Prospective controlled study of gastrointestinal stapled anastomoses

Prospective Controlled Study of Gastrointestinal Stapled Anastomoses

Richard B. Reiling, MD, Dayton,

Ohio

Walter A. Reiling, Jr., MD, Dayton, Ohio William A. Bernie, MD, Dayton,

Ohio

Albert B. Huffer, MD, Dayton,

Ohio

Neal C. Perkins, MD, Dayton,

Ohio

Dan W. Elliott, MD, Dayton, Ohio

Modern gastrointestinal stapling techniques were introduced in the early 1960s by the Institute for Experimental Apparatus and Instruments in MOSccw and modified by Ravitch and associates [1,2] in the late 1960s. Since then there has been an obvious revolution in the operating theater. To the present, despite multiple reports on techniques and complications [s-7] of gastrointestinal stapling, no prospective controlled and randomized study has been performed to document the efficiency and safety of these new instruments. This is such a study. The rate of complications related to stapled anst,omoses appears consistent with the rates reported after more conventional suture techniques [J-8]. At t,he same time, the speed and efficiency of the staplers has been highly touted [2,9]. On the basis of st,aple sales, it is estimated that several hundred thousand operations using Auto Suture@ stapling techniques were performed in the United States last year. The number is increasing yearly as more experience is gained by neophyte staple-surgeons. The presumed conservation of operating time should reduce costs for the patient but, more impcrtant,ly, reduce morbidity as well. Diminished handling of the delicate bowel wall might be expected to reduce the duration of nasogastric and intravenous intubation as well as postoperative hospitalization. However, only a prospective controlled study could yield the information necessary to confirm these presumptions. Frcm the Department of Surgery. Wright State University School of Medicine and the Good Samaritan Hospital, Dayton, Ohio. Heprmt requests should be addressed to Richard B. Reiling. MD, 111 West First Street, Dayton, Ohio 45402. Presented at the 20th Annual Meeting of the Society for Surgery of the Alimentary Tract, New Orleans, Louisiana, May 22-23, 1979.

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At the time this study was undertaken, all of the authors had considerable experience with Auto Suture techniques (models TA-30, TA-55, TA-90 and GIA), as described by Ravitch [2], and were quite comfortable with their use in a variety of situations. Material and Methods All patients operated on by the authors from March 1976 to May 1977 who, at the time of surgery, were (determined to need a gastrointestinal anastomosis were included in the study. Emergency as well as elective cases were included. No cases were excluded. At the time of decision in the operating room, a sealed envelope was drawn from a randomized file by the circulating nurse and the envelope opened. A card inside indicated either conventional suture or staple technique. If a colonic or small bowel resection was proposed, elective patients were prepared with a standardized 3 day mechanical bowel cleansing routine. Neomycin-erythromycin antibiotic preparation was added on the day before surgery. The surgery was performed by five practicing general surgeons with surgical residents assisting. On occasion, the residents were the operating surgeons with staff assistance. The setting was a large community hospital affiliated with Wright State University. The conventional suture technique used was an open two-layer anastomosis with an inner layer of 3-O chromic catgut (running or interrupted) and an outer layer of interrupted :3-O silk or cotton suture. The stapler technique employed end-t,o-end anastomoses by triangulation as originally described by Ravitch and Steichen [2,7]. Variations from this everting technique were used as the case dictated, as in pyloroplasty and gastrojejunostomy during a Whipple procedure. Cases that required conversion from stapling to conventional suturing because cot technical

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TABLE I

Randomized Operations

TABLE II Comparison of Benefits in Patients With Sutured Versus Stapled Anastomoses Technique

Operation

Sutures

Staples

Gastric resection Gastroenterostomy Pyloroplasty Small bowel resection Meckel’s diverticulectomy Enterotomy Colectomy Colotomy Whipple-gastrojejunostomy Pelvic exenteration

10 3 4 4 2 1 25 0 1 0

14 4 1 3 3 1 20 1 2 1

Total

50

50

No. of patients Time in operating room (min) Postoperation hospital stay (days) Gastric suction (days) intravenous fluids (days) Operating room charges

20-

Number of Patients Number of Patlents

I

0

Sutured

50 115 12.8 4.0 8.0 $203

50 117 12.2 3.8 8.3 $342

/ m CI

_

r

m Stapled

10

Technique Sutures Staples

Benefits

IO

Stapled Sutured

‘I /I

5 :. 60

‘II 40

60

80

100

Age In Years

Figure 1. The age distribution, shown by decades, in 100 randomized patients with stapled and sutured anastomoses. There were no significant differences between the two groups.

difficulties will be described later. These cases are considered failures of the staple technique. All patients were followed up postoperatively in the customary manner by the individual surgeon. The following parameters were carefully monitored for inclusion in this study: days of nasogastric intubation, intravenous intubation and postoperative hospitalization; minor and major complications; and mortality. In addition, the actual operating time was taken from the anesthetic record, and the operating room cost was calculated by the operating room secretary. Results

The mean age of all patients with sutured anastomoses was 55.1 years (Figure I), compared with 56.8 years for stapled cases, with a range of 15 to 88 years for the former and 8 to 90 years for the latter. There were 14 (28 percent) emergency or semiemergency cases in the sutured group and 15 (30 percent) in the stapled group. Table I lists the operations performed in each group. The relatively equal distribution of gastric and

148

90

120

150 Minutes

180

240+

Figure 2. Thirty minute segments are used to show the distribution of operating times between the two groups. The total time recorded for each case was taken from the anesthesiologists’ records. The number of operations in each group requiring up to 60 minutes is shown in the first set of bars, from 60 to 60 minutes in the second set, and so on. There were no important differences between the two groups.

colonic cases in each group is notable. This distribution resulted entirely by chance, since there were no subgroups in the randomizing process. Table II summarizes the results of the parameters studied for all the cases listed in Table I. The similarity in the mean operating time of 115 minutes for the sutured group and 117 minutes for the stapled group is indeed striking; in contrast, the operating room charges were $203 and $342, respectively. The distribution of operating times for all the cases, shown in Figure 2, confirms the absence of any notable distortion in either group. Table III summarizes the same parameters for all colon anastomoses, and Table IV summarizes them for all gastric operations. Although the numbers of cases in these subgroups are low, the similarity of the results in each to those in the total series indicates that there were no important differences. Complications in the abdomen presumably related to technique are listed in Table V. These complications occurred in 16 percent of the patients with sutured anastomoses and in 18 percent of those with

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Stapled Versus Sutured Gastrointestinal

TABLE III Comparison of Benefits of Sutured Versus Stapled Anastomoses in Colon Surgery

No. of patients Time in operating room (min) Pcstoperative hospital stay (days) Gastric suction (days) Intravenous fluids (days) Operating room charges Complications No Percent

22 105 12.5 3.5 8.0 $201

20 107 12.7 2.6 6.3 $320

9 41

4 20

TABLE V Comparison of Technique-Related Complications With Sutured Versus Stapled Anastomoses

lntraoperative disruption Fistulas Paralytic ileus Abscess Wound lntraabdominal ‘rotai No Percent

3 2

3

5 1

2 1

8 16

9 18

stapled anastomoses. The latter group includes three patients with staple line disruptions that were recognized immediately during operation and corrected by, suture technique. One of the disruptions was due to a nurse’s error in which the anvil was not inserted in the stapler. The other two disruptions occurred after application of the staples, possibly as a result of the discrepancy in tissue thickness between the stomach wall and the duodenum; both occurred in gastroduodenal anastomoses. The one death in the group with stapled anastoml)ses was believed to be directly related to the staple technique. The patient died after a prolonged septic course secondary to a disruption of the Hofmeister gastrojejunostomy performed during a Whipple pancreat,oduodenectomy. Only one other intraabdominal abscess, which occurred after emergency right hemicolectomy and sutured anastomosis, was encountered. The rest of the abscesses were superficial to the fascia and occurred in 10 percent of the sutured anastomoses and in 4 percent of those stapled. Among the colon cases, there were four wound inf’ections in the sutured group and only two in the stapled group. Perhaps the stapled anastomoses are less prone to postoperative wound abscess formation (p <0.05). but the cases are too few to be sure.

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1980

Benefits

Sutures

Staples

No. of patients Time in operating room (min) Postoperative hospital stay (days) Gastric suction (days) Intravenous, Fluids (days) Operating room charges Complications No. Percent

8 133 115 33 4.8 $294

12 128 11.3 41 &?98

3 37

5 42

TABLE VR Comparison of Complications Outside the Abdomen With Sutured Versus Stapled Anastomoses .___ -.__

Technique Sutures Staples (50 patients) (50 patients)

Complication

Volume

TABLE IV Comparison of the Benefits in Gastric Surgery of Sutured Versus Stapled Anastomoses

Technique Staples Sutures

Benefits

Anastomoses

Technique Complic:ations Respiratory Cardiovascular Genitourinary Emotional Liver failure

Sutures (50 patients) __.__~~

Staples (50 patients)

~_~~~~ 1

1 3 1 1 0

0 1 1

6 12

4 8

3

1

1

Total No. Percent

~_ Death

Table ‘VI lists the remaining complications, which occurred outside the operative field, and the mortality. The distribution of these complications among the two groups was almost equal.

Comments

The objective examination of operating t.ime provided the greatest surprise in this study. The study was stopped prematurely at 100 cases because all of the authors felt that the staplers were more timeefficient. No one wanted to have to suture the bowel for the sake of controls when the staplers were available and desired. Now it is evident that, in the hands of a competent surgeon, the time required for constructing an anastomosis is a small part of the overall time required for an operation. li:nfortunatley, we did not have the foresight to measure the actual time required for the anastomosis, if such can accuratehy be measured. The scrub nurses and technicians, despite their enthusiasm for the staplers, were often less facile with the mechanical staplers than with the more familiar sutures. Some time was prohably lost due to their inexperience-a factor that may show improvement in a new study of colon surgery that is planned.

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In average hospital charges, a stapled anastomosis costs $139 more than a sutured one. However, a possibly misleading point must be clarified. The hospital in which this study was carried out computes an average suture cost into the total operating room charges for all cases, and the use of the stapler and each cartridge is charged in addition. This practice may be widespread. For a sutured anastomosis, the cost of materials is significant. Perhaps two chromic catgut sutures will be used, at a cost of $3.50 each, and three packages of silk at $7.35, for a total cost of $29.05. In contrast, two GIA staple cartridges at $44.90 each and one TA-55 at $43.10 will total $132.90. There remains an additional cost for stapling of at least $103.85. In fairness to the patient, hospital charges should reflect this fact. The results produced no evidence that less bowel handling by use of the stapler decreases the complication rate or the postoperative discomfort of the patient. The need for prolonged nasogastric and intravenous intubation appeared the same in both groups. It appears that if the surgeon is acutely aware of the hazards of poor tissue handling and uses optimal care in all cases, no advantage is provided by one anastomotic technique over the other in terms of complication rate or postoperative discomfort. Our experience dictates some caution in the use of staplers when there is a discrepancy in tissue thickness, especially between the stomach and the duodenum or jejunum. We now prefer to suture these anastomoses or add extra support by sutures when the staplers are used in gastric surgery. The technique-related complication rates of 16 percent for sutured anastomoses and 18 percent for stapled anastomoses appear high compared with the rates reported in retrospective studies [3-81. In the present study, these rates include postoperative ileus and wound infections (Table V) in order to include all possibly related problems for comparison between the two groups. If ileus and infections confined to the abdominal wall are excluded, as they have been in other studies, the complication rate is 2 percent for sutured and 8 percent for stapled anastomoses, including the three (6 percent) intraoperative disruptions immediately recognized. Interestingly, no bleeding difficulties were encountered in this study as reported by Wassner et al [8] and Fischer [IO]. The light brisk bleeding occasionally found at the time of stapled anastomosis either stopped spontaneously or was corrected with a simple chromic suture appropriately placed. Postoperatively, no significant hemorrhage occurred. Although long-term follow-up of all cases is not a part of this study, no late colon disruption occurred, 150

and no asymptomatic leaks were demonstrated by the barium contrast studies performed later. This study was devised to test the safety of gastrointestinal stapling in light of the many complications that have been reported. The controlled prospective experience reported herein appears to demonstrate that the Auto Suture gastrointestinal staplers provide a safe and effective means of performing gastrointestinal anastomoses, especially for colon and small bowel resection. On the other hand, there is no real advantage in terms of operating time or postoperative comfort and hospitalization of the patient. The addition of such staplers to the surgical armamentarium appears justified. It seems reasonable to expect that future development will bring new and better instruments, such as the recently introduced EEA (end-to-end anastomosis) stapler, which is quite effective in low anterior resection. Additional controlled studies will be needed, however, to demonstrate any reduction in the morbidity and mortality of gastrointestinal surgery with the use of the stapling technique. Summary

A controlled prospective study was carried out in a university-affiliated community hospital to evaluate the use of gastrointestinal staples compared with conventional sutures for anastomotic construction. The study included 100 randomized cases (50 sutured and 50 stapled) requiring anastomoses. Consecutive patients were accepted into the study, and no patients were excluded. There was no significant difference between the two groups in operating room time or the duration of postoperative hospitalization, nasogastric intubation or intravenous intubation. The complication rate was similar and comparable to previously published results. On three occasions, it was necessary during operation to convert from the use of staples to sutures when immediate disruption was noted at a gastroduodenal anastomosis. References 1. Ravitch MM, Rivarola A. Enteroanastomosis with an automatic stapling instrument. Surgery 1966; 59:270. 2. Ravitch MM, Steichen FM. Techniques of staple suturing in the gastrointestinal tract. Ann Surg 1972; 175:815. 3. Chassin JL, Rifkind KM, Sussman B, Kassel B, Fingaret A, Drager S, et al. The stapled gastrointestinal tract anastomosis: incidence of postoperative complications compared with the suture anastomosis. Ann Surg 1978; 188:689. 4. Gritsman JJ. Mechanical suture by Soviet apparatus in gastric resection: use in 4,000 operations. Surgery 1966; 59: 663. 5. Latimer RG, Doane WA, McKittrick JE, Shepherd AS. Automatic The American Journal of Surgery

Stapled Versus Sutured Gastrointestinal

6

7 8

9 IO

staple suturing for gastrointestinal surgery. Am J Surg 1975; 130:766. Lawson WR, Hutchinson J, Longland CJ, Hague MA. Mechanical suture methods in thoracic and abdominal surgery. Br J Surg 1977; 64:115. Steichen FM, Ravitch MM. Mechanical sutures in surgery. Br J Surg 1973; 70:191. Wassner JD, Yohai E, Heimlich HJ. Complications associated with the use of gastrointestinal stapling devices. Surgery 1977: 82:395. Ravitch MM. Staples in abdominal and thoracic surgery. Contemp Surg 1974; 4. Fischer MG. Bleeding from stapled anastomosis. Am J Surg 1976 131:745.

Discussion Robert E. Hermann (Cleveland, OH): I was surprised to find that time was not saved by the use of stapling deviI:es: I think all of us who use them selectively believe that we do save time. 1 would therefore like to ask Dr. Reiling to comment on where the extra time was used when he made a stapled anastomosis compared with a sutured one‘! 1 was a bit concerned about the mechanical failures he o( casionally sees. The authors predominantly discussed the use of’ the standard stapling devices, and I would like to mrntion the new EEA device which creates a circular SL~pled anastomosis. We have had some experience with this new device in the past year and have found it useful not only in low c’olorectal anastomoses but also in esophageal surgery, especially l’or anastomoses after proximal gastrectomy, total gastrectomy or esophagogastrectomy, or in f he ligation, transection and reanastomosis of the esophagus in patients with acutely bleeding esophageal varictas. In our early experience we have been pleased with the time saved. the safety and the results, but not the cost, of this new EEA stapling device. Edward J. Hinchey (Montreal, Canada): I have had a complication applying the TA-30 to the duodenum in the presence of’s chronic penetrating duodenal ulcer. The suture line remained intact, but, the ulcer cracked away from the pancreas. This was not recognized until later on in the procedure. whrn a hile leak was noted by a medical student who drew our attention to it,. I draw this potential compication of the stapling machine to your attention. Gilbert Hermann (Denver. CO): I would like to mention several points concerning cost. We use one staple line to perf’orm a functional end-to-end anastomosis and the co;t is at)out S:V). so I cannot go along with the proposed extra cost 111the patient of $300; it may be one tenth of that.

My other point is that we have seen a complication with thr EEA sfaplrr in an end-to-end low rectal anastomosis, in which there was a complementary colostomy constructed ahove. In this case the patient developed a severe stricture at t h(x ElSA suture line. We subsequently called the company :md asked if this had been reported, and they said yes. ‘I’hus I urge ~CJUnot to consider doing a complementary co ostomy ahove an EEA-stapled low rectal anastomosis, i8h a slr.ic.ture may develop.

Volume

139.

January

1980

Anastomoses

gram? 1 think this is a point we must consider. have the residents use it. or not?

Should

we

Richard R. Price (Salt I,ake City. IJ’I’): I have used a wide variety of stapling techniques since 1967 in over 50 dogs and well over 1,000 patients. Rapid and reliable techniques of stapling are deceptively difficult to master and requilre extensive experience to develop proficiency. makes perfect” certainly The old adage “practice applies. Although stapling accomplishes the same surgical procedure in the end as suturing, the techniques are quite different; the surgeon becomes more proficient in suturing a gastroduodenal anastomosis after 50 or 100 cases, and a similar experience is necessary for stapling. Those of you who have bravely tried stapling instruments have undoubtedly found, as I did myself and have ohserved while teaching &hers, that the first several t,imes it seemed like a disaster and took much longer to staple than it would have to suture. Indeed, many have probably h’een so frustrated that they gave up and have not used stapling since. My first question therefore is: How many surgeons were involved in this study, and how experienced were they in stapling techniques? I advise caution in interpreting data from several surgeons with limited stapling experience. A couple of years ago I briefly looked at a part of our experience at the 1,atter Day Saints Hospital., a large privat,e hospital with a close university affiliation. I have been responsible there for training attending surgeons and the house sta:tf in the use of staplers. Most procedures are performed by residents under the supervision oft he private attending surgeon. No one is allowed to use the staplers without formal instruction, including Iat) experience in dogs and supervised experience in patierlts. I reviewed the results of’ three of our busy surgeons who had become experienced in stapling in approximately 150 gastric resections before the advent of st,apling and the first 150 done after stapling. I also looked at approximately 100 sutured and 100 stapled colon resections. My lr,wn cases were excluded. These surgeons saved an average of 56 minutes doing a Hillroth 1 or II procedure, 42 minutes for vagotomy and pyloroplasty and 21 minutes f’or colon resect ion. Careful cost accounting showed that this -time saving reduced operating room costs for gastric resection t,y $36 but increased the costs for colon resection hy $19. The real savings came, however, in hospital stay, which was shortened an average of4 days for gastric resect ion and 2.8 days f’or colon resection. The complications in both the gastric and colon series were roughly the same: however, colon leaks seemed to he significantly decreased with the stapling technique Robert W. Heart, Jr. (Rochester, MN): Retrospective studies are important and interesting. but I woulcl like to compliment t,he authors on undertaking a long-overdue prospective study. We have attempted to do the same thing with the new EEA stapler. In the last year we have perf’orrncd :l randomized prospect,ive study in 68 patient_;, and we found 2: savings of approximately 5 minute>: in tinle, no 151

Reiling et al

savings in hospital cost, no significant savings in operating room costs and no apparent difference in complications. Victor W. Fazio (Cleveland, OH): The concept of Auto Suture for intestinal anastomosis is relatively new and requires a whole new discipline and training system. There is a certain bias in this study on that score alone, when comparing a relatively new with a time-honored anastomosis. No mention was made of the randomization of patients in terms of the degree of fecal loading of the colon or bowel obstruction. It has been my impression that Auto Suture anastomoses are often faster and occasionally better, as in cases in which bowel preparation is imperfect. Dr. Beart alluded to the fact that the early experience with the EEA stapler indicated no significant savings in time, yet with further experience time-saving does occur. John Sonneland (Spokane, WA): The authors of this randomized study should be complimented for their outstanding paper. However, I would have preferred that the authors gave us their time for performing the anastomoses, not for the total operation. Therefore, you may find it interesting to hear a comparison between the intestinal surgery performed by my associate Dr. Rockwell and me in Spokane. Let me preface my remarks by saying that our operating times for most operations in general surgery are approximately equal. His operative time for small bowel anastomoses, using stapling, averages 14 minutes. Mine using interrupted suture technique, averages 23 minutes. The increased cost of staples versus sutures is $62. Operating room cost, counting the time-cost of our anesthetists, is about $5 per minute. Therefore, the time-cost of the staple anastomosis is about $70 and of the sutured anastomosis, about $115. The material for stapling with the GIA and TA-30 models costs $77.50, in contrast to $15.50 for the material for a sutured anastomosis. In summary, the average cost of time and material for a stapled anastomosis is $147.50 and for a sutured anastomosis $130.50, with the latter taking 9 additional minutes to perform. Richard B. Reiling (closing): I would like to thank the discussers for their incisive comments; obviously, they raised some of the same questions we had in designing the study. I would like to point out again that this was a controlled prospective, randomized study, controlled as much as reasonably possible. There was some question about our experience in the use of staplers, and I should add that the study was carried out by five university-trained surgeons who had considerable experience with staplers since 1969. The total accumulated cases was over 500 at the time the study was undertaken, and in general we felt that we had adequate experience and facility with the instruments. The majority of operations were performed in a University Residency Program with assistance by the resi-

152

dents. On occasion, the resident was the operating surgeon; however, in this controlled study there appeared to be no significant difference in the cases done by residents and those done by staff physicians. On the other hand, Dr. Hermann questioned the place of staplers in a residency program, and we do have the philosophy that our residents must learn the conventional technique before they use the staplers. This study was carried out before the introduction of a new EEA stapler, and we are delighted to learn that Dr. Beart is doing a control study using this new stapler in low colon anastomoses. Our experience with the use of the EEA since the completion of this study is very encouraging, and we also intend to perform a control study similar to this one. Dr. Hermann questioned us about the apparent lack of difference in time needed to perform anastomoses with staples versus sutures, contrary to popular opinion. In all fairness to the United States Surgical Company, we did feel that the operating room nurses were somewhat inexperienced in handling the instruments, but on the other hand the acutal time taken by a well trained surgeon to produce an anastomosis, stapled or sutured, is very short in relation to the entire operating time. I might add that Dr. Mark Ravitch told us he could do an ileotransverse colostomy in less than 1 minute with a stapler. We find that this procedure would probably require the use of three separate staplers for the anastomosis, so that the cartridge would not have to be changed between each application as we presently do. We commend Dr. Price for his extensive experience in the use of the staplers and the triangulation method; as I mentioned, we have also had considerable experience. I would like to point out, however, that his study was not a prospective controlled study and had the obvious bias, for example, that a difficult anastomosis would probably be sutured and an easy anastomosis would probably be stapled. The value of our study lies in the fact that it is controlled. I would like to point out again that in presenting operating room costs we gave the entire operating room cost and did not imply that it cost more than $300 for the staples, but that the charge was realistically about $100 more with the use of staplers compared with the conventional suture technique. Lastly, in reply to Dr. Sonneland, we also felt that operating room time was expensive in view of the multiple costs, especially in terms of anesthesia time. We did not, however, want to embarrass our anesthesia colleagues by showing it was their cost that made the difference, and since there was virtually no time difference in our study there obviously was no anesthesia charge difference. I would like to ask the physicians who find that they need considerably less time with the use of the staplers whether they charge the patient less because of the shorter operating room time.

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