Laparoscopic greater curvature plication for treatment for morbidly obese patients: Early experience of Alexandria University

Laparoscopic greater curvature plication for treatment for morbidly obese patients: Early experience of Alexandria University

Mohamed A Sharaan, MD;  Khaled Katri, MD;  Mohamed Hany, MD;

WaleedAbdel-Haleem,MD;  Tamer AbdelBaki, MD  Department ofGeneral  Surgery, Alexandria University, Alexandria ,Egypt.

Correspondence:

Mohamed Abdallah Sharaan, Department of General Surgery, Faculty  of

Medicine, Alexandria  University, Egypt.

Abstract

Background: Gastric restrictive  procedures currently performed  for morbidly  obese patients include  either  gastric  resection  by Laparoscopic Sleeve  Gastrectomy or by implanted device (Laparoscopic Adjustable Gastric  Banding). We present  our  early  experience of a feasibility study  using  Laparoscopic Gastric   Greater  Curvature Plication  (LGGCP)   for  weight  loss instead  of stapling  or banding.

Methods: After  approval  of the Ethical  Committee of Alexandria University Hospital, and taking  an  informed   consent  from  our  patients,  we  performed  LGGCP  in  68  patients.  After mobilization of the greater  curvature,  it was folded  inwards  by two layers  of non-absorbable sutures.

Results:  Our  average  Body  Mass Index  (BMI)  was  42  kg fm2,  mean  operative time  111 minutes.  There  was no conversion to laparotomy.  The  mean percentage of excess  weight  loss (EWL)  at 10 days, 1 month, 3 months,  6 months and 12 months were 10%, 16%, 25%, 35%, and

56% respectively. No intra-operative complications, no mortality, 5.8% major complications in the form of one case of fundic herniation that required laparoscopic partial  gastrectomy, and 3 cases of obstructed pouch,  one required undo-plication, the other one was relieved  by medical treatment,  and the last one improved  by upper endoscopic dilatation.

Conclusion: Our early experience has suggested  that LGGCP  is a successful  way to reduce the stomach capacity,  and an acceptable early weight loss. LGGCP  is safe and feasible but it is not without  complications. Prospective randomized study between  LGGCP  and Laparoscopic

Sleeve Gastrectomy is needed.

Introduction:

Morbid obesity is a well-recognized growing health problem worldwide.! Diet, exercise,  and  or  medication  as a treatment have not demonstrated sustainable clinically significant results.2 Bariatric surgery has a positive impact as a primary therapy for the treatment of obesity and its comorbidities. However,   there   is   a   significant    debate

concerning    which     patients     are     optimal candidates for which procedures.3,4

Many types of restrictive procedures have been performed to achieve weight loss.5 Most of these procedures have been abandoned because of poor long-term weight loss, food intolerance,  or  severe  gastro-esophageal reflux and complications. The main aim of these procedures  was to design the stomach

into     proximal     stomach     horizontally     or vertically with a small outlet. Vertical banded gastroplasty, in particular, has resulted in poor long-term  outcomes,  and a high  percentage of vertical banded gastroplasty patients have required revision to Roux-en-Y gastric bypass to alleviate  intolerable reflux symptoms and dysphagia or to achieve weight loss again.6-12

Laparoscopic adjustable gastric banding and sleeve gastrectomy are currently the well­ known gastric restrictive procedures. The risk of gastric slippage, band erosion associated with the gastric band, and the risk of gastric leakage with sleeve gastrectomy   has limited the acceptance of these procedures by some patients and surgeons. Recently, endo-luminal procedures have been developed to achieve a similar  restrictive  effect  without  subjecting the patient to the riskofsurgery.l3-14 However, these endoscopic procedures were not durable because they entail approximation of mucosa of opposing gastric walls.l4 The aim of the present study was to assess the feasibility, safety  and  early  outcome  laparoscopic greater curvature plication (LGCP), which is a new restrictive bariatric surgical technique that creates gastric restriction without the use of an implant and without performing gastric resection and so eliminates the complications associated with gastric band and Sleeve Gastrectomy.

Methods:

From April 2011 to April 2012, we prospectively   performed   Laparoscopic Gastric Greater Curvature Plication (LGGCP) to 68 obese patients. This procedure was approved by the ethical committee of the hospital, and all patients signed an informed consent before going to surgery and received a pre-operative prophylactic dose of low molecular weight heparin. Inclusion criteria were  BMI above 35 kg!m2, age from  18 to

65 years, patients with no previous gastric surgenes.

The exclusion criteria included pregnancy

or lactation at screening or surgery, a documented history of drug and/or alcohol abuse   within   2   years   of   the   screemng visit,  previous  malabsorptive   or  restrictive

procedures    performed    for   the   treatment of obesity, the participation in any other investigational device or drug study within 12 weeks of enrollment, severe cardiopulmonary disease or other serious organic disease, uncontrolled hypertension, and portal hypertension, and patients on hormonal therapy.

Surgical procedure:

All our patients were subjected to general anesthesia, and positioned supine and legs opened wrapped by elastic bandage or elastic stocking.  Trocar placement  was  as follows: one 10-mm trocar above and slightly to the right of the umbilicus for the 30° laparoscope; one 10-mm trocar in the upper right quadrant (URQ) for  passing the  needle, for suturing, and for the surgeon's  right hand; one 5-mm trocar  also  in the  URQ  below  the  10-mm trocar at the axillary line for the surgeon's assistant; one 5-mm trocar below the xiphoid process for liver retraction; and one 5-mm trocar  in the upper left quadrant  (ULQ) for the surgeon's left hand. The procedure began with the dissection of the Greater Curvature of the stomach 6cm proximal to the pylorus extending until reaching the Angle of His and the  removal  of the fat  pad in this  location, using the HarmonicTM scalpel (Ethicon Endo­ Surgery, Inc., Cincinnati, Ohio). Once the access to the posterior wall was achieved. Occasionally,  posterior  gastric  adhesions were also dissected to allow optimal freedom of the stomach to facilitate creation of the invagination easily. Then we allowed passage of  a  calibrating  tube  32-Fr  Bougie,  to  be placed near the lesser curvature, then initiate gastric plication by taking non-absorbable sutures  invaginating   the  greater  curvature over the tube,  starting 1-2cm from the angle of His, with fixation of the fundus by the first suture. Then continuing  the application of the first row of extra-mucosal interrupted stitches of 2-0 Ethibond™ (Ethicon, Inc., Somerville, NJ, USA) sutures. The distance between each suture of the first row was at least 2cm. This row was followed by a second subsequent row created  with  extra-mucosal  running  suture of 2-0 ProleneTM (Ethicon, Inc., Somerville, NJ,   USA).    Leak   tests    were   performed

with  methylene blue in all cases. Upper  GI endoscopy was routinely performed in all of our cases to assess the final stomach capacity and  to  confirm  the  patency  of  the  created gastric pouch. A drain was placed beside the suture line in all of our cases. Postoperatively, patients  were  followed  and  monitored  for any  complications  and  discharged  as  soon as they  tolerated  fluid  diet  and  received  a daily  proton-pump   inhibitor,  for  6  weeks, anti-emetic    (Ondasentron)    and   the    anti­ spasmodic  (Hyoscine)   were  prescribed  for

7 days. The postoperative  diet of fluids for

2 weeks, then soft diet for another 2 weeks, and starting semi-solid and solid diet in a stepwise fashion, while restricting sweet diet. We followed the patients   1 week and then at

1, 3, 6, 12 & 18 months in the postoperative

period. Gastrograffine study of the created gastric pouch was scheduled once 12 months postoperative.

Results:

Our study included a total  of 68 patients,

18 males (26.4 %), 50 females (73.6%). Their mean age was 35 years (range 18-65 years), their  mean  weight  was  116  kg  (range  80-

192  kg) and  the  average  preoperative  BMI

was  42 kgf m2 (range  32.5-67.1).  The  mean operative  time  was 111 minutes  (range  70-

180  minutes).   The  mean   hospital   length

of  stay  was  25.92  hours.  All  procedures were   performed   laparoscopically    without convergence   to   laparotomy.   On   average, patients returned to normal activities 5 days (4 to 13 days) following surgery. Mean total weight loss (TWL) was calculated to be 7% TWL at 3 months (5 patients), 10% TWL at 6 months (7 patients), 14.7% TWL at 12 months (10  patients)   postoperatively   respectively. Mean  percentage  of excess  weight  loss (% EWL) was calculated to be 10% EWL at 10 days, 16% EWL at 1 month, 25% EWL at 3 months, 35%  EWL at 6 months,  56% EWL at  12  months  postoperatively   respectively. No      intra-operative      complications      were documented.   In  the   postoperative    period we  recorded   55%  of  cases  had  recurrent vomiting  in the  first  week  postoperatively. These cases were responding well to medical

treatment. About 84% of cases complained of recurrent colicky abdominal pain which was exaggerated in response to fluids, this was in the first postoperative week, it was relieved by fixed dose of anti-spasmodics   for about

1  week.  We had three  cases  of  obstructed

pouch, which were all presented by recurrent vomiting  including  their  saliva,  abdominal pain, and severe colicks, and it was confirmed by   gastrograffine   study   denoting   failure or difficult passage of the dye through the pouch. The first  case was narrowed  inlet of the pouch by infolding  of the gastric fundus obstructing   the   osophago-gastric   junction, this case was mild degree and was improved by medical treatment,  while the second case was the same as the first one but in moderate degree and was relieved by endoscopic dilatation ofthe inlet ofthe pouch. The third case of obstructed pouch was at the outlet, was discovered also by gastrograffine  study, was not  improved  neither  by medical  treatment nor by endoscopic dilatation for 4 weeks, so a decision for laparoscopic  undo-plication was taken and we removed  all the stitches at the outlet of the pouch,   and the case improved well  after  the   procedure   without   leakage which was confirmed also by gastrograffine study. We had a case of fundus herniation between the first stitch and the osophago­ gastric junction, this case was persistently complaining of left shoulder pain and colicks not improving by medications without vomiting, fever or even intra-abdominal collection, we discovered it by gastrograffine study and CT scan, so a decision  was made to re-operate this case laparoscopically, we found a big sized herniated stomach elevating and adherent to the diaphragm and the spleen, it was viable stomach  but hugely distended

, so we removed stitches in the neck of herniated stomach and in an attempt to dissect its adherence with the spleen and diaphragm we  discovered  that  it  was  perforated  and sealed with its adherence with diaphragm, so we aspirated its contents and we did a partial gastrectomy  to  it by stapler  (Echlon 60mm gold  fire),   we  added  suture   overseweing the staple line. This case passed a smooth postoperative   course   without   any  leakage

·.

e-

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              /

Figure (1): Trocar sites in LGGCP, a. Camera trocar JOmm, b. Right hand trocar and needle insertion trocar JOmm, c. Liver retractor trocar 5mm, d. Left hand trocar 5mm, e. Assistant trocar 5mm.

Figure (2): Intra-operative picture of the first rows of interrupted non-absorbable sutures.

Figure (4): Final intra-operative picture of

LGGCP.

Figure (3): Intra-operative picture of the second row of continuous non-absorbable sutures.

Figure (5): Intra-operative endoscopic view ofLGGCP.

Mean %EWL

60---------------------------,

..,._Mean %EWL

10

10 days    1month   3 months  6 months 12 months

Figure (6): Mean percentage of excess weight loss expressed in %EWL with the LGGCP

procedure at 10 days,1, 3, 6 and 12 months.

Figure (7): Post-operative endoscopic view of obstruction of the inlet ofLGGCP pouch by the gastric fundus.

Figure (8): CT abdomen with oral contrast showing bigfundus herniation.

Table (1): Comparison between the present study and other studies in LGGCP.

.

P<lbf<lts              Opera twe time          Me.-.nBMI j "EWlll 1M     !lo£Wl31>4         " EWl6M     EWLllM            101Coml)l itations

Ramos r1. alf••                              2         SOmn                           4 1                         10                         32                       48          60                                 no

$teras et a1 Ul1                    135                  58         39.5               ·-            34       51                       67         U09t.

lalebpour etal'" 1            800                             72                              41           10                                                    60                       67            1.60"

._    Our  Pte ent Study               68                            1))                                 2          16                         1S                      35                       56            S,8 "

J

confhmed by gastrograffine study. There has been no record of weight regain in any patient to date.

Discussion:

Bruiat:Iic procedures  reducing  stomach capacity to promote mechanical resn·iction to food intake is one of the n·aditionally accepted

mechanisms used to promote weight loss. There ru·e at least two smgical procedures that apperu· to rely on this principle, Adjustable Gasn·ic Band (AGB),  and  Vertical Sleeve Gasn·ectomy (VSG).16 AGB has been used for  many  yeru·s and  offers  surgical  ease, adjustability, reversibility as well as low immediate mortality and morbidity rates. IS In

terms of weight loss, AGB achieves  around

50% EWL, but unsatisfactory weight loss occurs  in  more  than  20%  of  patients.l5,19

AGB also has the disadvantage of requiring a long-term  implant, which has been shown to dislodge and/or erode in the stomach in up to 11% of patients.ZO This suggests a failure rate requiring surgical revision in up to 25% of  patients.25 These  secondary   procedures can be challenging  and difficult.21 VSG is a procedure  initially used as the first stage of a definitive bariatric treatment known as the duodenal  switch.22 Vertical  gastrectomy  of the greater curvature  is performed, resulting in a tubular stomach with the purpose of restricting food intake. As a primary bariatric procedure, medium-term results have been shown  to  be  adequate  (greater  than  60% EWL), with improvements  in co-morbidities such   as   type   2   diabetes,   hypertension, and  obstructive  sleep  apnea  in  more  than

65%  of  cases.23  These  promising   results

are   associated   with   some   complications, however,     such     as          esophagites,                   stenosis, fistulas,  and gastric leaks near the angle  of His. These leaks and fistulas are reported in nearly 1% of cases and can be very difficult to treat.l 7,22,24 The bariatric procedure that offer restriction of gastric capacity without adding a permanent  implant also  without  resection and stapling  of the stomach  with possibility of leaks, are highly  desirable. Laparoscopic Greater   Curvature   Plication   (LGGCP)   is a  relatively  new  technique.  It was  initially proposed by Wilkinson and Peloso27 in 1981 and introduced  in 2006 by Dr Talebpour in Iran.26 It is similar  to  Laparoscopic  Sleeve Gastrectomy  (LSG) as they both resulted in gastric tube formation and elimination ofthe greater  curvature.  However, LGGCP spared gastric resection  and the use  of an implant. The   advantages   of   LGGCP   that   mostly influenced the patients' decision-making were the  minimal  invasiveness  of  the  operation, the lack of gastric resection, the absence  of foreign bodies, and the convenient follow-up.

In two separate papers, Fusco et al, report efficacy   in   gastric   plication   procedures, as measured by changes in the weight progression of rats_28,29 In one paper, Fusco et

al, reported an increased effect from plication of  the  greater   curvature   when  compared to plication of the anterior surface. These results are in agreement with initial clinical reports by Brethauer et al, who reported an increased weight loss in patients receiving LGGCP when compared to plication of the anterior surface.30 In the present study, there were no convergence to laparotomy  and the mean operative time was 111 minutes, mean hospital  stay 25 hours,  mean excess weight loss was 25% at 3 months, 35% at 6 months, and 56% at 12 months. Ramos et al., in their series of 42 cases,4 reported a mean operative time of 50 minutes (40-100 minutes) and a mean  hospital  stay  of 36 hours (24  to  96). Mean TWLon 1, 3, 6, 12, and 18months from the operation was 10%, 15%, 22%, 28%, and

30%, respectively,  with mean % EWL 20%

for the 1st month, 32% at 3months, 48% at

6 months,  60%  at  12 months,  and  62%  at

18 months. Only minor complications were observed, with symptoms such as nausea vomiting and sialorrhea up to 35% resolving spontaneously within 2 weeks.4

In  the  present  study,  we  reported  three cases of obstructed pouch, in two of them the cause was due to fundic mucosa obstructing the osophago-gastric  pouch, one of them improved by medical treatment the other one improved by upper endoscopy and dilatation, while in the third case the obstruction was at the incisura angularis, and did not improve by any means, so reoperation and undo-plication of  the  two  layers  of  the  last  4cm  of  the pouch was done. This was under endoscopic guidance and the case passed a smooth post­ operative course without any leak. Brethauer et aPl reported one case of obstruction of the gastric lumen by the intraluminal fold after LGGCP, this was in the area of the incisura and they claim that this area is particularly at risk of this complication  if the  intraluminal fold infringes on the lesser curvature or creates a kink in the lumen. They also claimed that this problem can be managed conservatively until edema of the mucosa subsided, but the patient had intolerablilty to fluids so they re­ operated on him by removing the outer row of sutures, and replicating the outer row more

This  patient  did  well  after  the  reoperation, and had excellent weight  loss.31

Talebpour  et  al,32 reported  in their  large study   including  800   cases,  three   cases  of pouch     obstruction   due    to    displacement of  released   fundus   outside   the  suture   line and extra-expansion the  displaced folds stretched  the string, tightening the rest of the knots  especially the  last  one  near  pylorus. The  stomach outflow   kinked  and  produced an obstruction. The management was via laparoscopy. The suture  line was undone  and replication performed. The  last  tie  close  to the pylorus  was done relatively looser than before.  We believe  that  an important step in the  LGGCP  procedure   is  loose  suture  near the incisura angularis, and an intra-operative upper endoscopy to avoid  risk of pouch obstruction.

In  the  present   study,  we  had  a  case  of

fundus   herniation  outside   the  stuture   line, with  sealed  perforation that  required re­ operation by laparoscopy and resection  of the herniated stomach  with  over-running suture. This patient passed a smooth post-operative course and had an excellent weight  loss.

Also   in  their   large   series   of   LGGCP,

Talebpour et al,32 had postoperative technical complications in  8  cases  out  of  800  (1%). Micro perforation occurred  in three cases; the first one occurred at the site of gastric holding by  grasper   at  pre-pyloric  area   which   was closed by simple suture without any change in plication via laparotomy; one case at the site of needle  insertion  at upper  end of plication due  to  increased intraluminal  pressure   and its  dilation  in  one  point  which  was  treated by simple  suture by laparoscopy; and the last one  due to  fundus  sliding  outside  of suture row and blowout  of dilated  displaced fundus. Treatment of this case was by laparotomy, undoing the suture line and drain insertion. During  follow  up  it took  about  2 weeks  for fistula to evolve and closure of fistula was completed  after   45  days   and   drains   were taken out afterwards.

In our present  study  we had  no mortality,

no  weight  regain,  5.8%  major  complication

(4 out of 68 cases)  in the form  of obstructed

technique later on in patients not included  in this study, by taking the first row interrupted non absorbable sutures but taking it in four points sothattherewill be 3 small folds instead of one  big fold.  This is to avoid  obstruction of the pouch in the osophago-gastric junction and at the level of the incisura  angularis. Also by this technique the fundus  will be fixed and it cannot  slide to herniate. We believe that LGGCP  is not without  complications, taking the benefit of learning for our and other complications is important issue to avoid  its occurrence.

Conclusion:

Our  early  experience has  suggested that LGGCP is a successful way to reduce the stomach capacity, and an acceptable early weight   loss.   LGGCP   is  safe   and  feasible but it is not without  complications. We did modifications of the technique of suturing  to avoid the related complications. Prospective randomized study between  LGGCP and Laparoscopic Sleeve Gastrectomy is needed.

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