Randomized double-blind trial of laparoscopic Nissen fundoplication versus anterior partial fundoplication

BACKGROUND: This double-blind, randomized study compared outcomes of laparoscopic Nissen total fundoplication and anterior partial fundoplication carried out by a single surgeon in a private practice. METHODS: All patients with proven gastro-oesophageal reflux disease, regardless of motility, presenting for laparoscopic antireflux surgery were randomized to either Nissen total or anterior partial fundoplication. Primary outcome measures were dysphagia and abolition of reflux. Secondary outcome measures were Visick scores, bloating, patient satisfaction and reoperation rate. RESULTS: Complete follow-up was available for 161 (98.8 per cent) of 163 patients (84 Nissen, 79 anterior). There were no differences in mean heartburn scores between groups. Recurrent reflux was observed in ten patients after anterior fundoplication, but none after the Nissen procedure. Dysphagia scores for both liquids and solids were lower after anterior fundoplication. Four patients had persistent troublesome dysphagia after Nissen fundoplication compared with none after anterior fundoplication. There were no differences between groups in postoperative bloating. The overall reoperation rate at 2 years was 7 per cent, all achieved laparoscopically. CONCLUSION: Nissen fundoplication cured reflux in all patients up to 2 years, but 5 per cent required revisional surgery. Recurrent reflux was more common after anterior fundoplication, but dysphagia was rare. Patient satisfaction was excellent in both groups. Revisional laparoscopic surgery was safe and usually successful.     

Prospective randomized trial comparing Nissen to Nissen-Rossetti technique for laparoscopic fundoplication

BACKGROUND: It has been suggested that division of the short gastric vessels (SGV) provides a more floppy Nissen fundoplication, for the treatment of reflux disease. The aim of the study was to assess whether Nissen fundoplication with division of SGV is associated with improved clinical outcome and laboratory findings. METHODS:Fifty-six consecutive patients with gastroesophageal reflux disease (GERD) were randomly assigned to have a laparoscopic Nissen fundoplication either with division (24 patients; 15 men; mean age 51 +/- 15 years) or without division (32 patients; 23 men, mean age 47 +/- 14 years) of the SGV. Preoperative and postoperative investigation included clinical assessment, esophagoscopy, esophagogram, esophageal manometry, and 24-hour ambulatory esophageal pH monitoring. RESULTS: Division of the SGV resulted in a significant increase of the operating time (P <0.0001). The operation abolished reflux in both groups. Also, both types of Nissen fundoplication significantly increased the amplitude of peristalsis at distal esophagus (division group: from 56 +/- 20 mm Hg to 64 +/- 25 mm Hg, P = 0.01; nondivision group: from 65 +/- 27 mm Hg to 75 +/- 26 mm Hg, P <0.001) and the lower esophageal sphincter pressure (division group: from 16 +/- 10 mm Hg to 24 +/- 7 mm Hg, P <0.001; nondivision group: from 22 +/- 8 mm Hg to 28 +/- 5 mm Hg, P <0.001). No differences in the incidence of postoperative severe dysphagia (division group: 5 of 24; nondivision group: 3 of 32) and overall esophageal transit were accounted between groups. However, division of the SGV was associated with a significant increased incidence of gas-bloating syndrome (division group, 13 of 24, versus nondivision group, 9 of 32, P = 0.02). CONCLUSIONS: Division of the SGV at laparoscopic Nissen fundoplication for GERD does not improve clinical outcome and laboratory findings, while it is associated with prolongation of the operating time and increased incidence of gas-bloating syndrome.     

Prospective double-blind randomized trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels.

OBJECTIVE: To determine whether division of the short gastric vessels (SGVs) and full mobilization of the gastric fundus is necessary to reduce the incidence of postoperative dysphagia and other adverse sequelae of laparoscopic Nissen fundoplication. SUMMARY BACKGROUND DATA: Based on historical and uncontrolled studies, division of the SGVs has been advocated during laparoscopic Nissen fundoplication to improve postoperative clinical outcomes. However, this modification has not been evaluated in a large prospective randomized trial. METHODS: One hundred two patients with proven gastroesophageal reflux disease presenting for laparoscopic Nissen fundoplication were prospectively randomized to undergo fundoplication with (52 patients) or without (50 patients) division of the SGVs. Patients with esophageal motility disorders, patients requiring a concurrent abdominal procedure, and patients who had undergone previous antireflux surgery were excluded. Patients were blinded to the postoperative status of their SGVs. Clinical assessment was performed by a blinded independent investigator who used multiple standardized clinical grading systems to assess dysphagia, heartburn, and patient satisfaction 1, 3, and 6 months after surgery. Objective measurement of lower esophageal sphincter pressure, esophageal emptying time, and distal esophageal acid exposure and radiologic assessment of postoperative anatomy were also performed. RESULTS: Operating time was increased by 40 minutes (median 65 vs. 105) by vessel division. Perioperative outcomes and complications, postoperative dysphagia, relief of heartburn, and overall satisfaction were not improved by dividing the SGVs. Lower esophageal sphincter pressure, acid exposure, and esophageal emptying times were similar for the two groups. CONCLUSION: Division of the SGVs during laparoscopic Nissen fundoplication did not improve any clinical or objective postoperative outcome.     

Single center prospective randomized trial of laparoscopic Nissen versus anterior 90° fundoplication

Although Nissen fundoplication is a very effective treatment for gastroesophageal reflux, it is associated with a small incidence of troublesome postoperative side effects. To prevent this, progressive modification of surgical techniques has led to the development of an anterior 90° fundoplication. We undertook a prospective randomized trial to compare this procedure with Nissen fundoplication to determine whether it would achieve a better clinical outcome. Patients presenting to a single center for primary laparoscopic antireflux surgery were randomized to undergo either an anterior 90° fundoplication (n=40) or a Nissen fundoplication without division of the short gastric vessels (n=39). Clinical questionnaires were used to assess outcome at 1 month, 3–6 months, and 12 months. Both patients and the clinical interviewer were masked as to which procedure was performed. Follow-up with endoscopy, esophageal manometry, and pH monitoring was also undertaken. Operating time was similar for the two procedures (60 minutes for anterior vs. 55 minutes for Nissen fundoplication). Early postoperative complications were more common after Nissen fundoplication (18% vs. 5%). Two patients underwent laparoscopic reoperation for recurrent reflux after anterior 90° fundoplication, and four underwent laparoscopic reoperation after Nissen fundoplication (dysphagia, 3 patients; acute hiatus hernia, 1 patient). One year after surgery, dysphagia and other wind-related side effects were less common after anterior 90° fundoplication. Control of reflux symptoms and satisfaction with the overall outcome was similar for the two procedures. Anterior 90° fundoplication is followed by fewer side effects than Nissen fundoplication. This advantage is offset by a greater likelihood of reflux recurrence. However, this does not diminish patient satisfaction. Financial support for this study was provided from a project grant (no. 157986) from the National Heath and Medical Research Council of Australia (to D.I.W. and G.G.J.).     

Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication

HYPOTHESIS: Laparoscopic anterior 90 degrees partial fundoplication for gastroesophageal reflux is associated with a lower incidence of postoperative dysphagia and other adverse effects compared with laparoscopic Nissen fundoplication. DESIGN: A multicenter, prospective, double-blind, randomized controlled trial. SETTING: Nine university teaching hospitals in 6 major cities in Australia and New Zealand. PARTICIPANTS: One hundred twelve patients with proven gastroesophageal reflux disease presenting for laparoscopic fundoplication were randomized to undergo either a Nissen (52 patients) or an anterior 90 degrees partial procedure (60 patients). Patients with esophageal motility disorders, patients requiring a concurrent abdominal procedure, and patients who had undergone previous antireflux surgery were excluded from this study. INTERVENTIONS: Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication. MAIN OUTCOME MEASURES: Independent assessment of dysphagia, heartburn, and overall satisfaction 1, 3, and 6 months after surgery using multiple clinical grading systems. Objective measurement of esophageal manometric parameters, esophageal acid exposure, and endoscopic assessment. RESULTS: Postoperative dysphagia, and wind-related adverse effects were less common after a laparoscopic anterior 90 degrees partial fundoplication. Relief of heartburn was better following laparoscopic Nissen fundoplication. Overall satisfaction was better after anterior 90 degrees partial fundoplication. Lower esophageal sphincter pressure, acid exposure, and endoscopy findings were similar for both procedures. CONCLUSIONS: At the 6-month follow-up, laparoscopic anterior 90 degrees culine partial fundoplication is followed by fewer adverse effects than laparoscopic Nissen fundoplication with full fundal mobilization, and it achieves a higher rate of satisfaction with the overall outcome. However, this is offset to some extent by a greater likelihood of recurrent gastroesophageal reflux symptoms.     

Ten-year clinical outcome of a prospective randomized clinical trial of laparoscopic Nissen versus anterior 180( degrees ) partial fundoplication

Background:

A randomized trial of laparoscopic Nissen fundoplication and anterior 180° partial fundoplication was undertaken to determine whether the anterior procedure might reduce the incidence of dysphagia and other adverse outcomes following surgery for gastro‐oesophageal reflux disease. This study evaluated clinical outcomes after 10 years.

Methods:

Some 107 patients were randomized to undergo laparoscopic Nissen or anterior 180° partial fundoplication. Ten‐year data were not available for 18 patients. Information was obtained from 89 patients (48 Nissen, 41 anterior fundoplication) using a standard clinical questionnaire that focused on symptoms of reflux, potential postoperative side‐effects and overall satisfaction with the outcome of surgery.

Results:

There were no significant differences between the two groups with regard to reflux symptoms, dysphagia, abdominal bloating, ability to belch and overall satisfaction. Between 5 and 10 years after surgery, revisional surgery was required for reflux in two patients after anterior fundoplication. Two patients had revision after Nissen fundoplication, for reflux and recurrent hiatus hernia.

Conclusion:

Both laparoscopic anterior 180° partial and Nissen fundoplication are safe, effective and durable at 10 years' follow‐up. Most patients are satisfied with the clinical outcome. Copyright © 2008 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.     

A prospective randomized trial of laparoscopic Nissen fundoplication with anterior vs posterior hiatal repair.

HYPOTHESIS: The technique used for repair of the esophageal hiatus during laparoscopic Nissen fundoplication can influence the likelihood of postoperative dysphagia. DESIGN: A prospective double-blind randomized control trial. SETTING: A university teaching hospital. PARTICIPANTS: A total of 102 patients with proven gastroesophageal reflux disease, undergoing a laparoscopic Nissen fundoplication were randomized to undergo fundoplication with either anterior (47 patients) or posterior (55 patients) repair of the diaphragmatic hiatus. Patients were excluded for the following reasons: they had esophageal motility disorders, required a concurrent abdominal procedure, had undergone previous antireflux surgery, or had very large hiatus hernias. INTERVENTIONS: Laparoscopic Nissen fundoplication with anterior vs posterior hiatal repair. MAIN OUTCOME MEASURES: Independent assessment of dysphagia, heartburn, patient satisfaction, and other symptoms 1, 3, and 6 months following surgery, using multiple standardized clinical grading systems. Objective measurement of lower esophageal sphincter pressure, esophageal emptying time, distal esophageal acid exposure, and endoscopic assessment of postoperative anatomy and esophageal mucosa. RESULTS: Symptoms of postoperative dysphagia, relief of heartburn, and overall satisfaction 6 months after surgery were not influenced by the hiatal repair technique. However, to achieve a similar incidence of dysphagia, more patients who initially underwent posterior hiatal repair required a second surgical procedure (6 vs 0 patients). The hiatal repair technique did not affect the likelihood of early postoperative paraesophageal herniation. CONCLUSION: Anterior suturing of the hiatus appears to be at least as good in the short-term as posterior suturing as a method of narrowing the hiatus during laparoscopic Nissen fundoplication.     

Day-case laparoscopic Nissen fundoplication

Introduction   Nissen fundoplication has been performed laparoscopically for over 15 years, being associated with shorter hospital stay and fewer complications than conventional open surgery with good long-term outcomes. Day-case laparoscopic Nissen fundoplication (LNF) is rarely performed in the UK and most series in the literature report length of stay >2 days. Methods   The objective of this study was to examine the safety and efficacy of day-case LNF. The clinical records of all patients undergoing LNF under the care of three surgeons in a district general hospital (DGH) during a 5-year period (January 2003 to December 2007) were reviewed to examine length of stay, complications, length of procedure, grade of operating surgeon and symptoms on follow-up. Results   One hundred thirteen day-case LNFs were recorded in this series. Day-case LNF patients had median age of 45 years (range 20–68 years, 65% (64.6%) male) and 98% were American Society of Anesthesiologists (ASA) grade I or II. Twenty-one cases (19%) were performed by higher surgical trainees. Median operative time was 54 minnutes (range 25–120 min). Only one perioperative complication (port-site bleed) occurred, treated without prolonging length of stay. The proportion of all LNF performed as day cases increased from 8% to 52% during the study period. Median operative time has significantly reduced from the first 20 consecutive LNF cases to the latest 20 cases [65 min (range 40–120 min) versus 48 min (range 25–72 min); p = 0.037]. At follow-up (median 7 weeks, range 2–31 weeks) 82% of patients had improvement in all presenting symptoms. Eight patients had postoperative complications [wound infection (n = 2), persistent regurgitation requiring laparoscopic division of a gastric band adhesion (n = 1), dysphagia (n = 5 with two patients requiring redo partial fundoplication and one patient requiring dilatation) and there were no conversions to open surgery. Conclusion   Day-case LNF is safe and effective for treating selected patients with gastroesophageal reflux disease (GERD) in a DGH. The proportion of day-case LNFs is increasing in our unit. Half of the LNFs in a DGH can be done as day cases. Experience is associated with a significant reduction in operative time.     

Day-case laparoscopic Nissen fundoplication

Introduction:

For day-case laparoscopic surgery to be successful, patient selection is of the utmost importance. This study aimed to assess the feasibility of day-case laparoscopic Nissen fundoplication and to identify factors that may lead to readmission and overstay.

Methods:

A retrospective review of all patients who underwent day-case laparoscopic Nissen fundoplication over a 4-year period (2006 through 2010) was undertaken. Patient age, social circumstances, and other demographics were recorded as well as any comorbidities and ASA score. The primary endpoint measured was rate of readmission and overstay.

Results:

A total of 72 patients fulfilled the inclusion criteria for day-case surgery. Five patients (6.94%) required admission immediately following the procedure, ie, overstayed or were readmitted. The rates were 1.38% (P=.05, CI 95%) for readmission and 5.55% (P=.05, CI 95%) for overstay. Six (8.33%) patients were classified as ASA III, and 3 (50%) were readmitted or overstayed.

Conclusion:

Day-case laparoscopic Nissen fundoplication is a feasible, safe option. The authors conclude that ASA score of III and increasing age correlate with an increasing incidence of overstay and readmission. Therefore, we would recommend the use of integrated pathways and advanced planning to reduce these rates.     

Day-case laparoscopic Nissen fundoplication

BACKGROUND: The aim was to assess the acceptability and safety of day-case laparoscopic fundoplication for gastro-oesophageal reflux disease (GORD). METHODS: This prospective study commenced in December 1999 and lasted for 18 months. All patients had proven symptomatic GORD. Inclusion criteria were American Society of Anesthesiologists grade I or II with adequate home support. A standard anaesthetic, analgesic and antiemetic protocol was used. Patients were contacted by telephone on the night of discharge and arrangements were made for a nurse to visit the following day. Postoperative pain and nausea were assessed using visual analogue scores (scale 0-10) on a self-completion questionnaire. RESULTS: Twenty patients were included. There were no postoperative complications. All patients were discharged on the day of surgery. Median time to discharge was 6 h 30 min (range 4.5 to 9 h). One patient reattended casualty the following morning but none required readmission. There was no significant difference in median pain or nausea scores the evening after surgery or the next morning. All patients were satisfied with the information given and aftercare provided. All would recommend it to a friend and 19 of 20 would undergo the procedure as a day case again. CONCLUSION: This study suggests that day-case laparoscopic fundoplication is feasible. Patients find it acceptable and it appears safe.     

Five-year subjective and objective results of laparoscopic and conventional Nissen fundoplication: a randomized trial

OBJECTIVE: The purpose of this prospective study was to compare the subjective and objective outcome of laparoscopic (LNF) and conventional Nissen fundoplication (CNF) up to 5 years after surgery as obtained in a multicenter randomized controlled trial. SUMMARY OF BACKGROUND DATA: LNF is regarded as surgical treatment of first choice for refractory gastroesophageal reflux disease by many surgeons based on several short- and mid-term studies. The long-term efficacy of Nissen fundoplication, however, is still questioned as objective data gathered from prospective studies are lacking. METHODS: From 1997 to 1999, 177 patients were randomized to undergo LNF or CNF. Five years after surgery, all patients were requested to fill in questionnaires and to undergo esophageal manometry and 24-hour pH-metry. RESULTS: A total of 148 patients agreed to participate in the follow-up study: 79 patients after LNF and 69 after CNF. Of these, 97 patients (48 LNF, 49 CNF) consented to undergo esophageal manometry and 24-hour pH-metry. At 5 years follow-up, 20 patients had undergone reoperation: 12 after LNF (15%) and 8 after CNF (12%). There was no difference in subjective outcome, with overall satisfaction rates of 88% and 90%, respectively. Total esophageal acid exposure times (pH < 4) were 2.1% +/- 0.5% and 2.0% +/- 0.6%, respectively (P = 0.21). Antisecretory medication was taken daily in 14% and 16%, respectively (P = 0.29). There was no correlation between medication use and acid exposure and indices of symptom-reflux association (symptom index and symptom association probability). No significant differences between subjective and objective results at 3 to 6 months and results obtained at 5 years after surgery were found. CONCLUSIONS: The effects of LNF and CNF on general state of health and objective reflux control are sustained up to 5 years after surgery and the long-term results of LNF and CNF are comparable. A substantial minority of patients in both groups had a second antireflux operation or took antisecretory drugs, although the use of those medications did not appear to be related to abnormal esophageal acid exposure.     

Inflammatory response in children after laparoscopic vs open Nissen fundoplication: randomized controlled trial

We performed a randomized controlled trial to compare the inflammatory and immune responses to Nissen fundoplication in infants and children undergoing either open or laparoscopic surgery.

Methods

Forty children undergoing Nissen fundoplication were randomized to laparoscopy or open surgery using minimization with respect to age, neurologic status, and operating surgeon. Intraoperative and postoperative analgesias were standardized. Inflammatory markers (plasma malondialdehyde, nitrate plus nitrite level, and cytokines) and monocyte class II major histocompatibility complex expression were measured preoperatively, at end of surgery, 4, 24, and 48 hours postoperatively. Postoperative changes were compared between open and laparoscopic groups.

Results

There were no significant changes in circulating malondialdehyde, nitrates plus/ nitrite, interleukin-10, or tumor necrosis factor α in the postoperative period in either group. Interleukin-1 receptor antagonist (IL-1rA) and IL-6 were significantly increased in both groups, with a tendency for greater elevation of IL-1rA in the open group. Monocyte major histocompatibility complex expression fell significantly in both groups; however, this fall appeared to be slightly more marked in the open group.

Conclusions

The postoperative cytokine response is similar in children undergoing open and laparoscopic Nissen fundoplication. This trial indicates that laparoscopy may partly reduce postoperative immune suppression.     

Prospective, randomized trial of bipolar electrosurgery vs ultrasonic coagulation for division of short gastric vessels during laparoscopic Nissen fundoplication

BACKGROUND: Division of the short gastric vessels (SGV) during laparoscopic Nissen fundoplication (LNF) may improve outcome. Several techniques are available for SGV division. The aim of this study was to compare in a prospective randomized trial bipolar electrocautery with cutting blade versus ultrasonic coagulation of the SGV during LNF. METHODS: In all, 86 consecutive patients undergoing LNF were prospectively randomized into two similar groups that underwent division of the SGV, respectively, using bipolar cutting forceps (BPCF) or harmonic coagulating shears (HCS). Operative time, bleeding episodes, complications, equipment problems, and surgeon's subjective scoring of satisfaction and ease of use were assessed. RESULTS: Mean (+/-SD) time for fundic mobilization and division of the SGV was not significantly different between the two groups (BPCF = 20 +/- 12 min vs. HCS = 22 +/- 12 min). Bleeding events, estimated blood loss, surgeon satisfaction, and subjective ease of use were similar, and no transfusions were required. Complications in the BPCF group included a delayed gastric perforation requiring reoperation and two gastric serosal burns repaired intraoperatively. There was one splenic capsular tear using the HCS and one splenic capsular tear using the BPCF, both of which were controlled intraoperatively. The number of functional equipment problems were few and statistically similar. In the authors' institution, the per case total costs with capital expenditures amortized over 100 cases indicate savings of approximately $202/case with use of the BPCF versus the HCS. Regression analysis demonstrated a significant correlation between body mass index (BMI) and total case length and time for division of the SGVs. CONCLUSIONS: The BPCF and HCS appear to be equally efficacious for SGV division during LNF. Judicious application of both energy forms and heightened vigilance for gastric serosal injury are required with use of both the BPCF and HCS in cases of tight gastrosplenic adhesions or short SGVs. The BPCF carries a potential cost advantage over the HCS in the authors' institution. The BMI directly correlates with time required to divide SGVs and total length of LNF.     

Randomized clinical trial of robot-assisted versus laparoscopic Nissen fundoplication

BACKGROUND: Several studies have shown the safety and feasibility of robot-assisted antireflux surgery but comparative data are lacking. METHODS: Fifty consecutive patients scheduled for laparoscopic antireflux surgery were randomized into two groups. Twenty-five patients underwent robot-assisted surgery and 25 standard laparoscopic fundoplication. All robot-assisted procedures were performed with the da Vinci Surgical System. RESULTS: There were no significant differences in age, sex, body mass or preoperative reflux pattern between the groups. Operating times were significantly longer for robot-assisted than standard laparoscopic operations (mean total operating time 131.3 versus 91.1 min, P < 0.001; skin-to-skin time 78.0 versus 63.5 min, P = 0.001). There was no conversion to open surgery. Conversion to standard laparoscopy was necessary in one of 25 robot-assisted procedures. The length of hospital stay was similar in both groups. Robot-assisted surgery was associated with significantly higher mean total costs (euro 3157 versus euro 1527; P < 0.001). There were no significant differences in clinical, endoscopic and functional outcomes between groups. There was no procedure-related mortality. CONCLUSION: Robot-assisted laparoscopic fundoplication is comparable to the standard laparoscopic procedure in terms of feasibility and outcome, but costs are higher owing to longer operating times and the use of more expensive instruments.