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Reinforcement

Reinforcement with Seamguard following LRYGB effective

Study examined outcomes from LRYGB with and without Seamguard reinforcement (stapling)

The laparoscopic Roux-en-Y gastric bypass (LRYGB) is a common procedure and its success has been well-documented in the literature. However, one drawback of the procedure is blood loss that originates from the stapling the stomach, as well as recorded instances of leakage. As a result, Dr Philippe Topart, Clinique de l'Anjou, France, decided to investigate the outcomes from LRYGB with and without Seamguard reinforcement (stapling).


The study was designed to evaluate the benefit of a systematic gastric staple line butressing with Seamguard (totally absorbable polyglycolic acid co-polymer) in LRYGB. The primary endpoint of the study was to assess the change in blood loss (originating from stapling the stomach) with the use of Seamguard reinforcement. The Secondary endpoint was to evaluate the sealing of the staple line/leakage rate.


The Seamguard Bioabsorbable Staple Line Reinforcement (WL Gore) is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.


Patient numbers


Topart said that a review of the published data did not present a clear determination of the number of patients required for the study. The investigators therefore based the number of prospective patients required on their own experience.

The investigators estimated that the average post-operative blood loss is 200ml with a standard deviation of 100ml over three days. Based on this assumption, they calculated that the total number of patients (control and Seamguard groups) required would be 60 if the expected reduction of the mean drainage volume was 100ml, and 82 patients for an expected drainage volume reduction of 85ml.


Pre-operative data was collected on age, sex, comorbidities, haemoglobin and peri-operative data was collected on gastric loads, blood loss volume, seamguard or not, haemostatic clips required (gastric staple line only), duration of operation and exceptional events (conversion to open). Post-operative data was collected on complications, haemoglobin on day one and two, fluid drainage on day one, two and three, metylene blue test on day one before resuming oral fluids and soft food, and barium swallow scheduled on day two.


Exclusion criteria


Patients excluded from the study included those with a history of hiatal surgery or bariatric procedure, significant additional surgical procedure scheduled with the bypass (other than cholecystectomy, umbilical hernia repair), and peri-operative exclusion for follow up data because of significant bleeding due to liver/spleen/short gastric vessels.



Procedure


Identical laparoscopic procedures were performed by two surgeons working at the same institution, the only difference was the use of Seamguard as reinforcement of gastric staple line exclusively (Gold loads on Echelon 60 stapler, linear GastroJejunal (GJ) anastomosis with blue load, JejunoJejunal (JJ) and bowel stapling with white loads). Temporary procedure alteration with closure of the mesenteric defect at the JJ Junction.


Outcomes


Following recruitment, three patients refused to be enrolled, three patients ‘converted’ to sleeve gastrectomy and were not included in the study. One patient was excluded due to short gastric vessel bleeding (remains in control group but data not included). The results are shown in Tables 1 and 2.


Table 1: Results from control and Seamguard groups

Control Seamguard
Sex 14 M/27 F 8 M/F 33
Age 41.7 ± 9.8 years 42.8 ± 10.8
BMI 44 ± 3.9 44.6 ± 4.3
Comorbidity 24 patients at least 1 16 at least 1
T2DM 11 13
Hypertension 13 11
Sleep Apnea 14 10
Food resumed day 1 1.10 ± 0.5
Complications 1* 9 (21.9%)**

*naso gastric tube for 48 hrs **2 Atelectasis, one peritoneal bleeding biliopancreatic limb (reop D1), one GJ bleeding (endoscopy + clips), one G staple line disruption (JJ obstruction) reop D5 and four JJ obstructions (all reop)(3/4 mesenteric closure).

Table 2: Results from control and Seamguard groups

Control Seamguard P Value
Gastric loads 3.8 ± 0.7 3.8 ± 0.7
Hemostatic Clips 2.29 ± 2.67 0.2 ± 0.8 p< 0.000001
Duration 84.6 ± 23.1’ 85.6 ± 24.9’
Perop Blood loss 10.5 ± 29.9 ml 3.9 ± 9.4 NS
Drainage D1 81.8 ± 60.8 106.2 ± 62.6
D2 61 ± 67.5 65.8 ± 48
D3 46.8 ± 61.3 73.8 ± 93.5
Total 186.2 ± 169.3 240 ± 158
Drain removal 2.9 ± 0.34 Days (2 drain removed on day 2) 3.05 ± 0.5 (4 drains removed on day 2)
Stay 3.8 ± 1.2 Days 4.6 ± 2.7 J
Hb PRE 14 ± 1.2 13.8 ± 1.4
Hb D1 13.3 ± 1.2 13 ± 1.2
Hb D2 13.6 ± 1.2 13.3 ± 1.6

Conclusions


The Seamguard was easy to use and did not lengthen operative time and significantly decreased the need for additional means of haemostasis (number of clips), said Topart. “There were cases of bleeding on the gastric stapling line itself and two bleedings unrelated to Seamguard. In addition, there were five small bowel obstructions (out of six) directly related to technical changes (mesenteric closure) not related to Seamguard.”


He added that the Seamguard was unfortunately not able to prevent gastric staple line disruption five days post-op after recurrent vomiting. However, four other patients in the Seamguard group with bowel obstruction also had repeated vomiting without staple line disruption. In regards to France, Topart stated that its routine use can hardly be justified despite its effectiveness because of the cost (8 clip load costs €38 and is anyway used as clips mark the bowel length).

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