Surg Endosc DOI 10.1007/s00464-014-4017-5
and Other Interventional Techniques
Residual fundus or neofundus after laparoscopic sleeve gastrectomy: is fundectomy safe and effective as revision surgery? Gianfranco Silecchia • Francesco De Angelis • Mario Rizzello • Alice Albanese • Fabio Longo Mirto Foletto
•
Received: 26 July 2014 / Accepted: 19 November 2014 Ó Springer Science+Business Media New York 2014
Abstract Introduction Up to 30 % of patients who have undergone laparoscopic sleeve gastrectomy require revision surgery for inadequate weight loss, weight regain, and/or the development of severe upper gastrointestinal symptoms. The aim of this retrospective study was to evaluate the safety and efficacy of laparoscopic fundectomy (LF) in cases of a residual fundus/neofundus development regarding GERD symptoms. Methods The study group comprised 19 patients (17 female; mean BMI 35.4 kg/m2) divided into 2 groups. Group A (n = 10) patients with severe GERD and evidence of residual fundus/neofundus, Hiatal hernia with good results in terms of weight loss. Group B (n = 9) patients with severe GERD, a residual fundus/neofundus, inadequate weight loss or weight regain. Fundectomy was indicated when a residual fundus/neofundus was associated with severe GERD symptoms. The presence of a residual fundus/neofundus was assessed by a barium swallow and/ or multislice computed tomography. Results No mortality or intra-operative complications occurred. Five postoperative complications occurred: 2 cases of bleeding, 1 mid-gastric stenosis and 2 leaks
G. Silecchia F. De Angelis (&) M. Rizzello F. Longo Division of General Surgery & Bariatric Center of Excellence, Department of Medico-Surgical Sciences and Biotechnology, Hospital ICOT, Sapienza University of Rome, Via F. Faggiana 1668, 04100 Latina, Italy e-mail: [email protected] G. Silecchia e-mail: [email protected] A. Albanese M. Foletto IFSO Bariatric Center of Excellence, Policlinico Universitario, University of Padova, Via Giustiniani 2, 35128 Padua, Italy
(10.5 %). All patients experienced improvements in their GERD symptoms and stopped PPI treatment. Group B exhibited an additional %EWL of 53.4 % at 24 months. Conclusion LF and cruroplasty is feasible and has good results in terms of GERD symptoms control and additional weight loss. The high rate of postoperative complications observed in this series remains a matter of concern. A resleeve procedure might be considered as an alternative to RYGB/DS conversion restricted to selected patients. Keywords Fundectomy GERD Hiatal hernia Obesity Revised sleeve gastrectomy
Introduction Laparoscopic sleeve gastrectomy (LSG) has become a very popular bariatric procedure. Although it was originally conceived as a bridging surgery for superobese patients, low complication rates and good 3- to 5-year results in terms of weight loss and resolution of co-morbidities have strengthened the role of LSG as a definitive procedure [1–3]. However, up to 30 % of patients who have undergone LSG require revision surgery for inadequate weight loss, weight regain, or the development of severe upper gastrointestinal (GI) symptoms [mainly gastro-esophageal reflux disease (GERD)] [1, 4]. Weight regain or insufficient weight loss can be successfully managed with conversion to laparoscopic gastric bypass (LRYGB) or duodenal switch (DS), both of which also help to relieve the symptoms of GERD [4]. The appearance or worsening of GERD symptoms after LSG is reported in 20–30 % of cases [1, 4, 5]. Many mechanisms may be involved, including a missed hiatal hernia (HH) during LSG, which can result in postoperative
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transhiatal migration of the upper portion of the sleeve; incomplete gastric fundus resection (residual fundus); neofundus development; or ‘‘de novo’’ GERD due to an incompetent lower esophageal sphincter. The first-line treatment comprising high-dose proton pump inhibitors (PPI) fails in most cases [5]. When GERD symptoms significantly impair patients’ quality of life, regardless of whether the symptoms are combined with insufficient weight loss or weight regain, revision surgery is indicated. Although conversion to LRYGB seems to be the preferred revision approach, resection of the residual fundus or neofundus (fundectomy as the main part of a resleeve) with hiatal defect repair (if present) might be an alternative strategy in some patients [1, 6]. The aim of this retrospective study was to evaluate the safety and efficacy of laparoscopic fundectomy in cases of a residual fundus or neofundus development regarding severe upper GI symptoms.
eating or behavioral disorders. Compliance with the LSG eating pattern was considered to be a selection criterion for fundectomy. The presence of a residual fundus or development of a neofundus was assessed in all patients by a barium swallow after comparison with previous upper GI series performed 30 days after the primary sleeve gastrectomy. (Reviewer 1, third Question) (Fig. 1). Multislice computed tomography (CT) with 3-dimensional reconstruction was performed in 9 patients (Fig. 2). Each scan was performed with a 64-row
Methods We retrospectively analyzed the prospectively collected databases of 2 Bariatric Centers of Excellence. The study group comprised 19 patients (17 female; mean body mass index [BMI], 36.5 kg/m2) who underwent laparoscopic fundectomy with or without crura repair for concomitant HH. The study was approved by the ethic committees of the two hospitals involved. (1 Reviewer, first question). The patients were divided into 2 groups. Group A (n = 10) comprised patients with severe GERD and evidence of a residual fundus, neofundus development, HH, and/or transhiatal migration of the upper portion of the sleeve but with good results in terms of weight loss (percent excess weight loss [%EWL], [50 %). Group B (n = 9) comprised patients with severe GERD, a residual fundus, neofundus development, inadequate weight loss, or weight regain (median %EWL before revision, 19 %) with a mean BMI at the nadir after the primary procedure of 38.3 (36–42.7). (1 Reviewer, fourth question). Laparoscopic re-sleeve (fundectomy) was indicated when a residual fundus or neofundus was associated with severe GERD symptoms that did not respond to a high doses of PPI (Omeprazole 80 mg/BID for 8 weeks) (1 Reviewer, Second question). All patients either had contraindications to or refused to undergo conversion to bypass procedures (RYGB or DS). Fundectomy was not offered to patients when upper GI endoscopy demonstrated severe esophagitis (higher than Los Angeles grade B) (1 Reviewer, Fifth question). or nutritional or psychological contraindications to further restrictive surgery. All patients were referred to a nutritionist and psychologist for the assessment of their eating habits and to undergo screening in search of any
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Fig. 1 Barium swallow shows residual fundus and migrated sleeve with hiatal hernia
Fig. 2 CT scan shows transhiatal migration of the upper portion of the sleeve with neofundus development
Surg Endosc
multidetector CT scanner in the craniocaudal direction immediately after oral administration of 500 ml of a 4 % solution of iodinated contrast medium and tap water. As previously reported, tridimensional reconstruction was manually performed for the quantification of the sleeve and antrum volumes [7]. Fundectomy was performed in patients with a residual fundus or neofundus development associated with a residual gastric volume [250 ml in agreement with the criteria proposed by Noel [8, 9]. Upper GI symptoms were assessed by a validated questionnaire (Rome III criteria) [5, 10] followed by upper GI endoscopy (1 Reviewer, Fifth question) to rule out mucosal lesions and Helicobacter pylori infection. One month after the surgical procedure, a barium swallow upper GI series was performed in all patients to evaluate the HH repair and/or neofundus excision. The persistence of GERD symptoms was investigated at a minimum follow-up of 24 months using the same validated questionnaire administrated preoperatively.
Surgical technique The fundectomy begun with careful adhesiolysis at the level of the left gastric tube border, taking care to completely dissect the neofundus, and thus obtain complete exposure of the left crus. In patients with a hiatus defect associated with sleeve migration, a complete reduction into the abdomen of the migrated sleeve and at least 4 cm of the distal esophagus was achieved. The fundectomy, calibrated on a 36- to 42-Fr orogastric bougie, was performed with sequential green cartridges (Ethicon Endo-Surgery Inc., Cincinnati, OH, USA) reinforced in 9 patients with bioabsorbable strips (Seamguard tissue reinforcement, W. L. Gore & Associates, 101 Inc., Flagstaff, AZ, USA) and in the remaining 10 patients with fibrin glue (Tisseel, 4 ml; Baxter International Deerfeld, IL, USA). The last shot was fired at least 1.5 cm distal to the esopha-gogastric junction. An intra-operative methylene blue test was routinely performed to check for gastric leakage, and a drain was routinely left in place for 24 h. The hiatal defect was repaired with 2 or 3 non-absorbable stitches approximating the pillars. Large defects ([4 cm2) were reinforced with a synthetic absorbable mesh (BIO A tissue reinforcement, W. L. Gore & Associates, 101 Inc., Flagstaff, AZ, USA) anchored with absorbable tacks and/or fibrin glue [11]. The cruroplasty was calibrated on a 32-Fr bougie.
Results In 8 patients (42.1 %), the LSG was performed as a revision procedure after band failure. According to the Rome
III questionnaire, 13 patients (68.4 %) had symptoms with a score of 3 (daily GERD symptoms), and 6 patients (31.6 %) had symptoms with a score of 2 (GERD symptoms at least 3 times a week). Six patients (31.6 %) were superobese (BMI, 55.2 kg/m2) before primary LSG. The mean time interval between LSG and fundectomy was of 38.7 months (range 12–80 months). The mean BMI before the primary LSG was of 44 (35–55). At the time of fundectomy, the mean BMI was 36.5 (32–52) kg/m2. The mortality rate was of 0 %. In 10 patients, a concomitant cruroplasty was carried out; in 5 patients with a hiatal defect of [4 cm2, the cruroplasty was reinforced with a synthetic absorbable mesh (Gore BIO-A). In all patients, the staple line was reinforced (Seamguard or Tisseel). No intra-operative complications occurred. Five (26.3 %) postoperative complications occurred: 2 cases of staple line bleeding that required blood transfusions, 1 mid-gastric stenosis successfully treated with 3 sequential endoscopic dilations, and 2 leaks in the upper portion of the fundectomy. Both fistulas were treated conservatively with percutaneous drains, enteral feeding, and endoscopic placement of a covered stent (recovery time, 35 and 45 days, respectively). Unfortunately, one of the later patients developed a recurrent esophago-pleural fistula that, after 6 months of unsuccessful conservative treatment, required surgical revision (total gastrectomy with esophago-jejunal anastomosis). Seventeen patients completed a minimum follow-up period of 24 months. After the re-sleeve, all patients had an upper GI series (gastrographinÒ) in the first p.o. day, and then a barium swallow one month after surgery and every 12 months. The comparison of the X-ray series did not show any evidence of a residual fundus nor HH recurrence in Group A patients. (1 Reviewer, question 6). All patients experienced improvements in their upper GI symptoms as assessed by the Rome III questionnaire and stopped PPI treatment within 3 months. Group B exhibited an additional %EWL of 53.4 % at 24 months. The mean BMI 24 months after fundectomy was of 28.8 (23–41.9)
Discussion LSG has been widely accepted as a stand-alone procedure because of its good outcomes in terms of weight loss, low complication rates, and resolution of comorbidities, similar to RYGB [1–3]. However, about 10 % of LSG procedures are followed by insufficient weight loss or weight regain, and up to 40 % of patients complain of upper GI symptoms that significantly impair their quality of life and decrease patient satisfaction [5]. Weiner et al. recognized two mechanisms of weight regain: loss of restriction and/or
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changes in eating behavior [4]. Himpens et al. reported significant weight regain between the third and sixth postoperative years associated with symptomatic GERD that occurred with an incidence of up to 22 % after 1 year [1]. The occurrence or persistence of GERD remains a controversial issue. In their systematic review, Chiu et al. reported that most studies did not find an increase in the occurrence of symptomatic GERD after LSG [12]. Tai et al. reported that postoperative GERD and esophagitis were related to the presence of HH [13]. Petersen et al. postulated that LSG plays a role in the increased lower esophageal pressure regardless of weight loss after LSG and may protect patients from postoperative GERD [14]. Himpens’s group demonstrated a biphasic pattern after LSG. The first peak of GERD developed during the first year after surgery, and the second peak of GERD developed later and was associated with neofundus appearance [1]. The development of a neofundus or the presence of a residual fundus might be involved in weight regain and postoperative GERD. The undissected residual fundus or the development of a neofundus with a concomitant hiatal defect is considered to be a risk factor for symptomatic reflux, and fundectomy with concurrent cruroplasty has been advocated as a valid treatment option [15]. The revised LSG (rLSG) is a relatively new option, and data on its outcomes are very limited. The rationale of this technique is to resize the sleeve when dilation appears on an upper GI series or CT scan volumetry scan. Evaluation by a radiologist is crucial for accurate assessment of the volume and shape of the fundus and concomitant intrathoracic migration. Based on radiological studies by Braghetto, a threshold of 250 cm3 has been proposed as the indication for eventual fundectomy [17]. The rLSG reduces acid production and restricts additional weight loss. Multidisciplinary assessment is mandatory in patients with severe GERD (gastroenterologist consultation, endoscopy, and pH manometry if indicated) and insufficient weight loss or long-term weight regain to rule out concomitant contributive factors (binge eating disorders, sweet eating, or detrimental eating patterns). The indications for and technique of fundectomy after rLSG are still debated, and no long-term data are available. The first rLSG was reported by Gagner and Rogula and showed good results in terms of complications and efficacy (additional EWL) [16]. Dapri et al. observed a leakage rate of 14.2 % in a series of 7 patients (Table 1) [19]. Rebibo et al. reported a series of 15 patients with a %EWL of 66 % at the 12-month follow-up, a complication rate of 20.0 % including 2 gastric fistulas (13.0 %), and a mortality rate of 6.6 % [17]. Noel et al. presented the largest series of patients undergoing rLSG (n = 36) without complications or mortality and with a mean %EWL of 53.4 % at a mean follow-up of 14.5 months [9]. The main advantages
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Table 1 Re-sleeve gastrectomy complication rate Authors
Year
N. Pts
Dapri et al. [19]
2010
7
Complication rate (Overall)
Leak
14.20 %
14.20 %
Iannelli et al. [20]
2010
13
Rebibo et al. [17]
2012
15
0
Noel et al. [9]
2013
36
2.70 %
Current study
2014
19
26.30 %
20.00 %
0 13.30 % 0 10.50 %
advocated for rLSG over bypass procedures are no risks of anemia, vitamin deficiency, or osteopenia; a decrease in acid production and ghrelin; and preservation of the pylorus. The purpose of this retrospective study was to evaluate the safety and efficacy of fundectomy regarding GERD symptom control and/or additional EWL when insufficient weight loss or weight regain was present in a selected group of patients. This is the first study to assess the effect of fundectomy in a subgroup of patients with good %EWL and comorbidity control but with severe and persistent upper GI symptoms unresponsive to medical treatment (Group A). The recent systematic review of the ASMBS Revision Task Force, suggest the conversion to LRYGB in case of severe GERD post-LSG refractory to PPI treatment as effective option [6] (Reviewer 2 comment). In our series, the patients in Group A did not show severe esophagitis on upper GI endoscopy. Six patients refused conversion to a bypass procedure, and such procedures were contraindicated in 4 patients because of post-thyroidectomy/ parathyroidectomy osteopenia or hypocalcemia requiring chronic calcium and vitamin D supplementation. Our 26 % rate of postoperative complications is similar to that in previous studies [17, 19]. The results of the present study confirm that revision bariatric surgery has a higher complication rate [18]. The incidence of leakage in the present series was of 10.5 % (Table 1). Resolution of GERD symptoms was observed in 16 patients (9 in Group A and 7 in Group B) at the 24-month follow-up with an additional %EWL of 53.4 % (Group B). This study has several limitations, including its retrospective nature, limited number of patients, short follow-up period, lack of fundus volume evaluation by CT scan volumetry in all patients, lack of routine postoperative upper GI endoscopy, and lack of pH manometry to assess GERD. However, this is the first report of LSG by laparoscopic fundectomy as a revision surgery mainly for severe upper GI symptoms and weight loss failure with a 24-month follow-up period. GERD symptoms were assessed in all patients with a validated questionnaire, and upper GI endoscopy was used to evaluate the presence of
Surg Endosc
esophagitis, which represented the main indication/contraindication for fundectomy. The results of the present study suggest that fundectomy effectively controls upper GI symptoms in 90 % of patients at 24 months postoperatively. An additional %EWL was achieved in all patients with insufficient loss or weight regain. This option can be offered to selected patients with contraindications to bypass procedures (no severe esophagitis, no Barrett’s esophagus) or to patients who require ‘‘restoration’’ of a proper sleeve. In this study, concomitant cruroplasty when needed was safe and effective without recurrence at the 2-year follow-up.
Conclusion LSG revision with fundectomy and associated cruroplasty in patients with HH is technically feasible and has good results in terms of GERD symptom control and additional weight loss at 2 years. Despite this, the high rate of postoperative complications observed in this series remains a matter of concern. A re-sleeve procedure must be considered as an alternative to RYGB conversion, but is restricted to selected patients in centers with bariatric surgeons who have high expertise and skills. Further studies are necessary to prospectively compare the outcomes of fundectomy versus RYGBP or DS after LSG.
Funding No grants or other external sources of funding supported this work. Disclosures Gianfranco Silecchia, Francesco De Angelis, Mario Rizzello, Alice Albanese, Fabio Longo, Mirto Foletto have no conflicts of interest.
References 1. Himpens J, Dobbeleir J, Peeters G (2010) Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg 252: 319–324 2. Gagner M, Deitel M, Erickson AL (2013) Survey on laparoscopic sleeve gastrectomy (LSG) at the fourth international consensus summit on sleeve gastrectomy. Obes Surg 23:2013–2017 3. Brethauer SA, Hammel JP, Schauer PR (2009) Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 5:469–475
4. Weiner RA, Theodoridou S, Weiner S (2011) Failure of laparoscopic sleeve gastrectomy—further procedure? Obes Facts 4(1):42–46 5. Carabotti M, Silecchia G, Greco F et al (2013) Impact of laparoscopic sleeve gastrectomy on upper gastrointestinal symptoms. Obes Surg 23:1551–1557 6. Brethauer A, Kothari S, Sudan R et al (2014) Systematic review on reoperative bariatric surgery. ASMBS Revision Task Force. Surg Obes Relat Dis. doi:10.1016/j.soard.2014.02.014 7. Rengo M, Bellini D, Iorio O et al (2013) Role of preoperative imaging with multi detector computed tomography in the management of patients with gastroesophageal reflux disease symptoms after laparoscopic sleeve gastrectomy. Obes Surg 23:1981–1986 8. Deguines J-B, Verhaeghe P, Yzet T et al (2013) Is the residual volume after laparocopic sleeve gastrectomy an objective criterion for adapting the treatment strategy after failure ? Surg Obes Rel Dis 9:660–666 9. Noel P, Nedelcu M, Nocca D et al (2014) Revised sleeve gastrectomy: another option for weight loss failure after sleeve gastrectomy. Surg Endosc 28(4):1096–1102 10. Tack J, Talley NJ, Camilleri M et al (2006) Functional gastroduodenal disorders. Gastroenterology 5:1466–1479 11. Silecchia G, Iossa A, Cavallaro G et al (2014) Reinforcement of hiatal hernia defect repair with absorbable mesh fixed with non permanent devices. Minim Invasive Ther Allied Technol 23(5):302–308 12. Chiu S, Birch DW, Shi X et al (2011) Effetct of sleeve gastrectomy on gastroesophageal reflux disease: a systematic review. Surg Obes Relat Dis 7(4):510–515 13. Tai CM, Huang CK, Lee YC et al (2013) Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc 27(4):1260–1266 14. Petersen WV, Meile T, Kuper MA et al (2012) Functional importance of laparoscopic sleeve gastrectomy for the lower esophaheal sphincter in patients with morbid obesity. Obes Surg 22:360–366 15. Parikh M, Gagner M (2008) Laparoscopic hiatal hernia repair and repeat sleeve gastrectomy for gastroesophageal reflux disease after duodenal switch. Surg Obes Relat Dis 4(1):73–75 16. Gagner M, Rogula T (2003) Laparoscopic reoperative sleeve gastrectomy for poor weight lossafter biliopancreatic diversion with duodenal switch. Obes Surg 13:649–654 17. Rebibo L, Fuks D, Verhaeghe P et al (2012) Repeat sleeve gastrectomy compared with primary sleeve gastrectomy: A singlecentre, matched case study. Obes Surg 22:1909–1915 18. Shimizu H, Annaberdyev S, Motamarry I et al (2013) Revisional bariatric surgery for unsuccessful weight loss and complications. Obes Surg 23:1766–1773 19. Dapri G, Cadie`re GB, Himpens J (2011) Laparoscopic repeat sleeve gastrectomy versus duodenale switch after isolated sleeve gastrectomy for obesity. Surg Obes Relat Dis 7:38–44 20. Iannelli A, Schneck AS, Noel P et al (2011) Re-sleeve gastrectomy for failed laparoscopic sleeve gastrectomy : A feasibility study. Obes Surg 21:832–835
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and Other Interventional Techniques
Residual fundus or neofundus after laparoscopic sleeve gastrectomy: is fundectomy safe and effective as revision surgery? Gianfranco Silecchia • Francesco De Angelis • Mario Rizzello • Alice Albanese • Fabio Longo Mirto Foletto
•
Received: 26 July 2014 / Accepted: 19 November 2014 Ó Springer Science+Business Media New York 2014
Abstract Introduction Up to 30 % of patients who have undergone laparoscopic sleeve gastrectomy require revision surgery for inadequate weight loss, weight regain, and/or the development of severe upper gastrointestinal symptoms. The aim of this retrospective study was to evaluate the safety and efficacy of laparoscopic fundectomy (LF) in cases of a residual fundus/neofundus development regarding GERD symptoms. Methods The study group comprised 19 patients (17 female; mean BMI 35.4 kg/m2) divided into 2 groups. Group A (n = 10) patients with severe GERD and evidence of residual fundus/neofundus, Hiatal hernia with good results in terms of weight loss. Group B (n = 9) patients with severe GERD, a residual fundus/neofundus, inadequate weight loss or weight regain. Fundectomy was indicated when a residual fundus/neofundus was associated with severe GERD symptoms. The presence of a residual fundus/neofundus was assessed by a barium swallow and/ or multislice computed tomography. Results No mortality or intra-operative complications occurred. Five postoperative complications occurred: 2 cases of bleeding, 1 mid-gastric stenosis and 2 leaks
G. Silecchia F. De Angelis (&) M. Rizzello F. Longo Division of General Surgery & Bariatric Center of Excellence, Department of Medico-Surgical Sciences and Biotechnology, Hospital ICOT, Sapienza University of Rome, Via F. Faggiana 1668, 04100 Latina, Italy e-mail: [email protected] G. Silecchia e-mail: [email protected] A. Albanese M. Foletto IFSO Bariatric Center of Excellence, Policlinico Universitario, University of Padova, Via Giustiniani 2, 35128 Padua, Italy
(10.5 %). All patients experienced improvements in their GERD symptoms and stopped PPI treatment. Group B exhibited an additional %EWL of 53.4 % at 24 months. Conclusion LF and cruroplasty is feasible and has good results in terms of GERD symptoms control and additional weight loss. The high rate of postoperative complications observed in this series remains a matter of concern. A resleeve procedure might be considered as an alternative to RYGB/DS conversion restricted to selected patients. Keywords Fundectomy GERD Hiatal hernia Obesity Revised sleeve gastrectomy
Introduction Laparoscopic sleeve gastrectomy (LSG) has become a very popular bariatric procedure. Although it was originally conceived as a bridging surgery for superobese patients, low complication rates and good 3- to 5-year results in terms of weight loss and resolution of co-morbidities have strengthened the role of LSG as a definitive procedure [1–3]. However, up to 30 % of patients who have undergone LSG require revision surgery for inadequate weight loss, weight regain, or the development of severe upper gastrointestinal (GI) symptoms [mainly gastro-esophageal reflux disease (GERD)] [1, 4]. Weight regain or insufficient weight loss can be successfully managed with conversion to laparoscopic gastric bypass (LRYGB) or duodenal switch (DS), both of which also help to relieve the symptoms of GERD [4]. The appearance or worsening of GERD symptoms after LSG is reported in 20–30 % of cases [1, 4, 5]. Many mechanisms may be involved, including a missed hiatal hernia (HH) during LSG, which can result in postoperative
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transhiatal migration of the upper portion of the sleeve; incomplete gastric fundus resection (residual fundus); neofundus development; or ‘‘de novo’’ GERD due to an incompetent lower esophageal sphincter. The first-line treatment comprising high-dose proton pump inhibitors (PPI) fails in most cases [5]. When GERD symptoms significantly impair patients’ quality of life, regardless of whether the symptoms are combined with insufficient weight loss or weight regain, revision surgery is indicated. Although conversion to LRYGB seems to be the preferred revision approach, resection of the residual fundus or neofundus (fundectomy as the main part of a resleeve) with hiatal defect repair (if present) might be an alternative strategy in some patients [1, 6]. The aim of this retrospective study was to evaluate the safety and efficacy of laparoscopic fundectomy in cases of a residual fundus or neofundus development regarding severe upper GI symptoms.
eating or behavioral disorders. Compliance with the LSG eating pattern was considered to be a selection criterion for fundectomy. The presence of a residual fundus or development of a neofundus was assessed in all patients by a barium swallow after comparison with previous upper GI series performed 30 days after the primary sleeve gastrectomy. (Reviewer 1, third Question) (Fig. 1). Multislice computed tomography (CT) with 3-dimensional reconstruction was performed in 9 patients (Fig. 2). Each scan was performed with a 64-row
Methods We retrospectively analyzed the prospectively collected databases of 2 Bariatric Centers of Excellence. The study group comprised 19 patients (17 female; mean body mass index [BMI], 36.5 kg/m2) who underwent laparoscopic fundectomy with or without crura repair for concomitant HH. The study was approved by the ethic committees of the two hospitals involved. (1 Reviewer, first question). The patients were divided into 2 groups. Group A (n = 10) comprised patients with severe GERD and evidence of a residual fundus, neofundus development, HH, and/or transhiatal migration of the upper portion of the sleeve but with good results in terms of weight loss (percent excess weight loss [%EWL], [50 %). Group B (n = 9) comprised patients with severe GERD, a residual fundus, neofundus development, inadequate weight loss, or weight regain (median %EWL before revision, 19 %) with a mean BMI at the nadir after the primary procedure of 38.3 (36–42.7). (1 Reviewer, fourth question). Laparoscopic re-sleeve (fundectomy) was indicated when a residual fundus or neofundus was associated with severe GERD symptoms that did not respond to a high doses of PPI (Omeprazole 80 mg/BID for 8 weeks) (1 Reviewer, Second question). All patients either had contraindications to or refused to undergo conversion to bypass procedures (RYGB or DS). Fundectomy was not offered to patients when upper GI endoscopy demonstrated severe esophagitis (higher than Los Angeles grade B) (1 Reviewer, Fifth question). or nutritional or psychological contraindications to further restrictive surgery. All patients were referred to a nutritionist and psychologist for the assessment of their eating habits and to undergo screening in search of any
123
Fig. 1 Barium swallow shows residual fundus and migrated sleeve with hiatal hernia
Fig. 2 CT scan shows transhiatal migration of the upper portion of the sleeve with neofundus development
Surg Endosc
multidetector CT scanner in the craniocaudal direction immediately after oral administration of 500 ml of a 4 % solution of iodinated contrast medium and tap water. As previously reported, tridimensional reconstruction was manually performed for the quantification of the sleeve and antrum volumes [7]. Fundectomy was performed in patients with a residual fundus or neofundus development associated with a residual gastric volume [250 ml in agreement with the criteria proposed by Noel [8, 9]. Upper GI symptoms were assessed by a validated questionnaire (Rome III criteria) [5, 10] followed by upper GI endoscopy (1 Reviewer, Fifth question) to rule out mucosal lesions and Helicobacter pylori infection. One month after the surgical procedure, a barium swallow upper GI series was performed in all patients to evaluate the HH repair and/or neofundus excision. The persistence of GERD symptoms was investigated at a minimum follow-up of 24 months using the same validated questionnaire administrated preoperatively.
Surgical technique The fundectomy begun with careful adhesiolysis at the level of the left gastric tube border, taking care to completely dissect the neofundus, and thus obtain complete exposure of the left crus. In patients with a hiatus defect associated with sleeve migration, a complete reduction into the abdomen of the migrated sleeve and at least 4 cm of the distal esophagus was achieved. The fundectomy, calibrated on a 36- to 42-Fr orogastric bougie, was performed with sequential green cartridges (Ethicon Endo-Surgery Inc., Cincinnati, OH, USA) reinforced in 9 patients with bioabsorbable strips (Seamguard tissue reinforcement, W. L. Gore & Associates, 101 Inc., Flagstaff, AZ, USA) and in the remaining 10 patients with fibrin glue (Tisseel, 4 ml; Baxter International Deerfeld, IL, USA). The last shot was fired at least 1.5 cm distal to the esopha-gogastric junction. An intra-operative methylene blue test was routinely performed to check for gastric leakage, and a drain was routinely left in place for 24 h. The hiatal defect was repaired with 2 or 3 non-absorbable stitches approximating the pillars. Large defects ([4 cm2) were reinforced with a synthetic absorbable mesh (BIO A tissue reinforcement, W. L. Gore & Associates, 101 Inc., Flagstaff, AZ, USA) anchored with absorbable tacks and/or fibrin glue [11]. The cruroplasty was calibrated on a 32-Fr bougie.
Results In 8 patients (42.1 %), the LSG was performed as a revision procedure after band failure. According to the Rome
III questionnaire, 13 patients (68.4 %) had symptoms with a score of 3 (daily GERD symptoms), and 6 patients (31.6 %) had symptoms with a score of 2 (GERD symptoms at least 3 times a week). Six patients (31.6 %) were superobese (BMI, 55.2 kg/m2) before primary LSG. The mean time interval between LSG and fundectomy was of 38.7 months (range 12–80 months). The mean BMI before the primary LSG was of 44 (35–55). At the time of fundectomy, the mean BMI was 36.5 (32–52) kg/m2. The mortality rate was of 0 %. In 10 patients, a concomitant cruroplasty was carried out; in 5 patients with a hiatal defect of [4 cm2, the cruroplasty was reinforced with a synthetic absorbable mesh (Gore BIO-A). In all patients, the staple line was reinforced (Seamguard or Tisseel). No intra-operative complications occurred. Five (26.3 %) postoperative complications occurred: 2 cases of staple line bleeding that required blood transfusions, 1 mid-gastric stenosis successfully treated with 3 sequential endoscopic dilations, and 2 leaks in the upper portion of the fundectomy. Both fistulas were treated conservatively with percutaneous drains, enteral feeding, and endoscopic placement of a covered stent (recovery time, 35 and 45 days, respectively). Unfortunately, one of the later patients developed a recurrent esophago-pleural fistula that, after 6 months of unsuccessful conservative treatment, required surgical revision (total gastrectomy with esophago-jejunal anastomosis). Seventeen patients completed a minimum follow-up period of 24 months. After the re-sleeve, all patients had an upper GI series (gastrographinÒ) in the first p.o. day, and then a barium swallow one month after surgery and every 12 months. The comparison of the X-ray series did not show any evidence of a residual fundus nor HH recurrence in Group A patients. (1 Reviewer, question 6). All patients experienced improvements in their upper GI symptoms as assessed by the Rome III questionnaire and stopped PPI treatment within 3 months. Group B exhibited an additional %EWL of 53.4 % at 24 months. The mean BMI 24 months after fundectomy was of 28.8 (23–41.9)
Discussion LSG has been widely accepted as a stand-alone procedure because of its good outcomes in terms of weight loss, low complication rates, and resolution of comorbidities, similar to RYGB [1–3]. However, about 10 % of LSG procedures are followed by insufficient weight loss or weight regain, and up to 40 % of patients complain of upper GI symptoms that significantly impair their quality of life and decrease patient satisfaction [5]. Weiner et al. recognized two mechanisms of weight regain: loss of restriction and/or
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changes in eating behavior [4]. Himpens et al. reported significant weight regain between the third and sixth postoperative years associated with symptomatic GERD that occurred with an incidence of up to 22 % after 1 year [1]. The occurrence or persistence of GERD remains a controversial issue. In their systematic review, Chiu et al. reported that most studies did not find an increase in the occurrence of symptomatic GERD after LSG [12]. Tai et al. reported that postoperative GERD and esophagitis were related to the presence of HH [13]. Petersen et al. postulated that LSG plays a role in the increased lower esophageal pressure regardless of weight loss after LSG and may protect patients from postoperative GERD [14]. Himpens’s group demonstrated a biphasic pattern after LSG. The first peak of GERD developed during the first year after surgery, and the second peak of GERD developed later and was associated with neofundus appearance [1]. The development of a neofundus or the presence of a residual fundus might be involved in weight regain and postoperative GERD. The undissected residual fundus or the development of a neofundus with a concomitant hiatal defect is considered to be a risk factor for symptomatic reflux, and fundectomy with concurrent cruroplasty has been advocated as a valid treatment option [15]. The revised LSG (rLSG) is a relatively new option, and data on its outcomes are very limited. The rationale of this technique is to resize the sleeve when dilation appears on an upper GI series or CT scan volumetry scan. Evaluation by a radiologist is crucial for accurate assessment of the volume and shape of the fundus and concomitant intrathoracic migration. Based on radiological studies by Braghetto, a threshold of 250 cm3 has been proposed as the indication for eventual fundectomy [17]. The rLSG reduces acid production and restricts additional weight loss. Multidisciplinary assessment is mandatory in patients with severe GERD (gastroenterologist consultation, endoscopy, and pH manometry if indicated) and insufficient weight loss or long-term weight regain to rule out concomitant contributive factors (binge eating disorders, sweet eating, or detrimental eating patterns). The indications for and technique of fundectomy after rLSG are still debated, and no long-term data are available. The first rLSG was reported by Gagner and Rogula and showed good results in terms of complications and efficacy (additional EWL) [16]. Dapri et al. observed a leakage rate of 14.2 % in a series of 7 patients (Table 1) [19]. Rebibo et al. reported a series of 15 patients with a %EWL of 66 % at the 12-month follow-up, a complication rate of 20.0 % including 2 gastric fistulas (13.0 %), and a mortality rate of 6.6 % [17]. Noel et al. presented the largest series of patients undergoing rLSG (n = 36) without complications or mortality and with a mean %EWL of 53.4 % at a mean follow-up of 14.5 months [9]. The main advantages
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Table 1 Re-sleeve gastrectomy complication rate Authors
Year
N. Pts
Dapri et al. [19]
2010
7
Complication rate (Overall)
Leak
14.20 %
14.20 %
Iannelli et al. [20]
2010
13
Rebibo et al. [17]
2012
15
0
Noel et al. [9]
2013
36
2.70 %
Current study
2014
19
26.30 %
20.00 %
0 13.30 % 0 10.50 %
advocated for rLSG over bypass procedures are no risks of anemia, vitamin deficiency, or osteopenia; a decrease in acid production and ghrelin; and preservation of the pylorus. The purpose of this retrospective study was to evaluate the safety and efficacy of fundectomy regarding GERD symptom control and/or additional EWL when insufficient weight loss or weight regain was present in a selected group of patients. This is the first study to assess the effect of fundectomy in a subgroup of patients with good %EWL and comorbidity control but with severe and persistent upper GI symptoms unresponsive to medical treatment (Group A). The recent systematic review of the ASMBS Revision Task Force, suggest the conversion to LRYGB in case of severe GERD post-LSG refractory to PPI treatment as effective option [6] (Reviewer 2 comment). In our series, the patients in Group A did not show severe esophagitis on upper GI endoscopy. Six patients refused conversion to a bypass procedure, and such procedures were contraindicated in 4 patients because of post-thyroidectomy/ parathyroidectomy osteopenia or hypocalcemia requiring chronic calcium and vitamin D supplementation. Our 26 % rate of postoperative complications is similar to that in previous studies [17, 19]. The results of the present study confirm that revision bariatric surgery has a higher complication rate [18]. The incidence of leakage in the present series was of 10.5 % (Table 1). Resolution of GERD symptoms was observed in 16 patients (9 in Group A and 7 in Group B) at the 24-month follow-up with an additional %EWL of 53.4 % (Group B). This study has several limitations, including its retrospective nature, limited number of patients, short follow-up period, lack of fundus volume evaluation by CT scan volumetry in all patients, lack of routine postoperative upper GI endoscopy, and lack of pH manometry to assess GERD. However, this is the first report of LSG by laparoscopic fundectomy as a revision surgery mainly for severe upper GI symptoms and weight loss failure with a 24-month follow-up period. GERD symptoms were assessed in all patients with a validated questionnaire, and upper GI endoscopy was used to evaluate the presence of
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esophagitis, which represented the main indication/contraindication for fundectomy. The results of the present study suggest that fundectomy effectively controls upper GI symptoms in 90 % of patients at 24 months postoperatively. An additional %EWL was achieved in all patients with insufficient loss or weight regain. This option can be offered to selected patients with contraindications to bypass procedures (no severe esophagitis, no Barrett’s esophagus) or to patients who require ‘‘restoration’’ of a proper sleeve. In this study, concomitant cruroplasty when needed was safe and effective without recurrence at the 2-year follow-up.
Conclusion LSG revision with fundectomy and associated cruroplasty in patients with HH is technically feasible and has good results in terms of GERD symptom control and additional weight loss at 2 years. Despite this, the high rate of postoperative complications observed in this series remains a matter of concern. A re-sleeve procedure must be considered as an alternative to RYGB conversion, but is restricted to selected patients in centers with bariatric surgeons who have high expertise and skills. Further studies are necessary to prospectively compare the outcomes of fundectomy versus RYGBP or DS after LSG.
Funding No grants or other external sources of funding supported this work. Disclosures Gianfranco Silecchia, Francesco De Angelis, Mario Rizzello, Alice Albanese, Fabio Longo, Mirto Foletto have no conflicts of interest.
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