In this prospective case series study 800 cases were included. The mean age of patients was 27.5 years old (12-65). Nine patients less than 18 years old (adolescents) also were included in the study whose indication for surgery was high speed of weight gain and risk of super obesity. For adolescents, Excess weight loss (EWL) was generally the same as adults. 9 adolescent patients had 54% EWL after 6 months and 62% after 12 months. In all the ratio of female to male was 650 to 150 (81% to 19%). Mean BMI of patients was 42.1 (35-59). The mean EWL was 20% (13% to 40%) after one month (779 cases), 35% (20% to 60%) after 2 months (745 cases), 45% (25% to 75%) after 3 months (711 cases), 60% (28% to 100%) after 6 months (615 cases), 67% (35% to 100%) after 12 months (491 cases), 70% (40% to 100%) after 24 months (356 cases), 66% (35% to 100%) after 3 years (251 cases), 62% (30% to 100%) after 4 years (176 cases) and 55% (28% to 100%) after 5 years (134 cases) following surgery. The average time of follow up was 5 years (one month to 12 years). 134 (16.7%) cases were lost to follow-up in long term and partially included in EWL results (Table ).
Excess weight loss after LGP
The technique of laparoscopic gastric plication (LGP) was performed in all cases including those with large fatty liver, hiatal hernia and adhesions from previous operation. Sonography showed gallstone in 52 cases (6.5%) and cholecystectomy was performed at the same time. History of cholecystectomy was positive in 21 cases (2.6%).
Fatty liver was reported in 85% of cases (682 cases) by sonography in different grades including: 421 cases (52%) grade G1, 154 (19%) cases G2 and 107 cases (13%) G3. After one year of LGP report of fatty liver by check-up sonography was as below: 211 out of 242 cases (87%) of G1 recovered completely, 45 cases out of 91 (49%) of G2 recovered completely and 27 (29%) of them changed into G1,35 out of 102 cases (34%) of G3 recovered completely and 48 cases down staged (47%).
The average anatomic volume of stomach in the operating room was 100 and 50 cc in one- and tow-row plication respectively. But The functional volume of stomach in one- and two-row LGP respectively was about 25 and 15cc at first, 50 and 25cc after 2 weeks, 75 and 45cc after6 months, 100 and 60cc after 1 year and 250 and 150cc after 4 years (Figure ). The functional volume was highly related to the kind of food. If the patient was eating something rich of proteins the amount of functional intake was considerably less compared with the time something with high carbohydrate ingredients was taken. In some especial form of diet such as plain water or sweet water etc. the functional restriction did not happen until the anatomic volume was reached. The appetite of patients decreased after operation due to total gastric volume restriction. They described this feeling as like the condition after eating more than usual with complete fullness of stomach.
Trend of functional intraluminal space changes in 2 methods of LGP.
The weight loss curve had prominent slope during first 6 months but for next 18 months showed decreased rate (Figure ).
EWL after LGP, A Mean Percentages of EWL from baseline amount during 5 years of follow up; B Mean Percentages of EWL from baseline amount during 5 years of follow up and their variance in cases and its range as vertical lines.
Mild to moderate weakness during first 3 weeks was common. Vomiting and nausea was seen in all of cases for at least 4 hours and the longest time was 24 days (average time was 2.1 days) which resolved spontaneously. Epigastric pain was seen in 35% of cases for 48 hours which relieved quickly by antacids. Temporarily during the first Postop week, reflux was seen in 16% (128 out of 800) of cases without any preop history of reflux symptoms. It changed to less than 2% after 3 months concurrently with about 45% EWL.
16 patients out of 615 had problems after 6 months which only one of them required reoperation to undo the plication due to long term vomiting secondary to adhesion of liver to the His angle. Others including 2 patients with gastritis and 13 with persistent reflux were controlled by medical therapy (Table ).
Postoperative problems after LGP
The price of hospitalization and instruments used in gastric plication was 2000$, while gastric bypass would cost 4500$ and sleeve or banding 4000$ in Laleh Private Hospital [28
The rate of unrelated complications was 0.6% (5 cases out of 800). In two cases, non-obstructive jaundice appeared for more than 2 weeks after operation which resolved spontaneously. Liver enzymes were very high. The etiology was drug induced hepatitis.
Symptomatic hypocalcemia was seen in one patient secondary to lack of intake. She had hypercalciuria in her past medical history and since she got enough calcium supplements, became asymptomatic. Aspiration pneumonia occurred in one subject who underwent 2 weeks postoperative treatment. Mild bleeding due to anticoagulation therapy was seen in one case which stopped by conservative management and 2 units of fresh blood transfusion. Although dissection of greater curvature was with the risk of bleeding but in our cases blood transfusion was needed only once.
Postoperative technical complications were seen 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 prepyloric 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 completed after 45 days and drains were taken out afterwards.
Intrahepatic hematoma due to fan retractor manipulation predisposed intracapsular liver abscess formation after 6 months in one case. The hematomas did not occur again due to using the new question mark liver retractor.
Postoperative obstruction presented by continuous vomiting was seen in three cases due to displacement of released fundus outside the suture line and extra-expansion. But instead of dilation at needle insertion point or blowout, 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.
In another case due to unusual adhesion between fundus and traumatized liver, permanent vomiting and discomfort was seen. Actually in this case laparoscopic reoperation 8 months later resolved the problem. In this surgery the adhesion was released and plication was undone.
Undoing of LGP in first case by cut of thread and separation of folds performed with limited adhesions. In second one adhesion between folds was really strong and separation was hard (Table ).
Postoperative complications after LGP
156 and 644 cases underwent one- and two-row plication respectively. All of complications were seen in former technique except two obstruction cases in the latter (0.3%). Comparing EWL showed it was the same at first but higher at long term due to less anatomic volume and prominent functional restrictive effect in two-row technique. (50% and 65% after 6 months, 62% and 75% after 12 months, 65% and 77% after 2 years, 60% and 75% after 3 years and 56% and 70% after 4 years in one- and two-row respectively) (Figure ).
Comparing Excess Weight Loss between one- and two-row LGP.
Reoperation due to regain (32), failure (6) or other reasons (gallstone 12, appendicitis 3) was done in 53 cases and plication rechecked. These cases showed unchanged suture line but little expansion of the stomach (Figure ). Fibrotic bands around plication had reinforced it. In 25 out of 38 cases of regain or failure, outside displacement of plicated fold was seen (65%).
Plicated stomach after 3 years.
The rate of late (after 1 month of operation) postoperative complication was zero. Some comorbidities was present before surgery in 18% of cases including 11% diabetes, 5% knee or low back pain, 4% hypertriglyceridemia, 1% hypertension, and 0.5% sleep apnea. Six months and one year after operation, respectively 70% and 95% of diabetic cases changed into non diabetics (40% after 2 months) and the remaining needed to taper their medical therapy; 80% and 100% knee or low back pain, 40% and 70% of hypertriglyceridemia, 50% and 80% of hypertension and all of sleep apnea cases recovered from diseases. 2 cases out of 55 regain patients complained of diabetes again (Table ).
Comorbidities in LGP cases and the recovery percentage
The mean time of operation was 72 (49–152) minutes; all were discharged after an average time of 72 hours (24 hours to 45 days). It was 100 minutes when dissection of greater curvature was done by coagulation and suture and 67 minutes when it was done by LigaSureTM or Ultracision.
Regain and failure
In experience there was about 31% regain after up to 8 years of effective time (4 year period) of operation (55 out of 176), which was 5.5% up to 4 years after operation (26 out of 490) and 42% after 10 years (15 out of 35). Cases with less than 30% EWL after 4 years were included in regain group. We put 6 failure cases with less than 30% EWL during first 6 months in it as well.
The main regain and failure group was cases with wrong selection of technique, mainly males without good motivation and co-working (31 regain and 6 failure cases). The plan for this group was malabsorptive operation that has done in 20 cases with excellent EWL (78% EWL after 1 year). The second group was cases with good result secondary to plication, but due to new conditions (like marriage, pregnancy and psychological disease secondary to familial problems like divorce, death of relatives and so on) lifestyle of patient has changed again. Patients with temporary change of conditions like pregnancy can be managed by replication or gastric bypass. But if the new condition was permanent, the method of choice was malabsorptive. In 11 out of 18 such cases we did replication, gastric bypass in 2 and malabsorptive in 5. The mean EWL after 6 months of replication in these cases was 44% and after 1 year it was 51% with mean follow up time of 24 months (55%) (Table ).
Regain or failure after up to 8 years of effective period of LGP (4 years)