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ORIGINAL RESEARCH ARTICLE

Transoral fundoplication for recurrent gastro-oesophageal reflux disease following previous surgical repair

Abstract

Aim. Transoral fundoplication has been repeatedly shown to be effective in selected patients suffering from gastro-oesophageal reflux disease (GERD) refractory to conservative treatment. In this series the safety and efficacy of this approach was evaluated in a group of patients suffering from recurrent reflux problems following previous surgical antireflux treatment .

Patients and methods. From February 2009 to December 2011, 15 patients with a median age of 46.3 years (range 32– 68 years) underwent transoral fundoplication at three centres. After a median of 54 months (15–122 months) following their primary surgery, all patients were on continuous medication for GERD symptoms. Transoral fundoplication was performed using the EsophyX® or Plicator™ device. The scoring of symptoms, as well as the impact on quality of life (QOL), was evaluated with the GERD health-related quality of life (GERD-HRQL) questionnaire for typical GERD symptoms, the SF-36 questionnaire for general health status as well as the GERD Symptom Score.

Results. The median duration of the procedure was 42 min (range 30–70 min), and all patients could be discharged on the following day. The mean GERD-HRQL score at baseline during continuous proton pump inhibitor (PPI) medication was 13.4 (±2.1) and showed a statistically significant decrease to 5.7 (±1.3) at 12 months’ follow-up (P < 0.001). In accordance with this, SF-36 evaluation showed a significant improvement in physical status at 12 months’ follow-up (mean value of 50 ± 7.8 at baseline vs. 53 ± 5.2 at 12 months’ follow-up; P < 0.001). Additionally, symptom scoring improved significantly in all parameters. Twelve (80%) patients were completely off GERD medication at the last follow-up.

Conclusion. In this small group of patients with recurrent GERD following previous surgical treatment, transoral fundoplication has shown to be an effective tool to reduce symptoms and to improve QOL without the need for redo surgery, which is associated with an increased risk of morbidity.

Introduction

Surgery for refractory gastro-oesophageal reflux disease (GERD) improves symptoms and yields satisfactory results in more than 80% of patients who undergo the procedure.1–3 However, 10–15% experience recurrence of reflux symptoms, requiring continuous treatment with proton pump inhibitors (PPIs) as well as causing a significant deterioration of quality of life (QOL). Morbidity and mortality after repeat surgery can be considerable.4,5 In a recent review, intraoperative complications (mainly injury of the oesophagus or the stomach) were noted in approximately 20% of cases.4 Although symptomatic relief can be achieved by transabdominal redo fundoplication (either by the laparoscopic approach or via laparotomy), adhesions and the altered anatomy caused by the initial procedure make this surgical approach a technically demanding one.

Transoral antireflux procedures have been associated with varying degrees of success in the past.6,7 However, owing to the availability of newer instruments, the severity of reflux has been markedly improved in patients with small (< 3 cm) or no hiatal hernia.8–10 We report on a transoral approach for patients with severe GERD or refractory symptoms despite continuous PPI medication. The method is being used at three institutions from 2009 on. In the following we report the results of this procedure in patients who had previously undergone ‘conventional’ anti-reflux surgery by fundoplication.

Materials and methods

From February 2009 to December 2011, 27 patients underwent transoral fundoplication at three surgical units: two in Vienna, Austria, and one in Doha, Qatar. Fifteen of these patients had undergone fundoplication in the past for the treatment of severe GERD. Patient characteristics are listed in Table 1. Those who reported persistent GERD symptoms despite daily anti-secretory medication were deemed eligible for transoral antireflux treatment.

TABLE 1 Patient characteristics (n = 15)

Median age

46.3 (32–68) years

Gender

Male

8

Female

7

Previous surgery

Nissen

11

Toupet

4

Laparoscopy

14

Laparotomy

1

Preoperative evaluation

Preoperative assessment of patients included complete history-taking, an endoscopy of the upper GI tract and evaluation of the severity of symptoms using two standardized and validated questionnaires. Measurement of reflux by pH monitoring was discussed with every patient, but was not considered mandatory. In total, only two patients agreed to undergo this test, which demonstrated recurrent reflux in both.

The scoring of symptoms, as well as the impact on quality of life (QOL), was evaluated with the GERD health-related quality of life (GERD-HRQL) questionnaire for typical GERD symptoms,11 the SF-36 questionnaire for the general health status12 as well as the GERD symptom score.13,14

Quality of life instruments

GERD-HRQL is a validated questionnaire that specifically measures the severity of heartburn (six questions), dysphagia (two questions) and bloating (one question) and the impact of medication on daily life (one question) on a visual analogue scale (VAS) ranging from 0 (= no symptoms) to 5 (= worst symptoms). Scores ≤ 2 are indicative of rare or no symptoms. The last item of the questionnaire is focused on the patient’s general satisfaction with his or her health, and is rated ‘satisfied’, ‘neutral’ or ‘dissatisfied’. Total GERD-HRQL scores are calculated by summing responses to the 10 questions. The same six questions as those focusing on heartburn are used to obtain a score for regurgitation. A clinically significant improvement after treatment is defined as a 50% or greater reduction in scores at follow-up compared with baseline.

The SF-36 health survey analyses the general health status by evaluating physical as well as mental composite scores.

The GERD symptom score expresses the impact of the treatment on the four principal symptoms of GERD (heartburn, acid regurgitation, epigastric distress and dysphagia). Ratings are given on a scale of 0 to 4 (0 = no symptoms; 4 = very severe symptoms, i.e. symptoms that compel the patient to stay in bed or refrain from activities of normal living).

Transoral antireflux treatment

Transoral antireflux treatment was performed by the use of two available devices.

The EsophyX® device (EndoGastric solutions, Redmond, WA, USA), which has also been employed by other authors, was used in 10 patients.10,15,16 The instrument is introduced into the stomach via a flexible endoscope. The endoscope is retroflexed for visualization, and the device’s tissue mould is also retroflexed. From the tip of the device a helical retractor is advanced into the tissue and then retracted into the mould. Once the tissue mould and the helix are locked in place, an H-shaped polypropylene fastener is deployed above the Z-line so that one leg of the H is fixed in the oesophageal wall while the other extends into the gastric lumen. The procedure is usually performed in rotational fashion approximately 6–12 times, thus achieving an oesophageal gastric plication that extends above the Z-line for 3–4 cm and circumferentially to more than 270°.

An alternative instrument, the plicator (Plicator™; NDO Surgical, Inc., Mansfield, MA, USA), was used in five patients (Figures 1 and 2). This method had been repeatedly described as an effective transoral approach to treat the symptoms of GERD. Its safety and efficacy have been proven in prospective randomized trials.8,9,17

   

FIGURE 1 Plicator™ device before closing the tissue mould.

FIGURE 2 Reconstructed valve at the gastro-oesophageal junction after Plicator™ procedure.

After the procedure, patients were asked to attend follow-up investigations at 3, 6, 12 and 24 months. Quality of life as well as the severity of GERD symptoms was assessed at these investigations by interview of a blinded observer (physician or nurse). Results obtained at 12 months after the intervention were used for analysis.

Statistical methods

A non-parametric method (median, minimum and maximum values) was used for descriptive analysis of patient characteristics. QOL and the severity of symptoms were evaluated by determining mean values as well as their standard deviations. Comparison of the results determined at baseline and the values at 12 months’ follow-up was performed using a paired t-test. The level of significance was set at P < 0.01.

Results

Fifteen patients were eligible for the transoral approach after previous fundoplication which had been performed a median of 54 months previously (range 15–122 months).

Eleven (73%) patients had been treated by Nissen (360°) fundoplication while four (27%) patients had undergone fundoplication according to Toupet.

Fundoplication had been performed by the laparoscopic approach in 14 (93%) patients and via laparotomy in one (7%) patient. This last patient had undergone laparotomy and a repeat fundoplication via laparotomy 3 years later for a recurrent hiatal hernia.

All transoral procedures were performed under general anaesthesia and intubation. The median duration of the procedure was 42 min (range 30–70 min). Bleeding from the entry site of the H-shaped fasteners (the EsophyX instrument) was observed in two (13%) patients, and could be managed by keeping the tissue mould over the bleeding area closed for 1 or 2 min.

All patients were discharged the first day after the intervention and, in accordance with our protocol for fundoplication, advised to ingest only soft food for 1 week as well as continue their PPI medication for 7 days. All patients reported a sensation of a ‘sore throat’ for 2–7 days (median 3 days), which was successfully treated with oral painkillers.

Retrosternal burning when ingesting food was reported for a median period of 5 days (range 3–14 days). Dysphagia after swallowing of solid food was reported by seven patients (46%) and lasted for a median of 10 days (range 5– 18 days). Liquids and soft food were tolerated without any problems in all patients starting from the first day after surgery.

Scores of the severity of symptoms are shown in Table 2. A highly significant improvement was observed as regards heartburn, acid regurgitation, epigastric distress and dysphagia at the 12-month follow-up. Thus, the overall symptom score was significantly lower after the transoral antireflux procedure.

TABLE 2 Symptom score before and after (12 months) transoral fundoplication

Symptoms

Baseline* (n = 13)

12 months post transoral fundoplication (n = 12)

P-value

Heartburn

2.52 ± 0.8

1.35 ± 0.6

0.001

Acid regurgitation

1.98 ± 0.7

0.94 ± 0.2

0.001

Epigastric distress

1.16 ± 0.8

0.92 ± 0.6

0.001

Dysphagia

2.89 ± 0.9

1.03 ± 0.5

0.001

Overall

8.55 ± 3.2

4.24 ± 2.1

0.001

* Symptom scoring evaluated during continuous PPI medication.

GERD-HRQL scores at baseline (available in 13 patients) during continuous PPI medication showed a mean value of 13.4 (±2.1) and were statistically significant reduced to a mean of 5.7 (±1.3) at 12 months’ follow-up (data available from 12 patients) (P < 0.001).

Evaluation of SF-36 revealed a significant improvement in the physical composite scores 12 months following the procedure (Table 3).

TABLE 3 Mean values of SF-36 evaluation

Baseline under continuous medication (n = 12)

12 months post transoral fundoplication
(n = 11)

P-value

Mental Component

51 ± 3.2

51 ± 2.4

Not significant

Physical Component

50 ± 7.8

53 ± 5.2

0.001

At the last follow-up (December 2011), 12 (80%) patients were taking no GERD medication while two (13%) were taking PPI in an on-demand fashion (mainly after dietary errors), but for no longer than 1 week per month.

One patient who had already experienced a redo fundoplication by laparotomy in the past and was treated by transoral fundoplication reported recurrence of stronger symptoms 10 months after the procedure and underwent a second transoral procedure, which improved the symptoms. The last follow-up investigation of this patient was performed 3 months after the second transoral fundoplication and revealed no need for PPI medication.

Discussion

Gastro-oesophageal reflux disease (GERD) is one of the most commonly observed disorders in developed countries. It is characterized by recurrent regurgitation of acid into the oesophagus associated with heartburn, chest and epigastric pain and dysphagia. This problem affects almost 7–20% of the population, leading to a significant impairment of quality of life (QOL).

Antireflux surgery yields satisfactory results in 85% of all patients who have been refractory to previous conservative treatment; however, a proportion of patients will complain about recurring symptoms.1–5

The present series was focused on this subset of patients who had previously undergone surgery for GERD (by either Nissen or Toupet fundoplication) but had experienced recurrent symptoms leading to a marked deterioration in QOL.

Although antireflux surgery has been proven to be effective in improving symptoms caused by GERD, it is accepted that redo anti-reflux surgery is associated with a higher morbidity (and even mortality).4,5

Furnée and coworkers,4 in a review of the literature, analysed the results of 81 published studies involving 4509 patients undergoing fundoplication, and reported that intraoperative complications occurred in 21.4% and postoperative complications in 15.6%, with an overall mortality rate of 0.9%.

Symons et al.5 reported a complication rate of 14% in a recent Cochrane analysis of studies publishing the results of revisional antireflux surgery.5

Transoral incisionless fundoplication (by either the Plicator® or EsophyX® method) has repeatedly been shown to reduce the severity of GERD symptoms in selected patients.8–10 Pleskow et al.8 reported a significant reduction in symptoms as well as the need for medication in a series of 30 patients followed up for 5 years after treatment with the Plicator™ system as a primary procedure for selected patients suffering from GERD. Similarly, Testoni et al.10 were able to show a marked reduction in the need for PPI medication, with 60% (n = 21) of patients free from PPIs at 6 months after the procedure.

In our small series of 15 patients with recurrent symptoms following previous ‘transabdominal’ fundoplication, we found a statistically significant improvement in symptoms scoring and GERD-HRQL as well as SF-36 scores, which was also reflected by the fact that 80% of patients no longer needed to take PPIs at 12 months following this procedure.

Similar to the observations published by other authors,8–10,17 this method proved to be associated with only minor side-effects and all our patients were able to leave the hospital after one night.

However, it must be emphasized that the number of patients in this series has to be regarded as relatively small and the follow-up time (12 months) is too short to draw any definitive conclusions. Nonetheless, the minimally invasive nature of the transoral approach associated with the efficient reduction of symptoms (at least in the short term) makes this an interesting procedure for patients with recurrent symptoms following previous antireflux surgery and warrants further studies.

Conflict of interest

None of the authors contributing to this manuscript report any conflict of interest.

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