JSUR Journal

Introduction

A statistical analysis from 2021 indicates that 52.7% of adults in Germany are overweight. Compared with other Organization for Economic Cooperation and Development (OECD) countries, Germany ranks 21st in the proportion of overweight adults [1,2]. The development of bariatric and metabolic surgery (BMS) has experienced incredible growth in recent years, both nationally and internationally, following its recognition as a treatment modality for obesity and related diseases [3,4]. Furthermore, advancements in minimally invasive surgery have been consistently pursued. Even more innovative is robotic-assisted surgery, which has gained acceptance in many surgical specialties, and is increasingly used in BMS [5-7]. This development has improved patient outcomes after BMS in terms of postoperative recovery and lower hospital costs [8]. However, some surgical procedures have gained more acceptance than others because they provide better long-term results [9-11]. In addition, the expected goal of surgery, which varies from patient to patient, influences the choice of operation method [12,13]. Factors that could affect the decision of surgery are the patient’s general health, current weight, surgeon’s experience, and medical history [14]. The development of laparoscopic and robotic approaches leads to several changes in operation techniques with using several kinds of sutures or staplers. These several devices also may be influencing the perioperative and short-term outcome [15,16]. Gastrointestinal anastomosis constitutes a vital phase in numerous laparoscopic and robotic bariatric surgical interventions. Depending on the experience of the surgeons and the equipment of the hospital, these anastomoses are usually performed using a handsewn, linear or circular stapling device or a combination of several procedures. Laparoscopic intracorporeal suturing is regarded as one of the most laborious and time-intensive components of this surgical procedure [17-19]. The aim of the following study is to analyze the outcome within utilizing the suture technique PDS^TM II Ethi-Endo-Clip Suture Set (Ethicon, Raritan, NJ, USA). To evaluate this data, we performed a single-center study from 01.01.2020 until 31.05.2024 using the Ethi-Endo-Clip Suture in patients with Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Mini-Gastric Bypass (LMGB) as a primary as well as a revisional procedure following Sleeve Gastrectomy (SG).

Material and Methods

Data Collection and Inclusion Criteria

Data were prospectively collected from January 1, 2020, to May 31, 2024, and subsequently analyzed retrospectively. The investigation included primary (P) LRYGB and LMGB, as well as Secondary (R) LRYGB and LMGB subsequent to Sleeve Gastrectomy (SG), utilizing the Ethi-Endo-Clip Suture. All participants completed a one-year follow-up period and were at least 18 years old. Only individuals possessing complete data were included in the study. The postoperative data were collected within 30 days postoperatively and at 3, 6, 12 and 24 months.

Statistical Analyses

The statistical analysis was performed using SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA). All analyses were conducted in an exploratory manner. Thus, the full level of significance of 5% was deliberately used. The results tables display the mean value and standard deviation (STD) for (quasi-) continuous variable distributions, or also for log-transformed data in case of non-normal distribution, the mean value and simple range of dispersion after back-transformation. Contingency tables display the Absolute (N) and Relative (%) frequencies for categorical variables. Univariate analyses – unadjusted for confounders - for the surgical techniques were conducted: the chisquare test and an ANOVA for categorical and continuous outcome variables, respectively.

Surgical Technique

P-LRYGB and R-LRYGB

Following the typical setting of the patient, the surgical area is disinfected and draped, and a team time-out is conducted. Incision of the skin on the left paramedian approximately 15 cm inferior to the xiphoid process and insertion of the camera trocar. Establishment of a pneumoperitoneum at a pressure of 15 mm Hg. Diagnostic laparoscopy. A 5 mm trocar is now introduced into the epigastric angle, a 12 mm trocar into the left upper quadrant, and a 12 mm trocar into the right upper quadrant. The transverse colon is then relocated to the upper quadrant, with the duodenojejunal flexure observed adjacent to the inferior mesenteric vein. Measurement of a 60-centimeter biliary loop. A Dexon clip is utilized for marking and is secured to the anticipated gastric remnant with an anchoring and secure suture using a PDS^TM Ethi-Endo-Clip Suture (Figure 1). Proceed to the lesser omentum at the level of the second vascular arcade. Transect the stomach utilizing a gold endoscopic linear stapler. Construct the gastric pouch precisely utilizing a 24 Fr. calibration tube and incorporating two supplementary blue endoscopic linear staplers (in primary RYGB but not in SG to RYGB). Mobilization of the stomach pouch and its incision over the positioned calibration tube. Incision of the small bowel loop, release of the securing suture. Anastomosis of the stomach to the small intestine across a distance of 50 mm utilizing a blue endoscopic linear stapler. Ongoing closure of the anterior wall Running closure of the anterior wall with barbed suture technique. Reinsertion of the calibration tube and conducting a leak test with methylene blue. No evidence of extravasation is present.

Preparation of the anticipated transection site of the biliary loop is now underway. Measurement of an intestinal loop measuring 150 cm in length. This is secured at the position of the attached Dexon clip. Creation of the alimentary and biliary loops around 6 cm distal to the securing suture, followed by anastomosis using a laterolateral suture technique. Closure of the entrance aperture via a continuous barbed suture. Closure of the Peterson space via a continuous Mersilene suture. Proceed to sever the biliary loop at the site of the affixed Dexon clip, which has been previously excised. The blind loop is further sutured to the pouch using a PDS^TM II EthiEndo-Clip Suture (Figure 1). Another comprehensive examination revealed no hemorrhaging or foreign objects.

Figure 1: Illustration of the intraoperative application of the PDS^TM II Ethi-Endo-Clip Suture.

P-LMGB and R-LMGB

In accordance with standard protocol, the patient is positioned in a 30° reverse Trendelenburg position, the surgical site is cleansed and wrapped, and a team time-out is performed. Incision of the skin on the left paramedian approximately 15 cm inferior to the xiphoid process, followed by the insertion of the camera trocar. Creation of a pneumoperitoneum at a pressure of 15 mm Hg. Diagnostic laparoscopy. A 5 mm trocar is put into the epigastric angle, a 12 mm trocar is placed in the left upper quadrant, and a 12 mm trocar is positioned in the right upper quadrant. The transverse colon is then relocated to the upper quadrant, with the duodenojejunal flexure observed adjacent to the inferior mesenteric vein. Measurement of a 150-centimeter biliary loop. An anchoring suture using PDS^TM II Ethi-Endo-Clip Suture is performed to secure the small bowel to the anticipated gastric remnant. Incise the stomach utilizing a gold endoscopic linear stapler. Construct the gastric pouch precisely utilizing a 24 Fr. calibration tube and incorporating three supplementary blue endoscopic linear staplers. Mobilization of the stomach pouch and its incision over the positioned calibration tube. Incision of the small bowel loop, release of the securing suture. Anastomosis of the stomach to the small intestine across a distance of 50 mm utilizing a blue endoscopic linear stapler. Ongoing closure of the anterior wall via Running closure of anterior wall with a barbed suture. Reinsertion of the calibration tube and conducting a leak test with methylene blue. No evidence of extravasation is present. Another comprehensive examination revealed no hemorrhaging or foreign objects.

Results

189 patients were incorporated into the analysis. The PDS^TM II Ethi-Endo-Clip Suture was utilized in all patients for anastomoses, purse-string sutures, and cape repair sutures. Table 1 illustrates the distribution of surgical procedures utilizing the Ethi-Endo-Clip.

Table 1: Distribution of surgical procedures utilizing Ethi-EndoClip.

The gender distribution revealed a markedly higher proportion of females (77.2%) compared to males (22.8%), which was not significantly different between procedures (p = 0.076). The average age of patients was 45.5 (± 10.4) years for P-LRYGB, 51.5 (± 7.0) years for P-LMGB, 49.1 (± 11.8) years for R-LRYGB, and 50.4 (± 10.0) years for R-LMGB (p = 0.053). Patients with P-LMGB and R-LMGB exhibited a markedly elevated BMI compared to those with P-LRYGB and R-LRYGB (p<0.001). Table 2 presents the distribution of sex, BMI, and age specific to the surgical procedure.

Table 2: Distribution of gender, Body Mass Index (BMI), and age in relation to surgical technique.

Regarding the ASA classification, 49.2% of patients were categorized as ASA II, while 50.3% were classified as ASA III. A substantially greater proportion of patients classified as ASA III underwent P-LMGB compared to those who received P-LRYGB (93.8% vs. 39.0%). The conversion from LSG to LMGB (R-LMGB) occurred more frequently in patients classified as ASA III compared to R-LRYGB (59.6% vs. 43.3%) (Table 3). There were only 12.2% of patients who did not have any comorbidities (Table 3). Overall, the prevalence of T2DM was 21.2%. A P-LMGB was performed in 81.3% of patients with T2DM. This is considerably higher than the percentage of patients with P-LRYGB (13.6%). T2DM was also more frequently observed in patients who underwent R-LMGB than in those who underwent R-LRYGB (11.9% vs. 23.4%). Hypertension affected 69.3% of all patients, while OSAS affected 23.3%. GERD was more prevalent in patients with P-LRYGB than in those with P-LMGB (50.8% vs. 6.3%). Additionally, patients who underwent R-LRYGB experienced a greater degree of GERD than those who underwent R-LMGB (38.8% vs. 8.5%). The aggregate prevalence of nicotine abuse was 2.6%.

(T2DM = Diabetes Mellitus Type II, IDDM = Insulin-Dependent Diabetes Mellitus, NIDDM = Non-Insulin-Dependent Diabetes Mellitus, OSAS = Obstructive Sleep Apnea Syndrome, GERD = Gastroesophageal Reflux Disease)

Table 3: ASA classification and the incidence of comorbidities.

Operation Time and Complications, Hospitalization and Postoperative Stay

There was a significant difference in average operation time (p<0.001), which was by far the shortest for R-LMGB (54.6 [53.4; 55.9] minutes). There was a significant difference in the operation time between surgical procedures, but this was numerically not noticeable between the P-LRYGB (92.5 [91.2; 93.7]) and the R-LRYGB (90.5 [89.3; 91.8]), as shown in Table 4. As a consequence of a splenic lesion, one patient in the P-LRYGB group underwent conversion to an open procedure. The P-LMGB group (n = 1) also experienced a conversion to an open procedure. Consequently, the cumulative conversion rate for four surgical procedures was 1.1% (n = 2).

Table 4: Mean duration of primary and revision surgery (test on log-transformed values).

The overall rate of intraoperative complications was 3.2% (n = 6). There was just one relevant complication associated with the spleen injury, necessitating the conversion to open surgery. General complications arose in 3.2% (n = 6). The specific complication rate was 2.6% (n = 5). In two cases, gastroscopic intervention for anastomotic hemorrhage is required, whereas one patient necessitates laparoscopic intervention. The incidence of Anastomotic Insufficiency (AI) or Anastomotic Stricture (AS) was 0% across all surgeries according to the data (Table 5).

Table 5: Incidence of intraoperative and postoperative complications.

 A patient developed peritonitis because of minor bowel leakage at the anchoring suture. The correction was performed laparoscopically with oversewing of the leak. The patients who had conversion to open surgery due to splenic injury need treatment for a wound infection. No mortality was observed in the investigated individuals. Table 6 presents the duration of hospitalization and postoperative stay.

Table 6: Hospitalization time and postoperative stay.