Quantitative assessment of crural closure for laparoscopic anti-reflux surgeries: A novel technique to reduce post-operative dysphagia.

BACKGROUND: Long-term dysphagia is a known complication of laparoscopic anti-reflux surgery (LARS). Of the several factors, inadequate hiatal closure is one of the major reasons for its occurrence. The aim of this study is to develop a technique for the quantitative assessment of crural closure during LARS to reduce dysphagia.
MATERIALS AND METHODS: It is an analysis of prospectively collected data of 109 patients who underwent LARS at a tertiary healthcare centre in India. To identify the adequacy of hiatal closure intraoperatively, a 7 French Fogarty catheter was used, and its balloon was inflated with 1 cc air at the repaired hiatus. This inflated balloon in the repaired hiatus following cruroplasty gives an accurate quantitative assessment of the adequate closure and adequate space for food bolus to pass without causing mechanical obstruction after hiatus repair. Pre- and post-operative 12 months' DeMeester scores and lower oesophageal sphincter (LES) pressures were calculated.
RESULTS: The patients had a significant reduction in DeMeester scores postoperatively from a mean of 68.5-12.3 (P < 0.0001). None of the patients had long-term dysphagia or the need for long-term proton-pump inhibitors. The mean LES pressures on post-operative manometry showed increase to 15.1 mmHg from a mean of 6.4 mmHg, which was statistically significant (P = 0.0001). None of the patients had a recurrence of hiatus hernia.
CONCLUSION: Quantitative assessment of adequacy for crural closure during LARS using a 7 French Fogarty catheter balloon is a novel technique which may decrease the incidence of post-operative dysphagia or intrathoracic wrap migration or recurrence of hiatus hernia.

INTRODUCTION

Gastro-oesophageal reflux disease (GERD) has a complex pathophysiology. Literature suggests that the anatomical make-up of the oesophageal hiatus has a significant role in the pathophysiology of GERD.[1] The presence of hiatus hernia is usually associated with GERD. The migration of lower oesophageal sphincter (LES) or intra-abdominal oesophagus through the enlarged oesophageal hiatus into the thorax leads to reflux of gastric contents into the oesophagus and development of GERD.[23] With the increasing experience of the surgeons and advancement in the technology in the past two decades, laparoscopic anti-reflux surgeries (LARSs) have emerged as a recognised surgical treatment option for GERD patients with satisfactory results and considerable improvement in the quality of life.[4] However, following LARS, there exist a few adverse complications, of which most commonly reported is dysphagia.[5] Immediate post-operative dysphagia is usually transient which resolves spontaneously over the next few weeks.[6] A small percentage of post-operative patients may have persistent or recurrent dysphagia. One of the causative factors for this persistent dysphagia is the mechanical obstruction of food bolus due to the tight closure of hiatal crura. If the hiatal closure is too loose, it may contribute to the recurrence of hiatus hernia.[7]

Hiatal crural closure is one of the essential elements of LARS. In this study, we emphasise the value of adequate hiatal closure with its quantitative assessment using a 7 French Fogarty catheter to ensure that the crural closure is neither too tight nor too loose.

MATERIALS AND METHODS

This study was carried out at a tertiary healthcare centre in Mumbai, India, from January 2016 to January 2019. A total of 131 LARS were carried out during this period. All the surgeries were performed by the same team with standard operative protocols. In all the patients, pre- and post-operative upper gastrointestinal (UGI) endoscopy, 24 h pH monitoring and oesophageal manometry were carried out. Postoperatively, the patients were followed up for a minimum duration of 12 months.

Inclusion and exclusion criteria

Patients of GERD undergoing LARS with normal oesophageal motility with 100% effective peristalsis on manometry and no atypical symptoms or pre-operative dysphagia were included in the study. Patients with large hiatus with intracrural distance of more than 5 cm and those requiring prosthetic mesh were excluded from the study. All the redo LARS and patients with atypical symptoms such as pre-operative dysphagia, chest pain or laryngitis were also excluded from the study.

One hundred and nine patients satisfied the inclusion criteria and were included in this study.

Innovative technique

All patients underwent laparoscopic fundoplication surgery. During initial dissection, peritoneum over the right crux was preserved to aid in better anchoring during cruroplasty. During the dissection, a large retro-oesophageal window is created, and adequate mediastinal dissection is carried out to obtain sufficient 5 cm length of the intra-abdominal oesophagus. Short gastric vessels are divided, and the posterior part of the stomach and fundus are freed. Holding the highest point of the freed fundus, the stomach is brought through the retro-oesophageal window, and the shoe-shine manoeuvre is done to see that fundus is adequately mobilised for the wrap. After the completion of dissection, cruroplasty is done, that is, the defect or widened oesophageal hiatus is closed, and both the crura are sutured together posteriorly using a non-absorbable polyfilament suture. Depending on the length of anteroposterior distance, number of sutures are decided. To identify the adequacy of closure, a 7 French Fogarty catheter is used. It is introduced in the abdominal cavity from the left mid-clavicular 10 mm port using 10–5 to 3 mm reducer after the initial cruroplasty. It is then placed at the repaired hiatus, and its balloon in the hiatus was inflated with 1 cc of air so that it just snugly fits in the repaired hiatus [Figure 1]. It gives an objective quantitative assessment of the hiatal closure rather than a subjective eyeballing for the adequacy of closure of hiatus. This inflated balloon in the repaired hiatus following cruroplasty gives an accurate quantitative assessment of the adequate closure and adequate space for food bolus to pass without causing mechanical obstruction after hiatus repair. Following cruroplasty, full and floppy posterior 360° Nissen’s wrap of 2.5 cm in length was done.

Figure 1

Calibration of repaired hiatus after cruroplasty using a 7 French Fogarty balloon catheter

Post-operative course

The patients were started on liquid diet 4 h following the surgery. For the initial 1 week, the patients were given only liquid diet to prevent the initial transient dysphagia which may occur due to post-operative oedema at the gastro-oesophageal junction. Gradually, from 2nd week onwards, the patients were started on solid food. For the assessment of the integrity of the cruroplasty and wrap and to measure the LES pressures in all the patients, post-operative UGI endoscopy, oesophageal manometry and 24 h pH monitoring were done at 24 weeks following the surgery.

RESULTS

One hundred and nine patients were included in the study (58.7% females). The average age of the patients was 45.6 ± 11.5 years (Mean ± standard deviation [SD]), and the average body mass index of the patients was 24.9 ± 1.8 (Mean ±SD). All patients had undergone pre- and post-operative manometry and UGI endoscopy. Pre-operative DeMeester score was 68.5 ± 21.1 (Mean ± SD), and post-operative DeMeester score after 6 months following surgery was 12.3 ± 4.1 (Mean ± SD). There was a statistically significant reduction of DeMeester score in the post-operative evaluation (P < 0.0001, confidence interval 95%).

The operative time was 67.2 ± 12.2 min (Mean ± SD) after the insertion of the first trocar, and the average hospital stay for patients was 48 h. In none of the patients in this study group, any prosthetic mesh was used for augmentation of the hiatal closure. The maximum intercrural distance at the end of dissection was measured before carrying out cruroplasty. Intercrural distance in this study group was found to be 3.4 cm ± 0.6 cm (Mean ± SD). All the patients who had a maximum intercrural distance of more than 5 cm were excluded from the study. The mean anteroposterior distance after dissection was 3.2 cm ± 1.1 cm. In all the patients, the quantitative assessment of the hiatal repair was done using a 7 French Fogarty catheter balloon inflated with 1 cc of air. This objective method of calibrating the hiatal repair helped in adjusting of the initial subjective repair in 8 (7.3%) patients. In 5 (4.6%) patients, one suture was removed due to tight closure, and in 3 (2.4%) patients, another suture was placed to calibrate the loose hiatal closure. None of the patients had a recurrence of hiatus hernia or had any long-term dysphagia following surgery. Seven patients had a more than usual dysphagia in the initial 2 weeks following surgery and were on liquid diet for up to 3 weeks following surgery, but at the end of 1 month, none of the patients had dysphagia. There was no requirement of long-term proton-pump inhibitors (PPIs) in the study group following LARS. In only seven patients, PPIs were continued for more than 3 weeks following the surgery. The mean LES pressures preoperatively were 6.4 ± 1.5 mmHg (Mean ± SD) which increased to 15.1 ± 1.3 mmHg (Mean ± SD) on post-operative manometry. The purpose of post-operative manometry was to assess the LES pressures following surgery and was considered as the end point of the study.

DISCUSSION

Anatomical make-up of the oesophageal hiatus has a significant role in the pathophysiology of GERD.[8] Due to the increase in the size of oesophageal hiatus, there occurs cranial migration of intra-abdominal oesophagus and LES which causes reflux and GERD.[9] Lifestyle modification and medical management with PPIs are the first line of management for GERD. Despite the use of medical therapy, 20%–30% of the patients have persistent symptoms and of these, only 1% of them opt for anti-reflux surgery.[10] One of the factors for low conversion for LARS is the fear of complication such as long-term dysphagia or gas bloat following surgery.[11]

The main aspect of a successful LARS includes achieving adequate length of the intra-abdominal oesophagus, restoring normal anatomy before the creation of wrap, adequate crural closure and a floppy wrap.[12] Granderath et al. in their study found that persistent post-operative dysphagia is more a problem due to improper hiatal closure than that of the fundic wrap.[13] Dysphagia may be due to wrap migration in the thorax because of disruption, either partial or complete, of the posterior hiatal closure. Another important cause of persistent dysphagia in a large group of post-LARS patients is due to too tight hiatal closure leading to stenosis and mechanical obstruction to food bolus.[1314]

Literature mentions the role of 56 French oesophageal bougie for intra-operative calibration at the oesophageal hiatus during LARS.[15] However, due to variation in the size of different bougies in different surgical settings, routine use of bougie did not seem to significantly affect the incidence of a long term or persistent dysphagia rates.[16] Insertion of oesophageal bougie can at times be tricky, and complications such as oesophageal or gastric perforation can occur, which ultimately increases the morbidity and can even result in mortality.[17] Since no added advantage is seen using the bougie, its routine use in LARS is not recommended.[18]

In cases of large hiatus surface area of >5 cm2, a tight posterior crural closure may result in a high incidence of disruption, and a prosthesis should be used in such scenarios.[19] In our study, we have excluded the patients with wide hiatus with intercrural distance >5 cm.

An ideal crural repair should be tight enough to prevent wrap migration but not to cause dysphagia. To assess the adequacy of crural closure performed by different surgeons, an universal scale is essential. Reardon[20] mentions 18–20 mm anteroposterior distance after crural approximation as adequate hiatal closure. This distance was calculated as it was consistent with crura approximated snugly over a 60 French oesophageal bougie. However, making a yardstick of hiatal closure on the basis of already non-standardised technique remains controversial.

A lot of debate over what is adequate closure still continues. A small case series where calibration of hiatal closure was done using a Fogarty balloon catheter showed decreased post-operative dysphagia.[21] This technique is easy and feasible to reproduce. Later, this group developed a sophisticated instrument called HiaTech for the assessment of the adequacy of cruroplasty.[22] Our study is in addition to limited existent literature on quantitative assessment of hiatal closure for adequacy during LARS. The surface area of the inflated 7 French Fogarty catheter balloon with 1 cc of air corresponds to the size of the food bolus. Hence, a crural closure which just snugly admits this balloon can be considered as adequate. No sophisticated extra instrument is required through this technique, and it is easily reproducible with similar closure even in different hands.

The collected data with pre- and post-operative investigations and clinical scoring support this technique for adequate closure of hiatus with its quantitative measurement. Patients with ineffective motility and large hiatus hernias were excluded from the study to have a uniform cohort. However, further multicentric studies with a larger sample size are needed to propose this novel technique in the standard operative protocol for LARS universally.

CONCLUSION

For the quantitative assessment of adequacy for crural closure during LARSs, using a 7 French Fogarty catheter balloon is a novel technique which may decrease the incidence of post-operative dysphagia or intrathoracic wrap migration or recurrence of hiatus hernia.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.