Clinical Outcome at 10 Years After Laparoscopic Versus Open Nissen Fundoplication

Introduction

Gastroesophageal reflux disease (GERD) is a very frequent pathology in developed countries. Laparoscopic surgery has become the elective approach for the surgical treatment of GERD in the last decade. Compared with conventional surgery, laparoscopy implies lower complication and mortality rates and a shorter hospital stay. ¹ Outcome data beyond 10 years are available for open fundoplication, describing good-to-excellent outcomes in most patients, but few studies report long-term follow-up after laparoscopic fundoplication.^2,3 The aim of this study was to compare reflux control, side effects, and patient satisfaction after laparoscopic and open Nissen fundoplications beyond 10 years.

Materials and Methods

A retrospective study of all the patients undergoing Nissen fundoplication for antireflux surgery between 1996 and 1998 at our institution was performed. Age, gender, clinical manifestations, diagnostic tests employed, surgical technique, postoperative complications, and hospital stay were analyzed. The election of open or laparoscopic approach depended on the surgeons' laparoscopic abilities (all the patients were not operated on by the same group of surgeons). To evaluate the long-term results, a personal interview (i.e., face to face) was performed between November and December 2008. A self-designed questionnaire was answered by the patients, investigating the presence of symptoms and if they continued taking proton-pump inhibitors (PPIs); postoperatively, meal size, increased abdominal meteorism, and increased flatulence were compared with status before surgery. Patients were also asked if they were able to belch and vomit. Finally, satisfaction of feeling with the intervention was investigated, based on the disappearance or, at least, improvement, of the symptoms they suffered before surgery. All these items were collected by an independent interviewer. Patients who died or were lost at follow-up were excluded from the study. This information was found in a hospital database.

Statistic analysis was performed with the informatic program, SPSS 12.0 for Windows (SPSS, Inc., Chicago, IL). Quantitative variables following a normal distribution were defined by mean and range. In non-Gaussian variables, median was used instead of mean. Qualitative variables were defined by number of cases and percentage. P < 0.05 was regarded as significant.

Results

A total of 174 fundoplications (open and laparoscopic) were completed at the institution from 1996 to 1998. During the follow-up, 5 patients were lost and 3 died. In total, 166 patients were finally included in the study (the percent follow-up was 95.4%); 88 underwent an open Nissen fundoplication (47 males and 41 women with a mean age of 52.4 years; range, 22–82) and 78 a laparoscopic approach (45 males and 33 females with a mean age of 50.8 years; range, 26–75). Preoperative clinical data were similar in both groups (Table 1). All the patients were treated with PPI or H₂-receptor antagonist for at least 1 year before surgery, with the persistence of invalidant symptomatology. Surgical technique was similar in both groups, without section of the short gastric vessels (i.e., the Nissen-Rossetti technique). Mean operation time was 142 minutes in LS and 151 in OS (NS). Complication rate was 5% for both groups, including 2 splenic lacerations (one of them required a splenectomy, while the other was conservatively managed), 1 evisceration (reoperation was necessasry), and 1 wound infection in OS, and 2 cases of pleural opening requiring a chest drain, 1 splenic lesion, and 1 gastric lesion, both requiring a conversion to open surgery, in LS. Conversion rate for LS was 4%. Median postoperative hospital stay was 9.5 days for OS and 3 days for LS (P < 0.001).

During the follow-up, 3 patients required a reoperation, 1 in the LS group and 2 in the OS (2, 3, and 5 years after the first sugery). The reason for this was uncontrolled dysphagia, though complemetary tests (i.e., barium-contrasted studies, endoscopy, and pH monitoring) do not showed stenosis of the fundoplication or persistance of the gastroesophageal reflux. Total fundoplication was correctly performed, and the surgeons prefered to convert it into Toupet fundoplication in all of the cases, rather than redoing a Nissen one. Symptomatology disappeared completely in the 3 patients.

After 10 years, 24% of the patients of OS referred occasional symptoms (e.g., heartburn or regurgitation), while in the LS group there was only 11% (P < 0.05). Further, 16% of OS take dialy PPI and 7% of LS (P < 0.05) to avoid symptomatology. Also, 3 patients having undergone an open Nissen fundoplication and 2 a laparoscopic one, referred mild dysphagia (NS), without evidence of stenosis at barium-contrasted studies, endoscopy, or pH monitoring in all.

There was no difference in meal size 10 years after surgery between both groups; more than 85% ate a full meal after surgery. Increased abdominal meteorism or flatulence, compared with that before the operation, was observed in 34% of OS and 40% of LS (NS). No significant difference was seen in the ability to belch or vomit; referring to all the patients as having belched and been able to vomit at least once in the last 10 years, though 1 laparoscopic case that had tried to belch and vomit was not able to (this patient does not present any other symptom, and postoperative endoscopy, pH monitoring, and esophageal manometry are normal).

The satisfaction rate of the patients was 96% for the OS group and 97% for the LS (NS). All the unsatisfied patients referred actual symptoms similar or even worse than before surgery. Even the patients that required a reintervention are extremely satisfied with the results.

Discussion

The goals of an antireflux operation are to achieve control of the symptoms with minimal risk and without adding any long-term side effects to the patient undergoing the procedure. The long-term efficacy after fundoplication has been questioned, reporting in some series that over 50% of postfundoplication patients continue using antireflux medication, but recent reports do not support this affirmation anymore. ⁵ In any of our groups, the amount of patients taking antireflux drugs overcomes 16%. The durability of open fundoplication has been documented, with more than 90% of patients satisfied after 10 years. ⁶ There are few reports of long-term results after laparoscopic fundoplication. Long-term reflux control has been shown to be equal to the open procedure in some studies, ⁷ but other investigators refer worse results after laparoscopic surgery, with more frequency of postoperative reflux symptoms and disabling dysphagia and less patients satisfied with the procedure in the laparoscopic group, compared to the conventional approach. ² Our results support better long-term results after laparoscopic surgery than after an open approach, with less symptomatic patients and less patients taking daily PPI; reoperation rate is higher in the open Nissen group, though this does not reach statistical significance, because it is based in only 1 patient more. More than 95% of the patients are satisfied with the performed surgery, referring the disappearance of the symptoms or at least a significative improvement of them.

Better results after laparoscopic surgery could be somehow explained because of a better exposure of the hiatus and a more comfortable dissection and performance of the fundoplication during the laparoscopic approach, while the open procedure presents bad access to the upper parts of the abdomen. ⁸ A common opinion in the past was that it is more difficult to perform the “floppy” fundoplication by a laparoscopic approach, due to its technically difficulty, ⁹ than with the open technique; but actually, this affirmation is not supported anymore with the increasing experience of the surgeons in laparoscopic techniques.^2,7

Nissen fundoplication has been associated with an incidence of dysphagia that may reach up to 10–15% of the cases. ⁹ In our series, the incidence of dysphagia was 6% in the OS group and 4% in the LS, requiring reoperation for 2 patients of the OS group and 1 of the LS. It is important to consider that in any of these patients, stenosis or recurrence of GERD could not be demonstrated with complementary tests. The dysphagia was attributed to a narrow hiatus after a 360-degree fundoplication, but recent opinions suggest that the main cause of dysphagia results from a twisting of the gastric fundus around the esophagus. The most common error in constructing the fundoplication is to grasp the anterior portion of the stomach too low on the major curvature and to pull it behind the esophagus. ¹⁰

Conclusion

Laparoscopic Nissen fundoplication appears to be at least as safe and long term in effectiveness for GERD as the open approach, with the associated postoperative advantages of a minimally invasive access. Therefore, we suggest that laparoscopic surgery should be considered the elective procedure for the surgical treatment of GERD.