COMPARISON OF LAPAROSCOPIC AND OPEN ANTIREFLUX PROCEDURES

COMPARISON OF LAPAROSCOPIC AND OPEN ANTIREFLUX PROCEDURES

V. Velanovich

Division of General Surgery, Henry Ford Hospital, Detroit, MI, USA

Introduction

Antireflux surgery was originally developed as an open operation. With the advent of laparoscopic cholestectomy, fundoplications have been modified to the laparoscopic approach. There have been at least 11 non-randomized comparisons and 6 randomized clinical trials comparing laparoscopic and open anti- reflux surgery. Overall, these studies have shown that symptomatic relief is similar between these ap- proaches. Short-term quality of life appears superior for the laparoscopic approach. However, the laparos- copic approach may also have a slightly higher com- plication and side effect rate. Nevertheless, patient satisfaction appears dependent of symptomatic relief, not the type of approach. Therefore, type of approach should be determined by patient and surgeon factors, not dogmatically applied to all patients.

Rudolph Nissen published in 1956 the landmark article pertaining to the fundoplication which now bears his name [1]. Since that time the Nissen fun- doplication has become the standard by which all other anti-reflux operations are compared. Most va- riations of anti-reflux operations have some compo- nent of either a partial or complete fundoplication.

Up until recently, the two main approaches have been the trans-abdominal approach, through some type of laparotomy, or a trans-thoracic approach, through a left posterior lateral thoracotomy. 1991 ushered in a new era of anti-reflux surgery with the first Nissen fundoplication performed through a lap- aroscopic approach [2]. Although the laparoscopic fundoplication has rightfully taken its place as a standard of care for gastroesophageal reflux disease, the open approach is still a valuable alternative to the minimally invasive approach. The purpose of this chapter will be to review the comparative data pertaining to laparoscopic and open anti-reflux sur-

gery, and to make recommendations with respect to these approaches.

Indications for antireflux surgery

Although other chapters in this book will deal with the evaluation and treatment planning of patients with gastroesophageal reflux disease, review of acceptable indications for anti-reflex surgery is still warranted.

Patients with both typical and atypical symptoms of gastroesophageal reflux disease are amendable to both the laparoscopic and open approach. The minimum requirements to determine the suitably of patients for surgery include a complete history and physical exami- nation to rule out other potential causes for symptoms (e.g., cardiac or respiratory causes), upper endoscopy primarily to rule out other sources of pathology (e.g., esophageal cancer), esophageal manometry primarily to rule out other esophageal motility disorders, and 24 hour pH-monitoring to establish the presence of pathologic reflux and symptoms index. On a selective basis, upper gastrointestinal contrast radiography and gastric emptying scintography can be used to evaluate for potential structural abnormalities, like paraesopha- geal hernia, or gastroparesis, especially if symptoms of bloating exist. Once the decision has been made to proceed with anti-reflux surgery, the surgeon must choose the approach best suited for the patient.

The majority of patients are good candidates for

a laparoscopic fundoplication, and this would be the

first choice of most surgeons experienced in this

technique. The only areas where an open approach

would be considered preferable by some authorities

to the laparoscopic approach include patient prefer-

ence, prior abdominal surgeries where extensive

intra-abdominal adhesions would be expected, large

lower esophageal sphincter length and prevalence of incomplete relaxation were also higher in the laparo- scopic group. Hospital stay was less in the laparoscopic group. Nevertheless these physiologic differences did paraesophageal hernias, extensive esophageal fore-

shortening mandating a thoracic approach although the Belsey fundoplication can be done thoracoscepi- cally, or redo fundoplication. This being said, there are many surgeons who would feel perfectly com- fortable proceeding with a laparoscopic approach despite the limitations listed above. However, it is imperative that the first choice for the patient be based on the safety and effectiveness of the tech- nique in the surgeon’s hands.

I will not go into detail as to the operative tech- niques as these are reviewed in other chapters.

Comparison of laparoscopic and open fundoplication

As with other laparoscopic operations, it has gener- ally been assumed that patients undergoing laparo- scopic fundoplication will have less pain and a faster return to normal activities. Initially there has been some question about whether a laparoscopic fundo- plication would be as effective as the open fundopli- cation in the treatment of gastroesophageal reflux disease. Therefore studies comparing the two have focused on several points. These include symptom- atic relief, complications, post-operative side effects, costs, durability of symptom relief, short and long- term quality of life.

Table 1 [3]–[13] lists studies comparing the lapa- roscopic to the open approach in a non-randomized fashion. Some of these studies are retrospective, others are prospective. Table 2 [14]–[22] lists the six studies in which report randomized prospective comparisons of the laparoscopic to the open ap- proach. In addition, Catarci et al [23], have done a very interesting evidenced based appraisal of anti- reflux operations reviewing in a strict manner the available data pertaining to anti-reflux surgery.

Peters et al [3], in 1995 compared 34 patients who underwent laparoscopic fundoplication compared to 47 who underwent open fundoplication. There was a sim- ilar outcome with respect to symptomatic improve- ment. They found that 84% of patients in both groups were “cured” or improved. However, 87% of the laparo- scopic group was satisfied with surgery, compared to 95% of open patients. Lower esophageal sphincter pressure was higher in the laparoscopic group (20.9 mm Hg vs. 12.1 in the open group). In addition

Table 2. Randomized comparisons

Study/ Year Open LAP Follow up

reference operations operations

Laine [12] 1997 55 55 12 months

Heikkinen 1999 20 22 24 months

[15], [16] 2000

Bias [1], [17] 2000 46 57 3 months

Nilsson 2000 30 30 6 months

[18]–[20] 2001 2002

Luostarinen 2001 15 13 17 months [21]

Chrysos [22] 2002 50 56 12 months Table 1. Non-randomized comparisons

Study/ Year Open oper- LAP oper- Follow-up reference ations (n) ations (n)

Peters [3] 1995 47 34 7 months

(lap) 52 months (open)

Low [4] 1995 25 5 Not

specified Rattner [5] 1995 12 74 12 months

Blomquist 1996 25 25

[6]

Blomquist 1996 28 28 N/A

[8]

Eshraghi 1998 114 157 23 months [7]

Velanovich 1999 20 60 1.5 months [9]

Rantanen 1999

27 30

[10]

Rantanen 1999

1162 3993 N/A [11]

Streets [12] 2002 33 72 25 months (lap) 31 months (open) Stewart 2004

[13]

not seem to translate into higher postoperative side effects. Rattner and Brooks [5] in 1995 also reported similar levels of patient satisfaction, with equal occur- rences of the post-operative symptoms of bloating, dysphasia and recurrent heartburn. However, these authors report that patients undergoing laparoscopic fundoplication returned to work sooner than open pa- tients, and overall monetary charges were less for the laparoscopic group. Interestingly, correction of preop- erative symptoms and lack of postoperative side effects were more accurate predictors of satisfaction then sur- gical approach. Eshraghi et al [7], reported similar intra-operative complications between laparoscopic and open anti-reflux procedures at 8%. These compli- cations included splenctomy, esophageal or gastric perforation, hemorrhage, and pneumothorax. Postop- erative complications however were higher in the open group only in the frequency of dehiscence and ventral hernia. Follow up symptoms were similar between the open and laparoscopic group with 67% of open pa- tients and 64% of laparoscopic patients completely asymptomatic. Dysphagia, recurrent reflux, nausea, pain and gas bloat occurred in less than 7% in both groups. Using a generic quality life instrument, the SF-36, as well as symptom severity instrument, the GERD - HRQL , I showed in a nonrandomized but prospective, fashion that the symptom improvement was comparable in both the laparoscopic and the open anti-reflux surgery patients [9]. In the laparoscopic group, the total GERD-HRQL score (best score 0, worst score 50) improved form 27 to 2, while in the open group, it improve from 27 to 1. However, the lap- aroscopic group had better postoperative scores in the SF-36 domains of physical functioning 80 vs. 67.5 (best score 100, worst score 0) and bodily pain 64 vs.

51.5 [7]. Similarly, Rantanen et al [10] showed similar functional outcomes between the laparoscopic and the open fundoplication groups. They found no difference in persistent dysphagia, symptoms relief, bloating, and flatulence, although a higher percentage of patients re- ported normal belching after the open fundoplication.

However, the same group in a population based study in Finland, showed that more life threatening compli- cations occurred in the laparoscopic group compared to the open group. The patients who underwent laparo- scopic fundoplication had an overall incident of 1.3%

of life threatening complications, compared to the 0.6% prevalence in open surgery. The laparoscopic

group also had higher incidents of nonfatal life threat- ening complications 1.2% vs. 0.3% in the open group. A complete cost analysis taking into account direct medi- cal cost and indirect social cost of laparoscopic and open fundoplication was done by Blomquist et al [8] in Sweden. They found that the laparoscopic approach was more cost effective, with less sick leave (9.9 days vs.

29.9 days), less direct medical cost (27,693 SEK vs.

37,482 SEK ) and less in direct medical cost (12,595 SEK vs. 37,126 SEK ). Therefore, in summary these studies show that laparoscopic fundoplication has simi- lar symptoms response rates better early quality of life and overall less cost at the expense of a slightly higher complication rates and postoperative side effects.

In reviewing the data in the randomized trials, most trails had relatively short follow-up between 6–

24 months, and comparatively few patients with a total of 187 patients randomized to the open group and 188 patients randomized to the laparoscopic over the six studies (Table 2). This probably speaks to the difficulty in conducting randomized trails in this setting. In these trials the symptomatic recur- rence rates varied from 0–10% with an average of 3.7% in the open group and 2.1% in the laparoscop- ic group. Dysphagia varied from 0–58%, with an average of 15% in the open group compared to 19%

in the laparoscopic group. Bloating was similar in both groups at around 20%. However 2.6% of pa- tients required re-operation in the laparoscopic group compared to 0.5% in the open group. Hospi- tal stay generally favored the laparoscopic group, but by only 2 days. Average sick leave generally favored the laparoscopic group, but this was still quite vari- able. Importantly, there was quite a bit of variation in operative technique, including performing a hiatal repair, use of an esophageal dilator and division of the short gastric vessels. It remains unclear whether these variations lead to differences in outcome.

Overall, the outcomes of laparoscopic versus open fundoplication are similar. Symptomatic relief is similar, post-operative complications overall are similar [24]. Population based studies, however, do suggest that there is a slightly higher incident of life threatening complication in laparoscopic group.

However, quality of life, at least in the short term, ap-

pears to favor the laparoscopic approach. However,

it should be noted that patient satisfaction is overall

mostly related to symptomatic improvement rather

[8] Blomquist AM, Lonroth H, Dalenback J, Lundell L (1998) Laparoscopic or open fundoplication? A com- plete cost analysis. Surg Endosc 12: 1209–1212 [9] Velanovich V (1999) Comparison of symptomatic and

quality of life outcomes of laparoscopic versus open anti-reflux surgery. Surgery 126: 782–789

[10] Rantanen TK, Salo JA, Salminen JT, Kellokumper H (1999) Functional outcome after laparoscopic or open Nissen fun- doplication: a follow-up study. Arch Surg 134: 240–244 [11] Rantanen TK, Salo JA, Sipponen JT (1999) Fatal and

life-threatening complications in antireflux surgery:

analysis of 5,502 operations. Br J Surg 86: 1573–1577 [12] Streats CG, Demeester SR, DeMeester TR et al (2002) Excellent quality of life after Nissen fundoplication de- pends on successful elimination of reflux symptoms and not invasiveness of the surgical approach. Ann Thorac Surg 74: 1019–1025

[13] Steward GD, Watson AJ, Lamb PJ et al (2004) Com- parison of three different procedures for antireflux sur- gery. Br J Surg 91: 724–729

[14] Laine S, Rantala A, Gullisch R et al (1997) Laparo- scopic vs. conventional Nissen fundoplication. A pro- spective randomized trail. Surg Endosc 11: 441–444 [15] Heikkinen TJ, Hakipuro K, Kovukangus P et al (1999)

Comparison of cost between laparoscopic and open Nissen fundoplication: a prospective randomized trail with 3-month follow-up. J Am Coll Surg 199: 368–376 [16] Heikkinen T, Hakipuro K, Bringman S et al (2000) Comparison of laparoscopic and open Nissen fundopli- cation of 2 years after operation. A prospective ran- domized trail. Surg Endosc 14: 1019–1023

[17] Bais JE, Bartelsman JFWM, Bonjer HJ et al (2000) Laparoscopic or conventional Nissen fundoplication for gastroesophageal reflux disease: randomized clinical trail. Lancet 355: 170–174

[18] Nilsson G, Larsson S, Johnsson F (2000) Randomized clinical trail of laparoscopic versus open fundoplication:

blind evaluation of recovery and discharge period. Br J Surg 87: 873–878

[19] Werner J, Nilsson G, Oberg S et al (2001) Short-term outcome after laparoscopic and open 360 fundoplica- tion. A prospective randomized clinical trial. Surg Endosc 15: 1124–1128

[20] Nilsson G, Larsson S, Johnsson F (2002) Randomized clinical trail of laparoscopic versus open fundoplication:

evaluation of psychological well-being and changes in everyday life from a patient perspective. Scond J Gas- troenterol 37: 385–391

[21] Luostorinen M, Virtanen J, Matikainen M et al (2001) Dysphasia and esophageal clearance after laparoscopic than to the operative approach [5], [12]. However, it

appears that the quality of life advantage of the lapa- roscopic approach fades with time. Once a year passes quality of life scores using the SF-36 instru- ment are similar between patients undergoing lapa- roscopic and open fundoplication [25]. Therefore, the true advantage of the laparoscopic approach is in earlier recovery, less early pain, and foster return to physical functioning.

In conclusion, laparoscopic anti-reflux surgery has become a mainstay in the surgical treatment of gastroesophageal reflux disease. Symptomatic relief appears to be as good with both the laparoscopic and open approach. Short term quality of life with respect to functional recovery is superior in the lapa- roscopic group, however this does wan with time, as patients in the laparoscopic and open group after a year or two post-operatively appear to have similar levels of quality of life. Therefore because one approach is not decidedly superior over another ap- proach in the long term, choice of procedures should be individualized as per the patients needs.

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