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 ¤ Introduction
 ¤  Materials and Me...
 ¤ Results
 ¤ Discussion
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 Table of Contents     
ORIGINAL ARTICLE
Year : 2012  |  Volume : 8  |  Issue : 2  |  Page : 39-44
 

A prospective nonrandomized comparison of laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in Indian population using detailed objective and subjective criteria


1 Division of Minimal Access Surgery, Department of Surgery, Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi, India
2 Division of Minimal Access Surgery, Department of Medicine, Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi, India

Date of Submission05-Jan-2011
Date of Acceptance23-Mar-2011
Date of Web Publication2-May-2012

Correspondence Address:
Pawanindra Lal
B-90, Swasthya Vihar, Delhi - 110 092
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-9941.95529

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 ¤ Abstract 

Background: Laparoscopic Nissen fundoplication (LNF) is a commonly performed procedure for the treatment of gastro esophageal reflux disease (GERD) worldwide. However, unfavourable postoperative sequel, including gas bloat and dysphagia, has encouraged surgeons to perform alternative procedures such as laparoscopic Toupet fundoplication (LTF). This prospective nonrandomized study was designed to compare LNF with LTF in patients with GERD. Materials and Methods: Hundred and ten patients symptomatic for GERD were included in the study after having received intensive acid suppression therapy for a minimum of 8 weeks. A 24-hour pH metry was done on all patients. Fifty patients having reflux on 24-hour pH metry were taken up for the surgery. Patients were further divided into group-A (LNF) and group-B (LTF). Results: The median percentage time with esophageal pH < 4 decreased from 10.18% and 12.31% preoperatively to 0.85% and 1.94% postoperatively in LNF and LTF-groups, respectively. There was a significant and comparable increase in length of lower esophageal sphincter (LES), length of intraabdominal part of LES and LES pressure at respiratory inversion point in both the groups. In LNF-group, five patients had early dysphagia that improved afterwards. There were no significant postoperative complications. Conclusion: LNF and LTF are highly effective in the management of GERD with significant improvement in symptoms and objective parameters. LNF may be associated with significantly higher incidence of short onset transient dysphagia that improves with time. Patients in both the groups showed excellent symptom and objective control on 24-hour pH metry on short term follow-up.


Keywords: Fundoplication, India, nissen versus toupet


How to cite this article:
Lal P, Leekha N, Chander J, Dewan R, Ramteke VK. A prospective nonrandomized comparison of laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in Indian population using detailed objective and subjective criteria. J Min Access Surg 2012;8:39-44

How to cite this URL:
Lal P, Leekha N, Chander J, Dewan R, Ramteke VK. A prospective nonrandomized comparison of laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in Indian population using detailed objective and subjective criteria. J Min Access Surg [serial online] 2012 [cited 2021 Apr 15];8:39-44. Available from: https://www.journalofmas.com/text.asp?2012/8/2/39/95529



 ¤ Introduction Top


Gastro esophageal reflux disease (GERD) encompasses a disease, which develops when reflux of stomach contents cause troublesome symptoms and its complications. [1] In a developing country like India, diseases like GERD have long been ignored. It is believed that such lifestyle diseases are not as common as in the West, however, such a notion is not only false, but also a hindrance in the justified cure of disease. Though large population based studies are lacking, various small-scale studies from this part of the world have reported the prevalence of GERD to be as high as the western population. [2],[3],[4]

Total (Nissen) fundoplication was first described in 1956 by Rudolf Nissen and has since become widely accepted as a standard treatment for GERD. It is presently being performed laparoscopically at most centres. The Nissen procedure produces excellent symptomatic control, but is associated with significant incidence of postoperative dysphagia rate and side effects such as inability to belch and vomit, and gas bloat syndromeThe study conducted in our own department demonstrated excellent results with Nissen fundoplication and low incidence of transient dysphagia that resolved with time. [5],[6],[7],[8],[9] Multiple techniques with an array of partial wraps have been described in the literature to reduce these unwanted side effects. The most prevalent alternative appears to be the Toupet procedure described in 1963. This is described as a 270-degree posterior fundoplication, with crural closure and fixation of the wrap to the closure. [10],[11] The efficacy of Toupet fundoplication has been demonstrated and a partial wrap is believed to produce less postoperative side effects than the complete wrap. However, some studies have indicated that recurrence rate of reflux symptoms may be higher after Toupet fundoplication. [7,8]

Very few studies have been done in our country evaluating laparoscopic fundoplication in GERD. Patients not responding to proton pump inhibitors (PPIs) are prescribed newer generations of PPIs and their combinations. However, the disease is seldom diagnosed objectively and remains under-treated in most patients. Also, surgery has been a late entrant in the field, because criteria for surgical treatment are more objective and require detailed work up, therefore, protocols for such a study are institutional based and centres doing advanced laparoscopic surgery with facilities for work up are limited in our country. Our initial experiences and another study has reported excellent outcome with LNF. [5],[12] The present study is designed to compare LNF and LTF using diligently performed manometry, 24-hour pH metry and symptomatic analysis, done pre and postoperatively.


 ¤ Materials and Methods Top


The study was conducted between February 2005 and January 2009 in the surgical department of a large tertiary care hospital in New Delhi. A total of 110 patients with symptoms of heartburn, regurgitation and esophagitis on endoscopy even after intensive acid suppression therapy (20-80 mg of omeprazole daily) with proton pump inhibitors for a minimum of 8 weeks were enrolled. All these patients were evaluated for symptoms of GERD using standard questionnaire that included Demeester score (DS) and Modified Visick grade (MVG).

After symptomatic evaluation, these patients underwent esophagogastroduodenoscopy. Esophageal length, grades of esophagitis, Barrett`s esophagus, gastroesophageal junction, hiatus hernia, stomach and duodenum were evaluated in every case. Esophagitis on esophagogastroduodenoscopy was graded by Savary Miller, a new endoscopic grading. [13] Multiple biopsies for histopathology were taken to see esophagitis, dysplasia, Barrett`s esophagus and malignancy of the lower esophagus.

The total length of lower esophageal sphincter (LES) and upper border of LES was determined using MK2 gastrointestinal motility apparatus and Griffon manometry programme (Albyn Medical, UK). A 24-hour pH metry was done using SME Gastrograph Mark-IV pH meter with antimony probe in all patients symptomatic for GERD. Percentage of total time with pH < 4 was calculated using Winreflux programme. GERD on 24-hour pH metry was defined as esophageal pH < 4 for more than 4% of total time with when measured 5 cm above the upper border of LES. Positive pH metry was found in 50 patients. Patients' positive on 24-hour pH metry proceeded for work up for surgical intervention and underwent barium swallow with fluoroscopy to see for shortening of esophagus, presence of hiatus hernia and any reflux of barium in the esophagus and ultrasound abdomen for cholelithiasis . Esophageal manometry was done in these 50 patients at this stage to know total length of LES, length of intraabdominal part of LES, pressure of LES at respiratory inversion point (RIP) and motility of esophageal body. Out of the total 50 patients found fit for surgery and satisfying the criteria for inclusion, the first 25 patients (group A) underwent LNF and the subsequent 25 (group B) underwent LTF.

Operative Technique

A standard technique as described in the literature and as described in detail in the initial paper of this series was used for LNF. [5] However, certain salient points deserve special mention - the hepatic branches of vagus nerve were consciously preserved in the gastrohepatic fold in all the patients. The posterior vagus nerve was identified in every case and taken along with esophagus with the wrap. No bougie was used to size the wrap and short gastric vessels were divided in selective cases only.

In the Toupet procedure, a 270° posterior wrap was created where the wrap was stitched with the lateral aspects of esophagus on left side and on right side with three stitches each. The fundal wrap was also stitched with crurae on each side, thus, creating three rows of interrupted stitches using 2-0 silk. A No 28 FG abdominal drain was placed in the subhepatic space in all the cases through the 12 mm left midclavicular port site.

All patients were evaluated for intraoperative complications including pneumothorax, subcutaneous emphysema, intraabdominal haemorrhage, visceral injury, duration of surgery, intraoperative blood loss, total operating time and conversion to open surgery.

Nasogastric tube was taken out in all the patients on first postoperative day and patients were started on clear liquids. Drain was removed in all cases at 48 hours. All patients were discharged on the 3 rd postoperative period with advice to follow-up on the 7 th day for suture removal and symptom evaluation. Patients were advised to continue soft semi-solid diet for the next 2 weeks.

Statistical Analysis

The Statistical Package for the Social Sciences (SPSS) program for windows was used for statistical analysis. The data was expressed as median, mean and standard deviation. Mean values of DS, MVG, and percent time on 24-hour pH metry, length of LES, intraabdominal length of LES and pressure of LES preoperatively were compared with their respective values postoperatively. The significant difference between non parametric data was calculated by Wilcoxon signed rank test. For parametric data, means were compared using student t test. A paired t-test was used for comparing pre and post operative values in each group.


 ¤ Results Top


Both the group of patients were statistically comparable in terms of sex distribution, age, mean duration of treatment, DS and MVG as shown in [Table 1].
Table 1: Preoperative characteristics of patients in groups A and B.

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Endoscopy was done in all cases; both the groups were statistically similar in terms of endoscopic findings and biopsy. All patients included in study either had grade 2 (39/50) or grade 3 esophagitis. Most patients (90%) had moderate esophagitis on biopsy while the rest of them had severe esophagitis. Barium swallow was done in patients who were positive on 24-hour pH metry, 17 out of a total 25 (68%) in LNF and 16 out of total 25(64%) in LTF had a radiological evidence of reflux.

Manometry done in both the groups revealed a shortened length of LES with a significant reduction in intraabdominal length of LES; there was also decreased pressure at LES at the respiratory inversion point. Number of patients having dysmotility was comparable in both the groups. There was no statistically significant difference in the total time of pH < 4, between the groups [Table 2].
Table 2: Comparison between both groups (pre and post-operative parameters)

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Intraoperative Parameters

Hiatus was repaired with two stitches in 60% of the patients and with three stitches in 40% of the patients. Short gastric vessels were divided in 16% of LNF patients to facilitate a floppy wrap. Posterior vagus nerve was taken along with the wrap in all the patients. Two patients in LNF and one patient in LTF group had serosal tears of the stomach during retraction with Babcock forceps. These serosal tears were repaired with interrupted silk stitches. Intraoperatively, two patients (both in LNF group) had pneumothorax. Chest tube was inserted and removed after 24 hours in both the patients. One patient had subcutaneous emphysema involving abdomen, chest and neck, which resolved after 8 hours.

Mean duration of surgery was compared in both the groups. The mean duration of surgery in LNF was 99 min (range 80 to 140 min), while in LTF it was 115 min (range 90 to 150 min), using t test, a significant difference in the mean duration of surgery was found between the two groups. There was no significant difference found in the amount of blood loss between both the groups. There was no conversion to open surgery in either group.

Post-operative Parameters

In all patients, the nasogastric tube output was less than 25 ml. Requirement of post-operative intramuscular diclofenac sodium for pain relief was comparable in both the groups. Mean subhepatic drain output in LNF group was 28 ml and in LTF, it was 29.5 ml. There was no wound infection or any other complication in any post-operative patient in either group of patients. The mean value of the hospital stay was 3.31 days (range of 3-4 days) in LNF group and 3.17 days (range 3-4 days) in LTF group. All the patients were discharged within 72 hours of surgery.

Patients were followed up in the outpatient clinic at weeks 1, 3 and 6. Five patients in the LNF group developed mild to moderate temporary dysphagia to solids in the post-operative period. Three patients were relieved after a period of 3 weeks, while the other two patients were relieved after a period of 4 weeks post-operatively. One patient developed sensation of epigastric fullness and early satiety after accepting the solid meals post-operatively and was started on tablet Mozapride 5 mg thrice a day. This symptom resolved in four weeks. No patients in the LTF group had any dysphagia to solid. There is a significant difference between the rates of dysphagia, between the two groups. Using chi square test, value of P = 0.036 was found.

At six weeks, all the patients underwent a detailed symptom scoring and evaluation with detailed symptom scoring, manometry and 24-hour pH metry. There was a significant improvement in the symptoms after fundoplication in both the groups. The pre-operative mean length of lower esophageal sphincter was 2.08 cm in both the groups. In the LNF group, it increased to 3.36 cm post-operatively, while in the LTF group, it increased to 3.46 cm postoperatively, an average increase of 1.33 cm in both groups, though the final increase in length was more in LTF as compared to LNF, but the difference was not statistically significant. The mean preoperative intraabdominal length was 0.88 cm that increased significantly to 2.17 cm, an increase of 1.29 cm, thus, both the procedures resulted in a significant increase in intraabdominal length. LES pressure was determined in both the groups pre-operatively and was compared post-operatively at six weeks in both the groups of patients. The mean preoperative LES pressure in LNF group was 7.82 mm of Hg, while it was 5.08 mm of Hg in LTF group; postoperatively it increased to 22 mm of Hg in LNF and 17.75 mm of Hg in LTF, respectively. There was a significant decrease in the acid exposure of the lower esophagus as shown by the 24-hour pH metry. There was no statistically significant difference in the motility in the patients with esophageal dysmotility in either group. No statistically significant difference was found between the groups regarding the outcome, with both the groups showing excellent symptom control and improvement in the manometry and pH metry criteria [Table 2].

The activities of daily living were started after 1-3 days in all the patients in both the groups with mean value of recovery time and return to work of 12.60 days in LNF (range 8-21 days) and 11.50 days (range 9-18 days) in LTF groups. There was no statistical difference in either groups regarding return to work. (P > 0.05)


 ¤ Discussion Top


The age, sex distribution, endoscopic biopsy, grade of esophagitis on endoscopy and duration of symptoms for which patient had taken PPI was comparable in both the groups and is identical to the patient profile reported in other studies. [14],[15],[16] In our study, 85% of the patients in the LNF group had Savary Miller grade 2 esophagitis and 15% of the patients had Savary Miller grade 3 esophagitis, which is similar to the other studies. [17],[18],[19],[20] Reflux of the barium was at least up to the lower one third of the esophagus in 66% of the patients positive for reflux by 24-hour pH metry. This finding has not been well documented in the studies available in the literature. While the presence of reflux on barium swallow correlates well with a positive 24-hour pH metry, its absence does not rule out reflux on pH metry. We also observed that barium swallow is an important investigation to diagnose short esophagus, external anatomy of the esophagus and proximal stomach, incidental peptic esophageal stricture and hiatus hernia.

There was a significant improvement in the symptom score of all patients post-operatively, and the results were comparable to those achieved in a large number of trials. [21],[22],[23],[24] There was no recurrence of symptoms at six weeks of follow-up in either group.

The pre-operative mean length of lower esophageal sphincter, intraabdominal length of LES, LES pressure at respiratory inversion point showed a significant increase post-operatively. The 24-hour pH metry also showed the reflux to be lesser than 4% in all patients. There was no significant statistical difference between the benefits in the two groups. The results obtained were comparable to other studies and showed a remarkable improvement. [14],[18],[19],[24],[25] Successful surgery documents an increase in all three parameters post-operatively and corroborates well with symptomatic improvement. Thus, both the procedures showed an excellent outcome. Randomized trials with both short and long term follow-up periods have showed no differences in antireflux efficacy between Nissen and Toupet fundoplication as in the present study. [20],[21],[26],[27],[28] However, there have been reports of poor symptom control and decreased efficacy of Toupet fundoplication as compared to Nissen, especially on long term follow-up in few studies. [29],[30] All the patients undergoing laparoscopic fundoplication at our centres are being followed up and the comparative data regarding long term follow-up would emerge later.

In our study, two or three stitches were taken to repair hiatus depending on the size of the hiatus. In regard to operating technique, it is similar or comparative to the operative technique described in the literature. [19],[23],[25],[31] However, we did not use a bougie in either group, because we believe that floppiness of the Nissen wrap could be well appreciated laparoscopically and at no point the need of bougie was felt to size the wrap. The study also demonstrates that only a small percentage of patients in the LNF group, the short gastric, were divided, whereas, it was not required in the LTF group. An adequate mobilisation could be achieved without dividing the short gastric. At no place, an attempt was made to compromise mobilisation by not dividing the short gastric vessel. Two recently published studies have also shown that the routine division of short gastric yields neither functional nor clinical advantages in short- or long-term follow-up. [32],[33]

The nasogastric tube was inserted intraoperatively in all the patients (100%) and was removed after 18 hours in all the patients, in our study. In other studies, the nasogastric tube is usually inserted intraoperative with removal at extubation. [34],[35] The sub hepatic drain was placed in all the patients (100%) and was removed after 48 hours in all cases. The drain placement has not been documented in the literature. The routine use of the nasogastric tube and a drain was done as a part of protocol as it was a new study in our institution, though there was no significant drainage in any of the cases. Based on the study, we do not feel any justification for either drain or keeping nasogastric tube after extubation.

The study had a low complication rate. Two patients in the LNF group developed pneumothorax. There was no pneumothorax in the LTF group. There was no case of any major intraabdominal haemorrhage, injury to short gastric vessels, injury to spleen, perforation/injury to esophagus, perforation/injury to stomach, injury to liver, injury to diaphragm, injury to anterior or posterior divisions of the vagus and any other visceral injury. The mean blood loss was less than 20 ml in both the groups. Two patients in the LNF group and one patient in the LTF group had serosal tears of the stomach during retraction with Babcock forceps. This practice was given up and replaced with the use of alternate bowel forceps. Higher incident rates of complication have been mentioned in other studies. [18],[19],[23] The low incidence of complication in our study can be explained by the cautious approach exercised by chief surgeon, with meticulous attention to anatomical details irrespective of the operating time and expertise of the chief surgeon in performing advanced laparoscopic procedures and intracorporeal suturing.

The significant difference in the duration of surgery between the two groups is largely due to the difference in operative technique between the two groups. LTF is technically more demanding as compared to LNF, as it requires more number of intracorporeal knots. The time to start patients on semi solid and solid diet in our study was comparable to the other studies available in the literature. [19],[23],[25]

The mean value of the hospital stay in the LNF group was 3.31 days, as compared to 3.17 days in the LTF group. Other studies have reported a shorter duration of post-operative stay and feasibility of laparoscopic fundoplication being performed as a day care procedure. [36],[37] The longer duration of stay in our study as compared to other studies in the literature is due to the study design.

There is significantly more dysphagia in the LNF group than the LTF group in the early post-operative period. Early post-operative transient dysphagia, that improves with time has been noted in case of Nissen fundoplication in other studies also. [25],[35] Interestingly, high rate of dysphagia (20%) has also been reported in the LTF group. [18] However, some other studies have also reported a similar rate of dysphagia in either group. [21],[26],[38] There have also been reports that the dysphagia in the LNF group may persist on long term and may result in redo surgery. [14],[16],[19],[39] We strongly believe that post-operative dysphagia and patient satisfaction rate may not be entirely dependent on the technique performed and may be improved by careful selection of patients, accurate manometry and 24-hour pH metry and a sound surgical technique. We also believe that post-operative dysphagia may be due to over tightening of the hiatus as already been suggested by other studies also. [40]

To conclude, both LNF and LTF are highly effective in the management of GERD with comparable improvement in symptomatic and objective scoring in the short term. LTF is technically more demanding and takes significantly longer time than LNF. Patients with LNF have an early onset dysphagia that improves with time without any intervention.

 
 ¤ References Top

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2.Rai RR, Sharma M. Prevalence and clinical spectrum of GERD - healthy population. Indian J Gastroenterol 2004;23 Suppl 2:A12.   Back to cited text no. 2
    
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    Tables

  [Table 1], [Table 2]

This article has been cited by
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