|Year : 2020 | Volume
| Issue : 4 | Page : 1328-1334
Imbrication versus no reinforcement during laparoscopic sleeve gastrectomy
Hatem M Sultan1, Abd-Elgalil M El-Balshy1, Osama M. M. Moustafa2
1 Department of General Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Surgery, Abou Kir General Hospital, Alexandria, Egypt
|Date of Submission||01-Jun-2020|
|Date of Decision||12-Jul-2020|
|Date of Acceptance||17-Jul-2020|
|Date of Web Publication||24-Dec-2020|
Osama M. M. Moustafa
9 Bakous Alexandria, Beside Tawhid Mousque, Alexandria
Source of Support: None, Conflict of Interest: None
Laparoscopic sleeve gastrectomy (LSG) is a common procedure in recent years for treatment of morbid obesity. However, leak and bleeding are its main challenging complications. Despite numerous studies regarding such complications, there is still no conclusion on reinforcement of staple line in this procedure. The purpose of our study was to compare staple line imbrication versus no reinforcement.
To determine the effects of reinforcement of staple line by imbrication using continuous seromuscular invagination using absorbable suture on bleeding, leakage, length of hospital stay, readmission, reoperation rates, and stricture rates.
Patients and methods
In our pilot study, 60 patients experiencing morbid obesity with BMI above 35 kg/m2 were prepared for LSG. The patients were enrolled randomly into two equal groups comparing the effect of staple line reinforcement by imbrication whole staple line by seromuscular invagination using absorbable suture (group A) versus no reinforcement (group B). The study was conducted in Menoufia University in the period between October 2017 and June 2019.
Hemorrhage and leak did not occur in group A but occurred in two (6.7%) patients and one (3.3%) patient, respectively, in group B, but stricture occurred in two (6.7%) patients in group A and no patients in group B.
This pilot study has shown that reinforcement by staple line imbrication as a step in LSG is safe, technically easy, of low cost, and can reduce the incidence of postoperative complications, as bleeding and leakage, although it significantly prolongs the operative time and may lead to increase in the rate of stricture.
Keywords: laparoscopic sleeve gastrectomy, reinforcement, staple line bleeding, staple line imbrication, stricture
|How to cite this article:|
Sultan HM, El-Balshy AEM, Moustafa OM. Imbrication versus no reinforcement during laparoscopic sleeve gastrectomy. Menoufia Med J 2020;33:1328-34
|How to cite this URL:|
Sultan HM, El-Balshy AEM, Moustafa OM. Imbrication versus no reinforcement during laparoscopic sleeve gastrectomy. Menoufia Med J [serial online] 2020 [cited 2021 Apr 19];33:1328-34. Available from: http://www.mmj.eg.net/text.asp?2020/33/4/1328/304485
| Introduction|| |
Laparoscopic sleeve gastrectomy (LSG) is one of the most popular bariatric procedures. It is relatively simple and effective in terms of excess weight loss. Factors contributing to the popularity of LSG include technical feasibility, preservation of normal anatomy and absorptive capacity of the intestine, no foreign bodies being implanted, and fewer risks of nutritional deficiencies.
However, it is associated with serious staple line complications, such as bleeding, leaks, and stenosis, which persist despite advances in the technology of surgical stapling devices.
Despite the wide steps in the development of surgical staplers, staple line complications are common, clinically demanding, cost expensive for the patient, and can produce significant morbidity and mortality rates.
The staple line leak and bleeding are the most serious complications with an incidence reported up to 2–5% and 1–6%, respectively.
Our primary end point of this study was occurrence of major complications after LSG, namely, leak and bleeding. Bleeding was defined in terms of clinical signs such as tachycardia, postural hypotension, syncope, and hemorrhagic shock, a postoperative drop in hemoglobin level to less than 10 g/dl, requirement of blood transfusion, and requirement of reoperation to control bleeding.
Leak was defined in terms of clinical signs as persistent fever, tachycardia, dyspnea, persistent abdominal and left shoulder pain, radiographic evidence (extravasation of the oral contrast or intra-abdominal abscess), requirement of radiology-guided drainage of intra-abdominal abscess, and requirement of reoperation to manage the leak.
These serious complications include bleeding and leakage. Hence, adopting special surgical techniques that can lead to a reduction of the incidence of these complications is now of great interest to surgeons. At present, there are several techniques for reinforcing gastric staple lines. Surgeons can over-sew the staple line with suturing technique or buttress using either synthetic or biologic tissue-buttressing materials.
However, some surgeons do not prefer to reinforce staple lines anymore owing to either the cost benefit or lack of clear published data about the benefits of these techniques. Therefore, most extensive data are needed to clearly determine if staple line reinforcement is beneficial or not.
The aim of this study was to determine the effects of reinforcement of staple line by imbrication using continuous seromuscular invagination using absorbable suture on bleeding, leakage, length of hospital stay, readmission, reoperation rates, and stricture rates.
| Patients and methods|| |
Our pilot study was conducted in the Department of Surgery in Menoufia Hospital University, Egypt. The study protocol was approved by the ethical committee of Menoufia medical school. An informed written consent was obtained from each participant, We conducted our pilot prospective study on 60 patients undergoing LSG who were randomly allocated into 30 patients in each group. Randomization was done by using closed envelope technique. The envelopes were opened immediately before induction by a physician who was unaware of the study protocol and responsible for preparing the study design.
All patients' characteristics such as mean age, weight, and BMI and comorbid conditions were assessed for inclusion and exclusion criteria. All patients provided informed consent upon the admission by medical team with full clarification of the surgery steps and signed a written consent before the operation. All the operative details such as operation time and intraoperative and postoperative adverse events including bleeding, technical mistakes, or any intraoperative mishaps were recorded. Moreover, during hospital stay, bleeding and leakage were recorded. After discharge, the patient was scheduled for follow-up weekly for 6 months for assessment of sequelae of the operation, complications like stricture, and occurrence of readmission or reoperation. The aim was to determine the effects of the whole staple line imbrication using absorbable suture on bleeding, leakage length of hospital stay, readmission, reoperation rates, and stricture rates. In group A, the entire staple line was reinforced with continuous suturing (invagination of the whole staple line) of seromuscular layer using '3/0 PDS' absorbable sutures, and in group B, no reinforcement was used.
The following were the inclusion criteria: age from 18 to 65 years; BMI 40–55 kg/m2 or BMI 35–39.9 kg/m2 with comorbid conditions; history of at least 6 months of documented failure with traditional nonsurgical weight loss methods; and female in childbearing willing to accept the usage of an appropriate contraceptive method for 1 year after surgery to avoid nutritional deficiencies during pregnancy.
The following were the exclusion criteria: age less than 18 years or greater than 65 years; previous bariatric or gastric surgery; uncontrolled severe psychiatric illness; and current drug or alcohol abuse.
All patients were subjected to preoperative workup, including history taking [stop smoking and ketogenic diet (1 week–2 months)]; preoperative BMI; respiratory function tests; ECG; routine laboratory tests, such as complete blood count, urea, creatinine, SGOT, SGPT, lipid profile, thyroid hormone, and serum ferritin; and abdominal ultrasound. Informed consent was taken from all the patients. Venous prophylaxis was done by enoxaparin 40 mg given 12 h before surgery and continued for 5 days after surgery.
The patients underwent LSG under general anesthesia in supine position and then in anti-Trendelenburg's position after insertion of trocars. A camera port (12 mm) trocar was used about 6 inches from xiphoid process, slightly to the left of midline of the patient. The other 12-mm port was used on the left midclavicular line about 4 inches from the camera port, and 5-mm trocars were used in the subxiphoid for liver retractor. Another 5-mm trocar was used in the left anterior axillary to the assistant and to be the site of a drain, and a 5-mm trocar was used in the right midclavicular about 4 inches from camera port. Then, we created pneumoperitoneum usually 15 mm pressure. Then, we began to dissect the greater curvature of the stomach to be fully mobilized from ~2–4 cm proximal to the pylorus and preceded to the left crus with dissection of the gastrohepatic fat pad utilizing either the Harmonic scalpel or the ENSEAL (Ethicon Endosurgery, Cincinnati, Ohio, USA). Resection of the stomach was initiated between 2and 4 cm proximal to the pylorus depending on the thickness of the antrum utilized (60-mm linear stapler).
Staple height was dependent on the thickness of the tissue being resected, with a closed height of 2.0–2.3 mm (green or black reloads) for the antrum and body, and 1.8 mm (gold reload) for the funds when tissue thickness was decreased. A 36-Fr bogie was used to size the sleeve, and attempts were made to avoid narrowing of the incisura angularis or stapling of the esophagus. All identified hiatal hernias were repaired. Staple lines of the imbrication group patients were imbricated utilizing a running seromuscular stitch of '3/0 PDS' absorbable sutures (group A). The rest of the cases persist with no reinforcement (group B) [Figure 1]a and [Figure 1]b.
|Figure 1: (a) Beginning of imbrication process after creation of sleeve pouch. (b) Completion of imbrication process of the sleeve pouch.|
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Methylene blue leak test was routinely done. Routine elevation of systolic blood pressure to 140 mmHg was done. Gastrectomy specimen is removed by enlarging the 12 mm port in the left upper abdomen. A drain is placed in the perigastric region. Operational details including mean operative time and intraoperative mishaps (bleeding, organ injuries, conversion, intraoperative leakage) were recorded. Postoperative care included evaluation of the outcome of using staple line imbrication as a method of reinforcement during LSG in preventing staple line bleeding and leak. The effects on operation time, length of stay, readmission, reoperation, and stricture rates within the first 6 months postoperatively were analyzed. The patients were followed up during hospital stay and then weekly after discharge from the hospital for 6 months for detection of early postoperative complication and late ones.
Data were fed to the computer and analyzed using IBM SPSS software package, version 20.0. (IBM Corp., Armonk, New York, USA). Qualitative data were described using numbers and percent. Quantitative data were described using range (minimum and maximum), mean, SD, and median. The significance of the obtained results was judged at the 5% level.
The used tests were as follows:
χ2 test was used for categorical variables, to compare between different groups. Fisher's exact test was used for correction for2 when more than 20% of the cells have expected count less than 5.
Student t test was used for normally distributed quantitative variables to compare between two studied groups.
Mann–Whitney test was used for abnormally distributed quantitative variables to compare between two studied groups.
The sample size should depend on the research context, including the researcher's objectives and proposed analyses.
The following formula was used to calculate the required sample size in this study;
Where n is the sample size, Z is the statistic corresponding to level of confidence, P is expected prevalence, and d is precision (corresponding to effect size). The level of confidence was 95%. By using this equation, the sample size was 30 cases in each group (i.e., 60 cases in the two groups).
| Results|| |
This study was conducted on 60 cases divided equally into two groups: group A included 30 patient staple-line reinforcement (SLR) and group B included 30 patients with no reinforcement non staple-line reinforcement (NSLR). There was insignificant difference between both groups regarding age and sex. Bleeding occurred in two (6.7%) patients in group B. One of them developed increase drain output and hypotension 8 h after surgery. Hemoglobin level was 10 g/dl. Re-laparoscopy for suctioning of the blood and blood clot in peritoneal cavity was performed. A spurting vessel in the staple line was clipped, and hemostasis was achieved. The patient recovered and discharged on third postoperative day. The other case was vitally stable in spite of bloody drain output of about 300 ml. After 6 h postoperatively, hemoglobin level was more than 10 g/dl. The case received conservative management (intravenous fluids, antibiotics, blood transfusion) and improved and got well without needing to re-laparoscopy. Hemorrhage did not occur in group A. One (3.3%) patient of group B presented with abdominal pain, fever, left shoulder pain, dyspnea, and leukocytosis. On the fifth day postoperatively, computed tomography abdomen with contrast was done and revealed a proximal leak as well as perisplenic and perigastric collection. The patient required endoscopic stenting using a self-expanded stent placed at the level of gastroesophageal junction with good response within 1 month and was successfully removed off the stent. No leaks were detected in patients in group A. Two patients in group A (6.7%) experienced frequent vomiting of solid food intolerance after 8 weeks of operation. The upper gastrointestinal tract endoscopy was done and revealed kinking at the incisura angularis, and the scope passed with difficulties. Endoscopic balloon dilatation was done, and the patient became well. No structures were detected in patients in group B. Hemorrhage and leak did not occur in group A, but occurred in 6.7 and 3.3%, respectively, in group B. Stricture occurred in group A in 6.7% of patients and no patients had stricture in group B, but overall, there was insignificant difference between both groups regarding complications [Table 1].
|Table 1: Comparison between the two studied groups according to different parameters|
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Regarding BMI, we found that BMI decreased in both groups after 1 and 6 months, but differences between both groups were insignificant. The operative time was longer in group A, with significant difference in comparison with group B, but regarding the hospital stay, there was an insignificant difference between both groups [Table 2]. Readmission happened in two patients in group A and one patient in group B, and one patient was reoperated in group B [Table 3].
|Table 2: Comparison between the two studied groups according to operation time and hospital stay|
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|Table 3: Comparison between the two studied groups according to readmission and operation|
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| Discussion|| |
LSG was initially used as first step of a staged operation of superobese and/or high-risk patients. Subsequent reports suggested that LSG could be a promising stand-alone operation for treatment of morbid obesity [9–11]. Among the various complications of LSG, staple line leak is the most dreaded one. Owing to the long staple line in LSG, there is a propensity for leak, especially near the gastroesophageal junction.
Depending on the etiology, leaks are classified into two types: mechanical and ischemic. Mechanical leaks usually appear within 48–72 h after surgery and are mainly due to technical errors, inappropriate staple size, and iatrogenic injury, and distal obstruction leaks that appear after 5 days of surgery are likely owing to ischemia.
Bleeding is another major complication in LSG. Bleeding usually occurs from the staple line but may also happen from the resected greater omentum. Another uncommon but expected complication after LSG is postoperative stricture formation.
In the current study, we aimed to determine the effects of reinforcement of staple line by imbrication using continuous seromuscular invagination sutures of the whole staple line on bleeding, leakage, length of hospital stay, readmission, reoperation rates, and stricture rates.
In the current study, 60 cases were divided into two groups with insignificant differences between groups A and group B regarding age and sex. In the study by Dapri and colleagues, 75 patients were prospectively and randomly enrolled, with insignificant differences regarding demographic data. They were divided into three group: no staple line reinforcement (group 1), buttressing of staple line (group 2) staple line suturing (group 3). They reveal no significance difference in the postoperative leak among the three groups, with decreased operative time in group 1 with no staple line reinforcement, and reduce the bleeding and overall blood loss during stomach resection in group 2.
In agreement with our result, Hany and Ibrahim showed that 920 patients were enrolled into A and B groups for each 460 patients. In group A, the entire staple line was invaginated with continuous seromuscular suturing using barbed suture and group B no reinforcement was done.
The demographic characteristics were comparable in both groups. Operative times were significantly longer in group A. Leak was significantly lower in group A with no leak (0 cases) and eight (1.7%) cases had leak in group B, and two (0.4%) cases of bleeding were seen in group A and seven (1.5%) cases of bleeding in group B, with significant difference between both groups regarding bleeding.
In our study, we found that hemorrhage and did not occur in group A, but in group B, two (6.7%) patients had hemorrhage and one (3.3%) patient had leak. Stricture occurred in two (6.7%) patients in group A and no patients had stricture in group B. There were insignificant differences between group A and group B regarding complications.
Gayrel et al. conducted their study on 202 patients, where 116 of them underwent NSLR and 86 with buttressing of the staple line. There was difference with our results, as they showed that regarding complications, staple line leaks were similar in both groups. Bleeding presented significant differences between the two groups. There was no bleeding in the buttressing group, whereas 10 bleeding cases were observed in the control group. There were two (2.3%) cases of gastric leaks in the buttressing group and four (3.5%) in the control group.
In Cunningham-Hill et al. who conducted their cohort study of 189 137 cases, SLR use was noted in 67.4%. Bleeding and reoperation were significantly higher in the cohort without SLR utilization, with no difference in mortality and staple line leak rates between the cohorts, which means that all the aggregate complications were similar between study cohorts, except for a higher bleeding rate without SLR use (P = 0.0005).
In consistent with our result, Dapri et al. showed that postoperative leaks appeared in one patient (group 1), two patients (group 2), and one patient (group 3).
In the current study, we found that BMI decreased in both groups after 1 and 6 months, but the differences between two groups were insignificant. Inconsistent with our result, Hany and Ibrahim showed that mean BMI (kg/m2) after 1 month was 43.57 ± 6.43 for group A and 43.38 ± 7.48 for group B. Mean excess weight loss percentage after 1 month was 17.58 ± 4.84% for group A and 17.29 ± 8.61 for group B, with no statistically significant difference between both groups.
In current study, we found that the operative time was longer in group A than group B, with significant differences between them, but regarding hospital stay, it was shorter in group A but did not reach statistical significance between the two groups. The study by Gayrel et al. showed that the mean hospitalization period was shorter in the study group (buttressing group) than in the control group.
Cunningham-Hill et al. agreed with our result in that SLR utilization was associated with longer operative duration (minutes) (75.1 vs. 72.5, P = 0.0001), but regarding postoperative length of stay (HLOS) (days), they found that postoperative length of stay was 1.7 versus 1.6 in SLR use versus nonuse, with significant differences (P = 0.0001).
On the contrary, Elbalshy et al. showed that there was no significant difference between both groups regarding operative time and staple line bleeding or leakage in their study, where they compared staple line fixation versus nonfixation to reduce postoperative complications.
In the current study, we found that readmission happened in two patients in group A (6.7%) and one patient in group B (3.3%), and one patient had been reported for reoperation in group B (3.3%). On the contrary, Gayrel et al. showed that a total number of five (4.3%) patients from the control group required further surgery for septic or hemorrhagic complications. None of the patients in the buttressing group had to be repeated.
In our work, we stressed avoiding creating stricture at the incisura angularis. There is some evidence to suggest that a meticulous technique which includes use of appropriate cartridge size, avoidance of distal narrowing, and careful use of energy devices especially near the gastroesophageal junction is a very important issue in prevention of gastric leak [19–21].
Bleeding is another major complication in LSG. Bleeding usually occurs from the staple line but may also happen from the resected greater omentum. There are numerous methods, including buttressing material, clipping and oversewing, and our study of staple line imbrication, which decrease the chances of staple line bleeding. However, compression time after application of stapler is also important. In a study by Kasalicky et al., they recommended 60 s of compression of the stapler upon stomach tissue before firing the reloads. Stricture formation may be owing to overzealous suturing. It is advisable to direct the anesthetist to push bougie distally, after completion of imbrication of the staple line to ensure that there is no excessive narrowing. Surgeons should avoid the asymmetry of the reinforcement suturing over the staple line, which may lead to stenosis, and using large-size bougie. We recommend '40 Fr' may decrease its incidence.
As surgical staplers are responsible in part for the current popularity of bariatric surgery since the procedure have become increasingly safe and efficacious.
Our knowledge and accumulation data from other studies reveal there are wide range of differences in surgeon experience, skills, technique, surgical protocol, postsurgical care, and health institute resources. With higher level of resources including human and financial supplies, it will lead to improvement in the outcome; decrease mortality, morbidity, and leak rates; reduce operating time; and reduce costly complication and hospital length of stay.
So, it is important to recommend the health authority to improve surgical skills like laparoscopic dissection using vessel-sealing devices, stapling using different type of staplers, clipping and suturing technique by training centers, and relative standardization of surgical technique and improvement of learning curve.
| Conclusion|| |
Our pilot study has shown that reinforcement by staple line imbrications, a step in LSG, is safe, technically easy, of low cost, and can reduce the incidence of postoperative complications, as bleeding and leakage, although it may lead to increase in the rate of stricture and significantly prolongs the operative time. This pilot study shows that reinforcement of staple line is beneficial and decreases the incidence of leakage and bleeding during the LSG. Further randomized controlled studies with larger sample size would be of great value to provide support for the result.
Further randomized controlled studies with large number of patients are recommended to prove our results.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]