three patients never returned for follow-up visits. Two cannot be traced and the third was murdered a year and a half after operation; the results are therefore calculated on the basis of ninetyseven patients. In addition, there were ten patients (one late death) in the vagotomy and hemigastrectomy group and sixteen patients (three late deaths) in the vagotomy and drainage group who were lost to follow-up prior to their fifth year visit. The postoperativk interval was five years or more in fifty-two patients, three years in eighty patients, and at least one year in all. The results for the entire group were excellent in 52 per cent, good in 31 per cent, poor in 9 per cent, and failed in 8 per cent. After resection they were excellent in 45 per cent, good in 35 per cent, poor in 9 per cent, and failed in 8 per cent; after drainage procedures they were 58, 25, 8, and 8 per cent, respectively. Good and excellent results combined totalled about 80 per cent in each group; the drainage procedures had a slightly higher percentage of excellent results than did the resections, but none of the differences was statistically significant. Failures after hemigastrectomy included two recurrent ulcers, one stoma1 obstruction requiring reoperation, and one case of severe dumping and malnutrition. After drainage procedures there were three recurrent ulcers and one pyloric obstruction requiring reoperation. When the results are examined according to the principal indication for surgery, it is apparent that there were no failures in both groups, and no poor results when the indication for surgery was obstruction or perforation. (Table III.) The type of anastomosis after gastric resection and the type of drainage procedure did not significantly affect the results. There were no significant differences in serum iron levels, hematocrit values, and stool guaiac determinations between the two groups. The postoperative weight gain or loss is shown in Table IV. Although there was no significant dif-
The Amrkan
Journal d Surgery
Duodenal Ulcer
ference between the number of patients who gained or lost weight after resection or drainage, the mean loss of weight (17.5 pounds) after resection was significantly greater (p <0.05) than that after a drainage procedure (10.5 pounds). Comments Postlethwait [3] has stressed that the four most. important considerations in operations for duodenal ulcer are: (1) postoperative mortality; (2) severity and incidence of early postoperative complications; (3) development of recurrent peptic ulcer; (4) severity and incidence of late sequelae. Previous reports have revealed an apparent balance in the results of the two surgical procedures under study. On the one hand, elective operations involving partial gastric resection plus vagotomy have been followed by a low rate of recurrent ulceration (0.4 to 5.4 per cent) but a higher mortality (0 to 4.0 per cent); on the other hand, vagotomy plus a drainage procedure has consistently been followed by a higher rate of recurrence (2.2 to 11 per cent) but a lower mortality (0 to 2.9 per cent) [5--211. This study in which 80 per cent of the patients have been followed up three years or more after operation does not reveal significant differences in mortality or rate of recurrent ulcers between the two procedures. The tightly controlled conditions of the study, in which only candidates for elective surgery were entered and in which it was determined at operation that either procedure could be performed safely, may have resulted in this lack of significant differences in mortality and morbidity. Obviously these results cannot be duplicated in all patients requiring surgery for duodenal ulceration. However, a study devoid of mortality and significant morbidity provides a valuable background for assessing the differences in postoperative sequelae after the two operations that are being compared. Of considerable interest is the lack of significant differences in the late sequelae in the two operative groups except in weight loss. Of the patients who lost weight, those receiving vagotomy and hemigastrectomy lost significantly more weight than did those who underwent vagotomy and drainage. Of these patients, there were four in the resection group who had significant weight loss compared with only one such patient in the drainage group. An additional pertinent feature of this study was the significantly greater volume of blood used in these patients. The increased risk of transfusion reactions and transmission of hepatitis is apparent.
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Conclusions and Summary The results of a controlled study comparing vagotomy and drainage with vagotomy and hemigastrectomy in the elective surgical treatment of one hundred patients with duodenal ulcer are reported. There were no significant differences in operative mortality or postoperative complications between the groups. The duration of the operation, the number of patients requiring blood transfusion, and the volume of blood transfused were significantly greater in patients with vagotomy and hemigastrectomy. With 80 per cent of the patients three years beyond operation, the incidence of recurrent ulceration was not significantly different. The postoperative sequelae were similar in both groups of patients except in those receiving vagotomy and hemigastrectomy who had weight loss; these patients lost significantly more weight than did those who lost weight after vagotomy and drainage. Under the conditions of this study, either operative procedure can be performed without mortality and with similar results. Since there appears to be no specific advantage with resection and since nutrition is maintained better with vagotomy and drainage, the latter procedure is favored in the surgical treatment of uncomplicated duodenal ulcer.
References 1. Goligher JC, Pulvertaft CN, De Dombal FT. et al: Five to eight-year results of Leeds-York controlled BitI of elective surgery for duodenal ulcer. Br A&d J 2: 78 1, 1966. 2. Jordan PH Jr, Condon RE: A prospective evaluation of vagotomy-pylorophsty and vagotomy-antrectomy for treatment of duodenal ulcer. Ann Surg 180: 259, 1974. 3. Postlethwait RW: Five year follow-up results of operations for duodenal ulcer. Surg Gyneco/ Obstet 137: 387, 1973. 4. Kay AW: Effect of large doses of histamine on gastric secretion of HCI. &M&J 2: 77, 1953. 5. Gorgher JC, Pulvertaft CN, De Dombal FT. et al: Clinical comparison of vagotomy and pyloroplasty wtth other forms of elective surgery for duodenal ulcer. Br ii&d J 2: 787, 1968. 6. Herrington JL: Current operations for duodenal ulcer. Curr Probl Surg Chicago, Year Book Medical, July 1972, p 1. 7. Hamilton JE, Harbrecht PJ, Robbins RE, et al: A comparative study of vagotomy and emptying procedure versus subtotal aastrectomv used afternatelv in the treatment of duode&l ulcer. A& Surg 153: 934: 1961. 8. Scott HW Jr, Sawyers JL, Gobbel WG Jr, et al: Definitive surgical treatment-in duodenal ulcer disease. Curr Probl Surg Chicago, Year Book Medical, October 1968, p 1. 9. Thoroughman JC, Walker LG Jr, Raft D: A review of 504 patients with peptic ulcer treated by hemigastrectomy and vagotomy. Surg Gynecol Obstet 119: 257, 1954. 10. Mead PH: Experience with pyloroplasty and vagotomy. A review of 164 cases. Am J Surg 114: 910, 1967.
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11. Weinberg JA. Stempien SJ, Movius HJ, et al: Vagotomy and pyloroplasty in the treatment of duodenal ulcer. Am J Surg 92: 202, 1956. 12. Small WT, Jahadi MR: Pyloroplasty and vagotomy for duodenal ulcer. A four to eleven year follow-up study. Am J Surg 119: 372, 1970. 13. Wray RC Jr, Wangensteen SL: Results of vagotomy and pyloroplasty for peptic ulcer. Surgery 66: 502. 1969. 14. McDonald Go. Abtahi H: Critical appraisal of vagotomy and pyloropiasty. Treatment of peptic ulcer. Arch Surg 100: 414.1970. 15. Ochsner A. Zehnder PR, Trammel1 SW: The surgical treatment of peptic ulcer: a critical analysis of results from subtotal gastrectomy and from vagotomy plus partial gastrectomy. Surgery67: 1017, 1970. 16. Palumbo LT. Sharpe WS, Lulu DJ, et al: Distal antrectomy with vagectomy for duodenal ulcer: sixteen-year review of our results in 510 cases. Arch Surg 100: 182. 1970. 17. Judd DR. Starkloff GB. Morioka W, et al: Vagotomy and drainage procedures for duodenal ulcer. Incidence and effect of incomplete vagal section. Arch Surg 102: 242, 1971. 18. Harkins HN, Jesseph JE, Stevenson JK, et al: The “combined” operation for peptic ulcer. Arch Surg 80: 743, 1960. 19. Evans RH, Zajtchuk R, Menguy R: Role of vagotomy and gastric drainage in the surgical treatment of duodenal ulcer. Results of a ten-year experience at the University of Chicago hospitals. Surg Clin North Am 47: 141, 1967. 20. Eisenberg MM, Woodward RR, Carson TJ, et al: Vagotomy and drainage procedure for duodenal ulcer. Ann Surg 170: 317, 1960. 2 1. Farmer DA, Harrower HW. Smithwick RH: The choice of surgery in peptic ulcer disease. Am J Surg 120: 295, 1970.
Discussion John Goligher (Leeds, England): It is always very pleasant to be asked to comment on a report that confirms one’s own previous observations on the subject. Doctor Dwight and his colleagues in their study had essentially the same results we did in the Leeds-York trial of much larger series of cases followed up much longer, namely, that there is no statistically significant difference between the results of vagotomy and hemigastrectomy and those of vagotomy and drainage. I would like to emphasize two points, however. The first is that all these controlled trials, like Doctor Dwight’s and ours, to be ethically conducted, have an escape clause whereby if laparotomy reveals a very fixed duodenal ulcer of the posterior wall that is likely to give rise to technical difficulties and dangers if submitted to resection, the surgeon is allowed to reject the case from the trial. For this reason, these trials do not accurately reflect the greater intrinsic hazards of resectional procedures as compared with vagotomy and drainage. I am sure that if resectional operations, such as antrectomy with vagotomy or subtotal gastrectomy, were used routinely in all cases, there would be more deaths than there are after vagotomy and drainage. I am convinced, therefore, that if this operation is to be used in ordinary surgical practice, its application should be strictly selective and it should not be employed in patients who might produce difficult technical problems.
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The second point is that after all of the standard operations for duodenal ulcer, there are, in addition to the 6 to 10 per cent of frank failures, quite a number of patients whose result is marred by troublesome syndromes after gastric surgery such as severe dumping, diarrhea, and bilious vomiting. In Doctor Dwight’s series, the incidence of these indifferent results was about 8 to 10 per cent. In our experience in the Leeds-York trial and in a follow-up study of hundreds of patients with these various operations, we have consistently found a higher number of such moderate results, usually about 14 to 17 per cent. If we combine these cases of indifferent results with our outright failures, we are left with a solid core of about 20 to 25 per cent of patients who have undergone standard operations for duodenal ulcer who are not really a great credit to the surgeon. We should not be complacent about these results; there is scope for further improvement in the elective surgical treatment of this condition. For this reason we in my Department in Leeds are endeavoring to improve our results still further. In the last four and a half years we have been trying out the new operation of parietal cell (or highly selective) vagotomy. This procedure has the great advantage of eliminating the need for gastric drainage, to which a lot of the side effects of gastric surgery are probably attributable, and of keeping intervention truly minimal. We have bad no operative mortality in over 300 patients with duodenal ulcer, no significant trouble with emptying of the stomach afterwards, and very good over-all functional results, which in many’ ways are better than those after any other elective surgical procedure for duodenal ulcer. We have only been following up the patients treated by this operation for between six months and five years; most of these patients have been managed in the last two or three years. Clearly this information does not provide a satisfactory basis for a final assessment of the value of highly selective vagotomy without drainage. However, our results to date have been distinctly encouraging and we propose to continue this practice and study. Cynics say we are pursuing a mirage; maybe we are, but I doubt it. I think this operation will establish itself in the end. Marshall K. Bartlett (Boston, Mass): The appeal of superselective vagotomy is very exciting, and we are all watching the results very carefully. Professor Goligher is one of the real leaders in this field. Perhaps this operation will replace the two procedures that the current study has evaluated. Only more time and experience will tell. In the meanwhile, we have to’ decide which of the other two procedures to use. The one unique feature of the present study compared with the other prospective studies to which Doctor Dwight referred is that the choice of procedure was not made until after the abdomen had been explored. Therefore, unless the anatomy was reasonable in terms of both the vagotomy and the duodenum, the case would not be considered in this se-
The Amwkan Joemal et Surgery
Duodenal Ulcer
ries. 1 would like to ask Doctor Dwight approximately how many patients were excluded on that basis and what procedure they underwent. What effect would this particular unique feature have on the results in this series? Since there is no basis for exact comparison, my comments can only be speculative and will involve some degree of personal prejudice. Please accept them as such. As for mortality, this study shows that resection takes longer, requires replacement of more blood with its various potential complications, and, if you choose this operation long enough and often enough, has a higher risk than does a shorter operation with less blood replacement. The incidence of postoperative complications for these two procedures is probably going to remain about the same. There was more wound sepsis in cases of resection than in the others, but the difference was not great. How about the incidence of subsequent ulcer? I believe we are going to have a few more cases of ulcer after vagotomy and drainage because we are occasionally protected from poor vagotomy by having removed the antrum. Resection, therefore, is probably going to have a somewhat lower incidence of subsequent ulceration. One thing that stands out in this report is that the real problem for the surgeon involves the duodenum. We must treat it with respect in choosing the operation in order to keep the risk as low as possible. In the matter of weight loss, I am sure that there will be some advantage for drainage over resection. I would like to ask Doctor Dwight whether he could detect any relation between weight loss in some of these patients and the amount of stomach resected. To me, the word, “hemigastrectomy,” has been all-inclusive, and the ex-
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tent of resection has varied a good deal in different hands, just as “subtotal” gastrectomy always did. John Brooks (Boston, Mass): We agree with the philosophy of Doctor Dwight and his coworkers. In reviewing our cases of vagotomy and pyloroplasty for duodenal ulcer, we found an over-all incidence of recurrence of 3.6 per cent. When these cases were divided into elective and emergency cases, there was quite a discrepancy in the recurrence figures. One hundred sixty-five patients who underwent elective surgery for duodenal ulcer were followed up an average of four and a half years, and all for at least two years. The recurrence rate in these patients was 1.8 per cent. In the group with bleeding there was a recurrence rate of 9.2 per cent which is significantly higher than that of the elective group. Obviously there is still a difference of opinion over vagotomy and pyloroplasty or vagotomy and antrectomy as the treatment of choice for duodenal ulcer. Most surgeons, however, believe that vagotomy and pyloroplasty are indicated for the acutely bleeding duodenal ulcer, particularly in a person who is elderly and debilitated. Even though the recurrence rate is higher, the mortality is significantly less. R. W. Dwight (closing): I would like to thank Professor Goligher, Doctor Bartlett, and Doctor Brooks for their discussion. In answer to Doctor Bartlett, we did not keep track of the patients who were considered for the study and then rejected because the duodenum presented a difficult problem. We should have; the findings would have been interesting. I cannot answer his other question as we have not checked on how much of the stomach was resected in the patients who lost weight.
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