Staple Line Reinforcement with Stitch in Laparoscopic Sleeve Gastrectomies. Is It Useful or Harmful?

Abstract

Background:

Reinforcement of the staple line in laparoscopic sleeve gastrectomy (LSG) is a practice that leads to less morbidity, but equivocal results have been reported in the literature.

Materials and Methods:

This is a prospective randomized study comparing two groups of patients who underwent LSG. In one group LSG was performed with a running absorbable suture placement at the staple line. In the other group the running suture was not placed. General data of the patients, as well as intraoperative and postoperative data, were gathered and statistically analyzed.

Results:

Overall, 146 patients were subjected to LSG. In 84 patients a running suture was placed, and in 62 patients no suture was placed. No significant differences were found between the two groups in demographic data. No significant differences were found also in the intraoperative data, such as number of trocars, number and type of cartridges, drain placement, and operative time (45±21 versus 40±20 minutes, respectively; P<.05). Intraoperative complications were significantly more in the group with the suture placement (33.3% versus 16.1%, respectively; P<.05). Hematomas developed intraoperatively in more patients after the placement of the running suture (9.5% versus 0.0%, respectively; P<.05). Postoperatively, there was no significant difference in morbidity between the two groups (8.3% versus 9.7%, respectively; P>.05).

Conclusions:

After this randomized study, final conclusions about the efficacy of this running suture to the staple line cannot be made. To the contrary, problems seem to exist after such reinforcement of the staple line, such as hematomas. Dealing with possible leaks and hemorrhage of the staple line is also problematic after placement of the running suture.

Introduction

Great results over the years and simple methodology have made laparoscopic sleeve gastrectomy (LSG) a valid option for morbidly obese patients. Today sleeve gastrectomy is a stand-alone bariatric procedure with comparable results with other well-established bariatric procedures, such as gastric bypass and biliopancreatic diversion.^1–4

The major drawback of this procedure is mainly the severity of the postoperative complications. The major complications of LSG are leak from the staple line and hemorrhage from the staple line, the spleen, and the small gastric vessels. Staple line leaks are the most dangerous complications and can prove life-threatening. The incidence of leak from the staple line after LSG in centers of excellence is less than 1%.^3,4 The site with the most chances for leakage is positioned near the gastroesophageal junction, unless stapler malfunction occurs. Management of this complication is rather difficult, with a long hospital stay and demanding surgical and/or endoscopic treatment with stent placement.^4–6 Bleeding from the staple line is the most common complication. Significant bleeding exists in 1.6%–10% of cases, and it is one common reason for re-operation in the postoperative period.^6,7

Several practices exist in order to eliminate both of these complications. In most of the cases, oversewing the staple line or buttressing it with several agents, such as specific bioabsorbable material, bovine pericardium, or porcine small bowel, has failed to provide clear benefit.^8–11 In this study an experienced bariatric team assessed the safety and efficacy of the reinforcement of the staple line with a running absorbable suture after LSG in 146 patients.

Materials and Methods

This prospective randomized study was conducted in a bariatric center, from the experience of a single bariatric surgeon. The bariatric team is a well-experienced surgical team with more than 400 sleeve gastrectomies performed during the last 4 years. This study was approved by the local ethical committee, and informed consent was obtained from all patients before operation.

Between December 2012 and December 2013, 146 consecutive patients were enrolled in this prospective randomized study. All patients were eligible for LSG and fulfilled the criteria for surgical treatment of morbid obesity. There were no exclusion criteria to enter this trial. These patients were randomized into two groups using computer-generated random numbers. The randomization of the patients was performed after their first visit at the clinic. Before the operation the patients consented to participate to the study. In the first group (Group A) patients underwent LSG without any reinforcement of the staple line. In the second group (Group B) patients underwent LSG with oversewing of the entire staple line with a continuous suture. The same protocols were followed for anesthesia and postoperative management for the patients of both groups.

The bariatric surgical team gathered preoperative, intraoperative, and postoperative data. Preoperative and intraoperative data were gender, age, weight, height, body mass index, previous operations, demographic data, operative time, and numbers of trocars and cartridges. Intraoperative complications, hospital stay, 30-day postoperative complications, and treatment of complications were also recorded and analyzed.

Operative technique

The patient was positioned in the supine position, with the legs apart, in a slightly reverse Trendelenburg position. Pneumoperitoneum was established with the open technique, and four trocars were placed (midline above umbilicus a 10-mm trocar for the camera, at the right midclavicular line a 12-mm trocar for the linear stapler, at the left midclavicular line a 10-mm working or retracting trocar, and at the left midaxillary line a 5- or 10-mm working or retracting trocar). A grasper was used for retraction of the liver, and in cases with a large liver, a liver retractor was used. The greater omentum was freed from the greater curvature of the stomach from a point 3–4 cm above the pylorus through the angle of His. This maneuver was accomplished with the aid of a laparoscopic shears using ultrasonic vibration. A bougie (34 French most of the time) was placed to guide the gastric section. The vertical sectioning of the stomach was performed with two firings of a laparoscopic linear stapler with thick tissue loads (4.1 mm) and subsequently firings with regular tissue loads (3.5 mm). All the firings were performed in close proximity to the bougie.

In the second group a full-thickness running suture was placed from the angle of His to the end of the staple line, near the pylorus. The suture that was placed was an absorbable suture (polydioxanone [PDS] 0). This suture was passed through below the staple line at approximately 3–5 mm from both sides of the staples and pulled slightly after each bite. This suture line was placed with 1-cm intervals. The goal of this sparsely placed suture was to strengthen the entire staple line. At the end of the staple line, near the pylorus, the edge of the suture was fixed with a clip or a knot. After the suture placement methylene blue was instilled inside the stomach remnant through the nasogastric tube to investigate possible leakage. A drain was placed when the surgeon thought it was appropriate, mainly in cases of hemorrhage or suspicion of leak. The portion of stomach to be removed was extracted from an enlarged trocar site. The nasogastric tube was left in place for 24 hours postoperatively.

Statistical analysis

Ad hoc power analysis showed that in order to detect two-sided significant differences greater than 25% in our main variable of interest (percentage of intraoperative complications), 47 patients should be enrolled in the study in each group in order to obtain a statistical power of 70% at a significance lever of P<.05. We exceeded the desirable number in order to obtain the highest statistical power possible. All continuous variables were tested for normal distribution using the Kolmogorov–Smirnov test for normality. Because the majority of the variables had a non-normal distribution, the median and interquartile range (75th–25th percentile) were used as descriptive statistics, and the Mann–Whitney U test was used for comparison between the two categories of a categorical variable. Pearson's chi-squared test and Fisher's exact statistics were used in order to evaluate any association between pairs of categorical variables. The latter were described as absolute (N) and relative (%) frequencies. All tests were two-sided and considered significant if the P value was <.05. IBM^® (Armonk, NY) SPSS^® version 22 software was used for the statistical analysis.

Results

During the study period, 62 patients underwent LSG for morbid obesity without a running suture at the staple line (Group A), and in 84 patients a suture was placed as previously described (Group B). Post hoc power analysis calculated the statistical power of our results at 60.4%. Overall, 34.7% of the patients were men, and 65.3% were women. Their median age was 36.0±15.0 years. Of the patients, 20.9% had undergone previous abdominal operations, open and/or laparoscopic. The mean operative time for the LSG was 43.0±18.0 minutes, and four trocars were used in all patients. The mean hospital stay was 4.0±2.0 days. Preoperative general data and intraoperative data of patients of Groups A and B are shown in Table 1.

Table 1.

General Characteristics and Intraoperative Data of Patients Who Underwent Laparoscopic Sleeve Gastrectomy With (Group B) and Without (Group A) a Running Suture

	Group A (no running suture)	Group B (running suture)	P value
Patients	62	84
Sex			.254
Male	18 (29.0%)	32 (38.1%)
Female	44 (71.0%)	52 (61.9%)
Age (years)	36.0±17.0	38.0±13.0	.330
BMI (kg/m²)	45.65±6.6	46.90±7.6	.736
ASA score	2.3±1.2	2.2±1.3	.410
Previous abdominal operations	13 (20.9%)	16 (19.1%)	.445
Conversion	0 (0.00%)	0 (0.00%)
Operative time (minutes)	40±20	45±21	.139
Trocars	4±0.00	4±0.00	.195
Cartridges
Green (4.1 mm)	2±0.00	2±0.00	.663
Blue (3.5 mm)	4±1.00	4±1.00	.882
Drain	8 (12.9%)	18 (21.4%)	.183
Hospital stay (days)	3.5±2.0	4.0±3.75	.827

Data are median±SD values or number (percentage) as indicated.

ASA, American Society of Anesthesiologists; BMI, body mass index.

There were no significant differences in demographic and intraoperative data between the two groups. The two groups were homogeneous for age, sex ratio, body mass index, American Society of Anesthesiologists score, and previous abdominal operations. Operative time was increased in Group B, but this difference was not significant (40±20 minutes versus 45±21 minutes; P<.05). The surgical team did not have to convert to the open procedure in any of the 146 LSG procedures. Drains were placed in 8 patients of Group A and 18 patients of Group B (12.9% versus 21.4%, respectively; P<.05).

The intraoperative and postoperative complications (30 days postoperatively) are shown in Table 2. Also given in Table 2 are the methods the surgical team used to deal with the intraoperative and postoperative complications. Intraoperatively, the complication rate in Group A was 16.1%, and that in Group B was 33.3%. This difference was significant between the two groups (P=.019). Specifically, the placement of the running suture caused hemorrhage in 17 patients, hematoma in 8, and adjacent organ injury in 3, and a leak was implicated in 2 patients. These leaks were identified intraoperatively and dealt with during the same operation. In 10 patients of Group A hemorrhage from the staple line was observed. The ways the surgical team dealt with these complications were single stitches in 4 patients, clip placement in 5 patients, and in 1 patient an absorbable hemostat. In Group B additional single sutures were placed in 12 patients. Finally, in 5 patients of Group B the team used an absorbable hemostat, and in 2 patients coagulation was used.

Table 2.

Intraoperative and Postoperative Complications of Patients Who Underwent Laparoscopic Sleeve Gastrectomy With (Group B) and Without (Group A) a Running Suture of the Staple Line and Ways of Dealing with Them

	Group A (no running suture)	Group B (running suture)	P value
Intraoperative complications	10 (16.1%)	28 (33.3%)	.019^a
Hemorrhage	10 (16.1%)	17 (20.2%)	.527
Hematoma	0 (0.00%)	8 (9.50%)	.021
Leak	0 (0.00%)	2 (2.40%)	.508
Organ injury	0 (0.00%)	3 (3.60%)	.262
Dealing with intraoperative complications	10 (100%)	19 (70.4%)	.079
Stitch	4 (40.0%)	12 (44.4%)	.999
Clips	5 (50.0%)	0 (0.00%)	.001^a
Absorbable hemostat	1 (10.0%)	5 (18.5%)	.999
Coagulation	0 (0.00%)	2 (7.40%)	.999
Postoperative complications	6 (9.70%)	7 (8.30%)	.778
Hematoma	0 (0.00%)	0 (0.00%)
Hemorrhage	1 (1.60%)	2 (2.40%)	.999
Abscess	2 (3.20%)	1 (1.20%)	.575
Collection	0 (0.00%)	2 (2.40%)	.508
Leak	0 (0.00%)	0 (0.00%)	—
Fever (temperature >38°C)	2 (3.20%)	2 (2.40%)	.999
Gastroesophageal area narrowing	1 (1.60%)	0 (0.00%)	.425
Dealing with postoperative complications	6 (100%)	7 (100%)
Conservative	5 (83.3%)	5 (71.4%)	.999
Surgery	0 (0.00%)	2 (28.6%)	.462
Endoscopic	1 (16.7%)	0 (0.00%)	.569
Mortality	0 (0.00%)	0 (0.00%)	—

Data are number (%).

Significant difference.

Postoperatively, the 30-day morbidity of Groups A and B did not significantly differ (9.7% versus 8.3%, respectively; P>.05). In both groups hemorrhage, abscesses, and fever were present. Two patients in Group B needed re-operation due to hemorrhage and abscess formation. In 1 patient in Group A narrowing of the gastroesophageal region was recorded in an upper gastrointestinal series with a water-soluble contrast. Endoscopic stent placement in this case was sufficient with remission of symptoms. No signs of leak and no deaths in both groups occurred during the 30-day interval after LSG.

Discussion

Bariatric surgery is the best approach to sustainable weight loss, improving overall survival and comorbidities, such as diabetes mellitus, hypertension, and sleep apnea, in morbidly obese patients.¹² Sleeve gastrectomy was first described approximately 10 years before, as the first step of a staged operation.^13,14 This operation is considered now a promising stand-alone operation and the first-line solution in the worldwide obesity epidemic. LSG is now an eligible alternative to laparoscopic gastric bypass.^{1–3,15–18}

Among the various complications of LSG, hemorrhage and staple line leak are the most feared.^3,15,16 Mechanical problems could occur, and most of the times these could result in a leak. Ischemia is one of the theories for the development of leakage in the gastroesophageal area.¹⁹ Newer studies after measuring with microdialysis levels of lactic acid, glycerol, and pyruvate concluded that ischemia in this region is not the basic pathophysiologic mechanism.²⁰ Natoudi et al.²⁰ thought that, eventually, leakage could be correlated with mechanical problems and could parallel the high intraluminal pressure that developed in the long tubulized gastric reservoir.

Surely, increased experience and more reliable and qualitative laparoscopic staplers and shears helped. Furthermore, there were many attempts from many obesity surgery centers to reduce morbidity and especially these two complications with reinforcement of the staple line. Various methods and materials have been proposed for the reinforcement of the staple line, such as polyglycolic acid-trimethylene carbonate (Gore^® Seamguard^®; W.L. Gore & Co., Newark, DE), bovine pericardium (Peri-Strips Dry^®; Baxter Healthcare Corp., Deerfield, IL), porcine small bowel (Surgisis^®; Cook Biotech, Inc., West Lafayette, IN), expanded polytetrafluoroethylene, fibrin glue sealants, and oversewing.^{6,8,13,15,21–29} To date, there is no high-grade evidence in the literature about the need for staple line reinforcement with materials during LSG. Nevertheless, this is a practice that is highly recommended by many bariatric centers, but it is still a questionable and debatable issue.^6,8–11

In this study the surgical team tried to investigate the safety and efficacy of a continuous suture that was placed from one end to the other of the staple line. The suture that was used in this study was an absorbable PDS 0 stitch that placed through all the stomach wall layers. This a totally different technique from the ones described in other studies, in which the staple line is reinforced after LSG. Other authors described a running seromuscular absorbable suture (PDS 2-0 or polyglyconate [Maxon™; Covidien, Norwalk, CT] 2-0 or 3-0); in these studies oversewing with this technique seems to diminish the staple line leak rate but does not eliminate it completely.^13,16,30 The decision to perform this maneuver was taken thinking that the bigger running suture passing behind the staple line would not just invert the staple line, but should protect as the tension would be fully absorbed. The bigger suture would also inserted in larger spaces, and this fact should not affect as much the blood perfusion of the staple line as the individually placed 2-0 or 3-0 sutures. Passing below the staple line from all layers could not possibly be performed with a smaller-sized stitch.

The randomization of the patients helped the team to overcome any bias. The randomization of the patients was performed after their first visit at the clinic. Before the operation some of the patients did not consent to participate to the study. This is the reason why there is a relatively big deviation in numbers of patients per group. Eventually this study was not fully completed with the initially planned number of patients. Preliminary statistical analysis of the collected data revealed that the running suture produced more hemorrhage and hematomas intraoperatively. So the collection of patients stopped because the numbers of patients in each group were sufficient to prove the results.

Intraoperatively, in Group B there were significantly more hematomas than in Group A (P=.021). This significant difference is the result of the running absorbable suture that was placed in these patients. There is also a trend for hemorrhage in more patients and organ injuries in this group, but these indications proved to be not significant. The needle for the stitch was responsible for 3 cases of injuries at the liver, and in 2 of these cases coagulation was sufficient. The greater number of hematomas resulted in a feeling of insecurity among members of the surgical team, and this caused more drain placements in this group (21.4% versus 12.9%, respectively; P>.05) and prolonged hospital stay, differences that eventually were not significant. Moreover, dealing with the intraoperative complications was also not the same. It was very difficult in the patients in whom the running suture was placed to use clips to stop regional bleeding. In this group an additional stitch was the most feasible means to stop the hemorrhage or the leak. In Group A clips were easy to place at the staple line if a small amount of bleeding was present (50% versus 0.00%, respectively; P<.05). Nevertheless, the suture placement did not prove to be a time-consuming procedure for this experienced team and did not affect significantly the operation time (40±20 minutes versus 45±21 minutes, respectively; P>.05).

In the postoperative period, the first 30 days after the operation, there were no significant differences between the two study groups. Overt leaks of the staple line did not present in both groups. Nevertheless, 2 patients in Group A and 1 patient in Group B developed abscess near the gastroesophageal area. We suspect a small leak in this area in these patients, but computed tomography with oral contrast and an upper gastrointestinal series did not reveal any overt leak. Also, no significant differences between these two groups occurred for postoperative hemorrhage. Only 1 patient in Group A developed narrowing of the gastroesophageal area, a complication for which the running suture seems not to be responsible in this study. The endoscopic treatment with dilation of the stricture revealed the problem and the symptoms of the patient. The team also tries not to place the staple line very close to the esophagus.

After this prospective randomized study we cannot make any final conclusions about the efficacy of this running suture at the staple line in view of the relatively small sample size and the nonsatisfactory statistical power. To the contrary, problems can exist after this reinforcement, such as hematomas. These problems seem to stem from the greater size of the needle and the stitch, and passing it below the staple line from all stomach wall layers produced greater hemorrhage. Dealing with possible leaks and hemorrhage of the staple line has proved also to be problematic after the placement of this running suture.

Footnotes

Disclosure Statement

No competing financial interests exist.

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