|Year : 2019 | Volume
| Issue : 3 | Page : 668-674
Evaluation of laparoscopic sleeve gastrectomy with and without staple line reinforcement
Mohammed H Elshafey
Department of General Surgery, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
|Date of Submission||27-Sep-2019|
|Date of Decision||29-Sep-2000|
|Date of Acceptance||17-Nov-2019|
|Date of Web Publication||10-Feb-2020|
Source of Support: None, Conflict of Interest: None
Background Laparoscopic sleeve gastrectomy (LSG) as a primarily restrictive bariatric surgical procedure has been shown to be effective in producing marked weight loss. However, LSG-associated gastric leakage and hemorrhages remain the most important challenges postoperatively. Staple line buttress reinforcement has been suggested to reduce these postoperative complications.
Aim of the study The objective of this study was to evaluate laparoscopic sleeve gastrectomy with and without staple line reinforcement.
Methods Between July 2017 and December 2018. 60 cases were prospectively and randomly enrolled in the two different techniques of handling the staple line during LSG. Group A I(30 patients) with no reinforcement. Group B(30 patients) with reinforcement by over sewing prolyn suture. Operative and postoperative complications were recorded. The study was controlled prospectively.
Results Two patients develop leakage one in each group (3.3%). Two patients developed postoperative hemorrhage in Group A (6.6%), One case developed port site bleeding in Group B (3.3%). One patient developed sub phrenic abscess in group A (3.3%). Three patients readmitted for blood transfusion. Two patients re-operated for diagnostic laparoscopy, port site bleeding in group B (3.3%) and staple line bleeding in group A (3.3%). The differences between the two groups did not reach statistical significance.
Conclusion In this prospective study the final results of leaving the staple line untouched appears to be safe, although the logic of reinforcement is understandable. However, improved results for reinforcement have not been supported by the statistics.
Keywords: laparoscopy, reinforcement, sleeve gastrectomy
|How to cite this article:|
Elshafey MH. Evaluation of laparoscopic sleeve gastrectomy with and without staple line reinforcement. Sci J Al-Azhar Med Fac Girls 2019;3:668-74
|How to cite this URL:|
Elshafey MH. Evaluation of laparoscopic sleeve gastrectomy with and without staple line reinforcement. Sci J Al-Azhar Med Fac Girls [serial online] 2019 [cited 2020 Oct 24];3:668-74. Available from: http://www.sjamf.eg.net/text.asp?2019/3/3/668/278045
| Introduction|| |
The prevalence of morbid obesity is rapidly increasing worldwide. As surgery has been recognized to be the only long-term treatment for morbid obesity, it can be associated with complications .
Obesity is complex and poorly understood, and the components of this disease likely include a combination of environmental and genetic factors, but it includes genetic, behavioral, psychological, and other factors as well .
Laparoscopic sleeve gastrectomy (LSG) is emerging as a new promising therapy for the treatment of morbid obesity. This procedure, originally conceived as a first stage for achieving weight loss in superobese patients before performing gastric bypass (GBP) or biliopancreatic diversion, has revealed to be effective on its own and a potential competitor with these operations. In fact, LSG has the advantage to be less invasive than GBP and biliopancreatic diversion, and not inferior in terms of sustained weight loss, as demonstrated in some preliminary studies .
During LSG, the stomach is resected by repeated stapling, forming a tube-shaped stomach known as a sleeve. Leaks in the long staple line are a major concern. Leak rates have been reported to decrease to 2.5% with increasing experience and the development of new techniques .
LSG is also considered to be a simpler procedure than GBP. However, complications derived from the staple line, such as leaks or bleeding, can be life-threatening. Leaks are the most significant complication and can lead to sepsis, chronic fistula, or even death. The most frequent site is the proximal third of the staple line .
These events are difficult to manage and can lead to prolonged hospitalization. To avoid or minimize leaks, several reinforcement methods have been used to strengthen the staple line, with variable results, and there is no consensus on the best method .
| Patients and methods|| |
The present study included 60 morbidly obese patients (with BMI ≥40 or ≥35 kg/m2 associated with other comorbidities), presented to Al-Azhar University Hospitals, in Cairo, Egypt, for elective LSG, during the period from July 2017 and December 2018, after obtaining the Local Ethics Committee approval. All patients admitted to the Surgery Department signed a written informed consent form. They were randomized using closed-envelope technique into two groups:
- Group A: (30 patients) with no reinforcement of stable line.
- Group B: (30 patients) with reinforcement by oversewing prolene sutures.
We assessed the eligibility of all bariatric patient admitted to our hospital who met the following criteria for bariatric surgery:
- BMI more than 40 kg/m2 or more than 35 kg/m2 with an obesity associated comorbidity.
- Age between 18 and 60 years.
- No endocrinal causes for obesity.
- Psychologically stable patients.
- Sufficient nonsurgical trials to reduce weight.
- Motivation and acceptance of surgical risks.
Exclusion criteria were all patients with the following:
- Psychiatric impairment.
- Those with BMI less than 40 kg/m2 or less than 35 kg/m2 and not associated with other comorbidities.
- Those who had previous abdominal surgery or other contraindications for laparoscopic surgery.
- Younger than 18 years or older than 60 years.
- Pregnant or breast feeding.
- Patients with a history of bariatric surgery.
- Patients with large hiatus hernia or history of gastroesophageal reflux disease.
- Significant long-standing heart/lung disease or other severe systemic disease.
All patients were subjected to full clinical preoperative evaluation (personal and medical) as well as full laboratory investigations (as full blood count, liver function tests, kidney function tests, liver enzymes, thyroid function; T3, T4, thyroid stimulating hormone, and lipid profile).
Clinical evaluation was aimed at assessment of degree of obesity, preoperative evaluation, and detection of different complications of morbid obesity like hypertension, diabetes mellitus, sleep apnea, skeletal problems, infertility, hernias, and history of psychotherapy.
- The patients are consider eligible for LSG if the International Federation for Surgery of Obesity conditions are applicable to them.
- Patients were completely counseled on the procedure, outcome, and possible complications.
- A written consent was obtained.
A patient is placed on the operating table in the supine position with the operating surgeon between the legs of the patient. The preferred position for operating was using the full incline of the table in the anti-Trendelenburg position. However, during the port placement, the patient was placed in the supine position.
A pneumoperitoneum is then established to 15 mmHg pressure carbon dioxide using veress needle inserted at the site for the umbilical port. Optical entry is the preferred method of entry to the abdominal cavity with 12 mm trocar loaded with the 10 mm 0° laparoscope under laparoscopic observation. This laparoscope is then changed to a 30 or 45° scope.
A four 12 mm trocars are passed obliquely through the abdominal wall, including right and left upper quadrant trocars, an epigastric trocar, and a supraumbilical trocar just to the left of the midline, whereas a fifth 5 mm trocar is inserted in the left iliac region.
A nasogastric tube is inserted at the beginning to decompress the stomach. A window is dissected at the junction of the greater curvature and the greater omentum, around 10 cm from the pylorus. Division of the gastroepiploic, short gastric, and posterior fundic vessels is done starting at 4 cm proximal to the pyloric ring all the way till the angle of His using the ultracision harmonic scalpel (Harmonic; Ethicon Endosurgery, Cincinnati, Ohio, USA).
Once the dissection part is over, a 36 Fr bougie is introduced orally by the anesthesiologist through the esophagus and inside the stomach. The surgeon then guides it along the lesser curvature and into the pyloric channel and duodenal bulb.
Gastric transection begins 4–6 cm proximal to the pylorus. A 60 mm, green or gold cartilage, using Ethicon Echelon flex 60 is placed across the antrum through the right midepigastric port and fired. The second stapler is placed ∼1–2 cm from the border of the lesser curvature in the direction of the gastroesophageal junction (GEJ). The bougie must be held in position during this part of the procedure until completion of the stomach transection to avoid stapling across a displaced bougie.
Sequential firings of the stapler along the border of the bougie on the lesser curvature completes the gastric transection at the left crus. After completing the transection, the entire staple line is inspected carefully to ensure that the staples are well formed especially at the antrum where the stomach is the thickest.
The transected part of the stomach is then removed through one of the 12 mm port sites. Then reinforcement by continuous prolene suture (oversewing) was done in group B. After completion of the gastric transection, the integrity of the staple line is tested by injection of methylene blue through bougie gradually and under pressure with the pylorus compressed by a surgical grasper. Methylene blue is injected (via the bougie) into the stomach, and the staple line is inspected carefully to exclude macroscopic leaks of the suture line. The dye is then removed from the stomach, as is the bougie. An 18 Fr Nelaton drain is inserted along the suture line. All trocar sites are closed with 0 Vicryl (Ethicon) sutures using a suture passer to prevent abdominal wall hernias.
Statistical analysis was performed using nonparametric test for comparison. For qualitative data, χ2 or Fisher’s exact probability test (two samples, unpaired) or McNemar test (two samples paired) was used. For the quantitative data, Wilcoxon’s signed rank test (two samples, paired) with correction for ties was used. Two-sided values less than or equal to 0.05 were considered significant.
| Results|| |
The number of cases done was 60 patients divided into two equal groups: group A, with no reinforcement, and group B, with reinforcement. All procedures were completed laparoscopically with no conversion to open surgery. No mortality was recorded.
The age of the study population ranged between 19 and 53 years, with a mean age of 33.7 years. The study comprised 19 (31.6%) males and 41 (68.3%) females with ratio of 1 : 2.1 male : female. The BMI of the study population ranged from 37.7 to 59.5 kg/m2, with a mean BMI of 48.6 kg/m2. The weight of patients ranged from 100 to 150 kg. The height of the patients ranged from 140 to 180 cm.
A total of seven (23.3%) patients in group A and eight (26.6%) patients in group B had diabetes mellitus; five (16.6%) patients in group A and nine (30%) patients in group B had hypertension; and four (13.3%) patients in group A and seven (23.3%) patients in group B had a history of previous surgical operation.
The number of staple cartridges fired and the linearity of the staple line were similar in all patients. The mean operative time to perform LSG was 96±25 min in group A and was 120±35 min in group B.
Overall, two (3.3%) patients had lung atelectasis, which was diagnosed by clinical and radiological signs and resolved with chest physiotherapy. Fever started between the second and third day postoperatively, with no apparent origin in three (5%) patients, ranging from 37.5 to 38.1. It resolved spontaneously with undetected cause. A total of three (5%) patient had skin bruises around the umbilical port and resolved spontaneously within 15 days. Moreover, eight patients (13.3%) experienced mild nausea and vomiting which improved spontaneously and were not so severe ([Figure 1],[Figure 2],[Figure 3],[Figure 4],[Figure 5],[Figure 6],[Figure 7],[Figure 8],[Figure 9],[Figure 10],[Figure 11] and [Table 1],[Table 2],[Table 3],[Table 4],[Table 5],[Table 6]).
|Table 2 Patient’s data regarding diabetes mellitus, hypertension, and previous operation|
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|Table 3 Data of follow-up of patients regarding mean % excess weight loss and BMI changes at 6 month after laparoscopic sleeve gastrectomy|
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Two patients develop leakage (one in each group) and were diagnosed in the first week postoperative by gastrografin and computed tomography abdomen and pelvis with contrast and managed by endoscopic gastric stenting.
Two patients developed postoperative hemorrhage in group A and were managed by conservative treatment. One case developed port site bleeding in group B. One patient developed subphrenic abscess in group A. Three patients were readmitted for blood transfusion. Two patients were reoperated for diagnostic laparoscopy (port site bleeding in one patients in group B and staple line bleeding in the other patient in group A).
| Discussion|| |
LSG is still a new procedure with many technical variations. Sleeve volume, bougie size, stapling technique, distance from pylorus, and reinforcement may affect short-term, medium-term and long-term weight loss and metabolic outcomes. The only technical point beyond controversy and now universally accepted is that an orogastric bougie must be inserted during stapling .
The thickness of different parts of the stomach and their vascularity has not been studied in great detail in the medical literature. Although gastric wall thickness has been reported to vary, it is thick in the antrum (3.1 mm), moderate in the body (2.4 mm), and thin in the fundus (1.7 mm). So the choice of staple height is very important. The longer staple height should be considered for safe and proper closure .
Several studies have shown that reinforcement decreases the risk of bleeding from the staple line , and our results are the same to these studies.
However, the long staple line used in LSG has created particular concerns about the risk of leaks, which has been reported to range from 0.7 to 5.7% .
The leak rate in this study was 3.3% (two leaks in 60 patients). The use of smaller bougies to augment weight loss and close stapler approximation around the incisura angularis produced functional obstruction, in addition to the natural physiologic obstructive mechanism of the pylorus. Creating a long, tight sleeve leads to increased intraluminal pressure, which may overcome staple line strength and cause leaks. To avoid leaks, most surgeons prefer to reinforce the staple line during LSG, mostly by suturing or using buttressing materials, whereas some surgeons leave the staple line untouched .
Most bariatric surgeons would, however, regard the development of a leak as the worst complication after LSG, as it is associated with increased morbidity and it is often difficult to treat, requiring multiple endoscopic and/or surgical interventions. Approximately 90% of leaks appear near the GEJ .
The etiology of leaks is poorly understood. However, mechanical, tissue, and ischemic factors may play a role .
A high intraluminal pressure owing to the intact pylorus and/or antrum may also contribute and lead to delayed healing. This study shows no difference between reinforcement or not of suture line, although more prolonged time of operation with reinforcement, which is nearly the same as other studies.
There are three randomized studies comparing different reinforcement techniques in LSG. The only randomized controlled study comparing the outcome in three groups (no reinforcement, buttressing with Gore Seamguard, and staple line suturing with polydiaxone) was published by Dapri et al. .
In this study, surgery was longest in the group where the staple line was over-sutured whereas blood loss was significantly lower in the group in whom buttressing with Seamguard was used.
In another study where patients were randomized between buttressing of the last staple firing at the GEJ with Seamguard (48 patients) versus suturing of the whole length of the staple line with PDS 2.0 (42 patients), no significant difference between bleeding and leak rates were found .
In another study, Gentileschi et al.  also found no significant differences when 120 patients were randomized to LSG with oversewing versus buttressed transection with a polyglycolide acid and trimethylene carbonate versus staple line roofing with a gelatin fibrin matrix.
Stapler-related problems or tissue ischemia may lead to impaired tissue healing and dehiscence of the staple line if higher intraluminal pressures are reached .
Leaks owing to ischemia usually occur around postoperative days 5–7, when the healing is between the inflammatory and fibrotic phases, whereas most leaks occur in the first 48 h, which suggests an additional mechanical cause. There are insufficient data about the causative factors in leaks to support the rationale for the use of reinforcements .
LSG animal studies have demonstrated increased lactic acid levels along the GEJ, which indicate a predisposition toward tissue ischemia. However, a significant difference could not be verified .
Experiments on reinforcing the staple lines to avoid leaks have provided variable results, and it is not clear whether the buttressing materials provide any benefit in preventing ischemia. We are aware that the studied groups were small, a potential cause of bias. A larger number of patients would have produced stronger support for the claim that leaks may be unavoidable, even with reinforcement, but we should emphasize that the leak rate after LSG has been decreasing as experience with the technique has increased. Most surgeons prefer to use reinforcement along the staple line, and some have described proper technique and suitable stapler sizes .
Summary and conclusion
Bariatric surgery is an expanding and continuously evolving specialty aiming at combating the obesity epidemic through offering long-term sustained weight loss. The life cost of obesity and its comorbidities is huge, and bariatric surgery has proven to cut these costs, proving to have not only healthcare benefit to the obese patients but also a great benefit to the financial burden.
Several restrictive procedures have been implied by surgeons all over the world, where, recently, LSG has been gaining popularity over the other procedures.
In our pilot study, we present experience with LSG on a substantially voluminous number of patients and stress the fact that over-sewing is not necessary while performing this surgical procedure. Not only our approach brings economical benefit by shortening the time of surgery roughly by 10 min (personal observation) but also decreases the time of anesthesia, and last but not the least, it excludes the possibility of too much narrowing of the tubulized stomach. LSG is considered an effective and safe bariatric procedure, with low incidence of complications and loss outcome. Nevertheless, more long-term studies are necessary to confirm its benefit also for the long-term treatment of morbid obesity.
We concluded that leaving the staple line untouched appears to be safe, although the logic of reinforcement is understandable. However, improved results for reinforcement have not been supported by the statistics.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]