OBES SURG DOI 10.1007/s11695-017-2760-0

ORIGINAL CONTRIBUTIONS

Three-Trocar Sleeve Gastrectomy vs Standard Five-Trocar Technique: a Randomized Controlled Trial Vincenzo Consalvo 1

&

Vincenzo Salsano 2,3 & Gerardo Sarno 4 & Iphigenie Chaze 3,5

# Springer Science+Business Media New York 2017

Abstract Purpose Bariatric surgery is a treatment for morbid obesity. Different surgical procedures have been described in order to obtain excess weight loss (EWL), but currently laparoscopic sleeve gastrectomy is the most commonly performed procedure throughout the world. Reducing abdominal wall trauma and increasing the aesthetic result are important goals for all bariatric surgeons. We conducted a randomized, controlled trial in order to assess if the three-trocar sleeve gastrectomy can be safely carried out or should be abandoned. Materials and Methods From September 2016 to February 2017, 90 patients were enrolled in our trial. Each patients

* Vincenzo Consalvo [email protected]; [email protected]; http://www.unisa.it Vincenzo Salsano [email protected]; http://www.clinique-du-parc.net/; http://www.chirurgie-digestive-montpellier.fr; http://www.ocsante.fr/etablissement/presentation-448.html Gerardo Sarno [email protected]

was evaluated by a multidisciplinary team before surgery. Two groups were created after application of the inclusion and exclusion criteria. The primary endpoint was to define the features of early post-operative complications of patients in group 1 (the three-trocar technique—the experimental group) compared to group 2 (five-trocar technique—the control group). The secondary endpoints were to evaluate any differences between the two groups concerning postoperative pain and patients’ satisfaction with the aesthetic results. Results There was no difference between the two groups concerning age, sex distribution, weight, and BMI. The rate of co-morbidities was similar in both groups. Operative time was inferior in the control group, but patient satisfaction was better in the three-trocar sleeve gastrectomy group. Conclusions The three-trocar sleeve gastrectomy can be safely carried out with a modest increase in operative time, without additional early surgical complications and with a greater patient aesthetic satisfaction. Trial Registration researchregistry2386. Keywords Laparoscopic sleeve gastrectomy . Three-port sleeve gastrectomy . Three-trocar sleeve gastrectomy . Complication of sleeve gastrectomy . Reduced port sleeve gastrectomy . Three-trocar sleeve gastrectomy

1

Università degli Studi di Salerno, Via Giovanni Paolo II, Fisciano, SA, Italy

2

Clinique Clementville Montpellier, 25 Rue de Clementville, Montpellier, France

3

Clinique du Parc Montpellier, 50 Rue Emile Combes, Montpellier, France

Introduction

4

Azienda ospedaliero universitaria san Giovanni di Dio e Ruggi d’Aragona, Via San Leonardo, Salerno, Italy

5

Department of Gastroenterology, Clinique Clementville Montpellier, 25 Rue de Clementville, Montpellier, France

Bariatric surgery is a recognized and valid treatment for morbid obesity [1]. Not only does it provide a better quality of life, but there is also scientific evidence demonstrating increased long-term survival in patients who

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have undergone the surgery [2]. Different surgical procedures have been described in order to obtain excess weight loss (EWL). Currently, operative patterns show a progressive decline in laparoscopic adjustable gastric banding (LAGB), and an increase in procedures such as Roux-en-Y gastric bypass (RYGBP) and laparoscopic sleeve gastrectomy (LSG) [3]. LSG was first described by Regan et al. [4] as a part of a multi-step approach in super obese patients due to the technical difficulties in performing the RYGBP; currently, it is the most commonly performed bariatric surgical procedure in France [5] and all over the world [6]. Due to this high frequency of use, further reducing abdominal wall trauma and improving the esthetic results of LSG are an interesting topic of research among bariatric surgeons [7]. The three-trocar sleeve gastrectomy technique was described by several authors [7–10], but none of these studies were randomized, to our knowledge. We decided to conduct a randomized controlled trial in order to assess if the three-trocar sleeve gastrectomy can be safely carried out or should be abandoned. The trial was designed assuming two parallel groups within a framework of non-superiority for the experimental group. The endpoints are clarified in the methods section.

Methods and Materials Objectives The main purpose of this trial is to define the safety of the three-trocar sleeve gastrectomy compared to the classical fiveport technique.

In this controlled trial, we decided to blind our data analyst in order to avoid any possible error or bias. Recruitment, Indications, Inclusion, and Exclusion Criteria From September 2016 to February 2017, 90 patients from our 2 institutions were enrolled in the trial. Each patients was evaluated by a multidisciplinary team before surgery (nutritionist, endocrinologist, gastroenterologist, cardiologist, pneumologist, psychiatrist, psychologist, anesthesiologist, and bariatric surgeon). The indication for sleeve gastrectomy was given following the recommended indications of the International Federation for the Surgery of Obesity (IFSO) by all specialists involved. For the bariatric surgeon, the indications were a body mass index (BMI) >40 or >35 kg/m2 with the at least one comorbidity, the failure of conservative treatment for 2 years, and patient age between 18 and 65 years. All patients that accepted the research study prospective and the risks/benefits of having the three-trocar technique surgery were included in the study. Exclusion criteria included the presence of an undetected large hiatal hernia, significant gastroesophageal reflux disease (GERD), and all the contraindications to major surgery. In the cases of an undetected hiatal hernia, we had to change the surgery to a Roux-en-Y gastric bypass procedure, and patients were excluded from the trial. For ethical reasons, we included in our protocol that any patients with significative intraoperative bleeding (>500 cm3 in the aspirator) should be converted from the three- to five-trocar technique or to open surgery and thus would be excluded from the trial. Endpoints

Ethical and Administrative Information The work described has been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans and approved by a local committee. The trial was registered in the public registry: http://www.researchregistry.com/browsethe-registry.html#home/ with the following unique identification number (UIN): researchregistry2386. This trial was conducted according to the SPIRIT 2013 guidelines (Standard Protocol Items: Recommendation for Interventional Trial) [11]. A special informed consent was explained and signed by all patients. All patients accepted the anonymous form of publication for scientific purposes and the storage of data in a database. The authors declared that there would not be any communication of personal data to third parties, in order to respect patients’ privacy.

The primary endpoint was to define the differences in the early post-operative complications of patients who underwent the three-trocar technique (group 1, the experimental group) versus patients who underwent the five-trocar technique (group 2, the control group). The framework of non-superiority was applied for group 1. The secondary endpoints were to evaluate any differences between the two groups concerning post-operative pain and patient satisfaction of the esthetic result. Randomization Patients were assigned to group 1 or group 2 using a computer-based stratified randomization program with results placed in sealed envelopes. Six enrolled patients had administrative problems regarding reimbursement assurance and were operated on after the recruitment

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Fig. 3 Trocar position in three-trocar sleeve gastrectomy

Operative Techniques

Fig. 1 Algorithm showing schematically the randomization process and patients selection. See text for detailed inclusion and exclusion criteria

period, and they were thus not included in the trial. Furthermore, two other enrolled patients had a considerable intraoperative undetected hiatal hernia and were excluded because they were crossed over to a gastric bypass procedure. No massive bleeding was recorded in the two groups. In the end, 82 patients were included in the study (Fig. 1). According to the standards defined in the International Sleeve Gastrectomy Expert Panel Consensus Statement of 2011 [13], the leak rate was 1.06%. To have a statistical power of 95%, we had to recruit at least 40 patients per group (P = 0.041), and since 40 patients were assigned to group 1 and 42 to group 2, we concluded that the sample size after the randomization was adequate to detect a statistically significant result.

Fig. 2 Showing Veress needle insufflations and drawing the trocar site

Surgical procedures were performed by two surgeons after the standardization of the technique. The only difference between the two groups was the number and position of the trocars. Insufflation was achieved with a Veress needle to just 15 mmHg of intra-abdominal pressure (Fig. 2). A three-trocar technique was used in the experimental group (Fig. 3). Local anesthetic (ropivacaine 3%) was administered before any trocar incision. The optical port was placed 11 cm vertically and caudally from the xiphoid process. A second 12 mm trocar was placed on the left midclavicular line, 2 cm below the horizontal line crossing the optical port. A third 5 mm trocar was placed higher on the left at approximately 8 cm from the second port. Optics were inserted in the second trocar, which became the new optical one while the previous optical port became the working port for the left hand. Liver retraction was achieved by using three compacted gauzes under the left lobe of the liver (Fig. 4). The control group trocar positions were different. The first two trocars were placed in the same position as the

Fig. 4 Liver retraction with gauzes in three-trocar sleeve gastrectomy

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Fig. 5 Specimen extraction after three-trocar sleeve gastrectomy

experimental group, but the third one was placed lower on the left anterior axillary line. Two additional 5 mm trocars were placed as follows: one on the right midclavicular line and another one 10 cm laterally on the right for liver retraction. The calibration tube used was 36 Fr. The distance from the pylorus was 5 cm. After freeing the great curvature of the stomach, the omentum, and any retro-omental adhesions with Ligasure® (Medtronic), the stomach was stapled by using a 6 cm purple cartridge (Medtronic). Five or six of these cartridges were used. No reinforcement of the suture line was carried out. Hemostasis was confirmed. No blue methylene test was performed. No drain was placed. The nasogastric tube was immediately removed as was the calibration tube. Specimen extraction was achieved from the median 12 mm port without any skin incision enlargement (Fig. 5). The 12 mm fascial defect was closed with a 0.0 resorbable suture.

Bleeding is defined as a loss of >3.99 g/dL of Hb value between pre- and post-operative assessments or Hb <7.0 g/dL in the post-operative period. Dysphagia is defined as difficulty in swallowing; sensation of a block for solids or liquids persisting for less than 15 days. Obstruction/stenosis is defined as difficulty in swallowing; sensation of a block for solids or liquids persisting for more than 15 days. Stenosis was diagnosed if medical intervention was required. Infection/peritonitis is defined as clinical symptoms of tachycardia and WBC >15,000/mL without radiological finding of fistula when performing a contrast swallow test. Wound infection/parietal hematoma is a diagnosis based on clinical observations only. Non-surgical complications include pulmonary emboli, myocardial infarction, adverse drug reactions, medical pancreatitis, acute renal failure, and other complications. Operative Time Definition Operative time counting started with Veress needle introduction and was finished with the last trocar skin wound closure. Patient Follow-Up After the surgical intervention, patients were started on a liquid diet on day 2 and were discharged on day 3. Follow-up consultations with patients occurred on day 7, day 15, and day 30. Satisfaction of Patients

Definition of Surgical Complications Leak was defined as clinical symptoms of tachycardia, WBC (white blood cells) >15,000/mL, plus radiological findings (CT/X-ray) of a fistula when performing a contrast swallow test. Furthermore, a leak was defined as Bearly^ if it was clinically detectable at day 2 and as Bdelayed^ in other cases. The major period of risk for clinical manifestations of a leak is between days 10 to 15 [12], and we considered the leak diagnosis to be negative in any patient without clinical signs at day 30. Fig. 6 Questionnaire to test patients’ satisfaction

There were no available questionnaires for our purpose in the literature so we were obliged to create a new model (Fig. 6). Statistical Analysis All data were analyzed with the software InStat by GraphPad® Vers.3.10, 32-bit for Windows, 2009 version. The Mann-Whitney test was used in order to match quantitative variables (age, operative time). Fisher’s exact test was

Questions

Answers

1. How much do you feel satisfied about post operative analgesia?

My answer is (1 to 10) .................................

2. How much do you feel satisfied about the aesthetic impact of the incisions?

My answer is (1 to 10) .................................

3. Overall, how much do you feel satisfied?

My answer is (1 to 10) .................................

4. If you had 5 incisions, would you have preferred to have 3 incisions? (reserved to patients operated with 5 trocars)

Yes Indifferent No

OBES SURG Table 1

Patient demographics and co-morbidities The trocars (N = 40)

Five trocars (N = 42)

P value

Significant (S)/Non significant (NS)

Age Mean ± SD

36.2 ± 10.7 (18–55)

36.5 ± 9.7 (18–56)

0.9303

NS

Initial BMI Mean ± SD

41.9 ± 4.75 (35–55)

40.8 ± 4.9 (35–55)

0.2954

NS

Male/female (N) Hypertension (N)

17/25 19

13/27 25

– 0.3758

– NS

Diabetes (N)

10

12

0.8053

NS

Dyslipidemia (N) OSAS (N)

5 30

11 27

0.1648 0.3425

NS NS

Arthralgia (N) Depression (N)

12 11

14 9

0.8148 0.6106

NS NS

N number, SD standard deviation

used for the analysis of the contingency table of complications and pre-operative co-morbidities between the experimental and control groups. The two-tailed t test was used to match means of unpaired data (BMI, weight) at 0 and 1 month.

Results Patient Characteristics A total of 82 patients were included in the trial. Forty patients underwent three-trocar sleeve gastrectomy, while 42 underwent the classical five-trocar technique. There was no significant difference between the two groups concerning age, sex distribution, weight, and BMI. The rate of co-morbidities was similar in both groups (Table 1 for details).

Table 2

The mean operative time was inferior in the five-trocar technique (43.1 ± 8.5 min with a range of 30–66 min) compared to the three-trocar technique (51.5 ± 10.53 min with a range of 35–71 min), and the statistical analysis showed a two-tailed P value of 0.0004, which was considered extremely significant. Despite the shorter operative time, intra-operative bleeding (>250 cm3) was similar in both groups with a two-sided P value of 0.2349, which was considered not significant. Mortality and the conversion rate to open surgery were 0%. Overall morbidity was not significantly different in the two groups. All complications and analyses are listed in Table 2. The early mean BMI ± SD at post-operative month 1 was 39.2 ± 4.35 (34–51) for the three-trocar group and 38.4 ± 4.1 (33–52) for the five-trocar group. The two-tailed P value was 0.3938, which was also considered not significant (Fig. 7).

Report of post-operative complications and relative risk Three trocars (N = 40)

Five trocars (N = 42)

Fisher’s exact test P value (Sa/NSb)

Relative risk (95% confidence interval)

Leak Bleeding (postoperative) Obstruction/stenosis Infection/peritonitis Dysphagia Trocar site hernia Wound infection/hematoma

0 1 1 0 2 0 2

0 2 0 0 1 0 2

NGc P = 1.00 (NS) P = 0.48 (NS) NG P = 0.61 (NS) NG P = 1.00 (NS)

NG 0.67 (0.13–3.4) 2.07 (1.657–2.604) NG 1.39 (0.60–3.18) NG 1.06 (0.37–2.8)

Non-surgical complications

1

0

P = 0.48 (NS)

2.07 (1.657–2.604)

Surgical complications

Major

Minor

Differences reported were not statistically significant a

Operative Time and Complications

S significant

b

NS not significant

c

NG not given

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Fig. 7 Evaluation of BMI reduction at postoperative month 1

Questionnaire Results Questionnaires were given before each patient’s discharge. The results showed a high overall satisfaction for both groups. The three-trocar group had a significant improvement in the esthetic satisfaction of the patients. Overall satisfaction and pain perception after the procedure was not different between the two groups (Table 3). Question n. 4 was only provided to patients in the control group. Of the 42 patients, 100% of female and 95.2% of male patients declared they would have preferred to have three incisions rather than five, while 4.8% of the male population declared they were indifferent to the number of trocars.

Discussion This is the first randomized controlled trial comparing the safety of three-trocar sleeve gastrectomy with the classical five-port technique. The primary endpoint evaluation found that complications were not increased with the three-trocar technique. Post-operative bleeding was the most common major surgical complication we found, even though con-

Table 3 Indicating the questionnaire results and statistical analysis Q1 Q2 Q3

servative management was sufficient in all three cases. We had a case of obstruction due to a persistent intragastric hematoma requiring a gastroscopy at day 20; however, in this case, conservative management was also adopted without consequence. No cases of leaks or peritonitis were observed. The incidence of other minor complications was not significantly different between the two groups. Intra-operative time was shorter for the classical sleeve gastrectomy, but we underline that if we compare the means of the two operative times, the three-trocar technique required only eight additional minutes of intraoperative time. In our opinion, this delay can be justified by the advantage in the esthetic impact on patients of the three-trocar technique. In fact, the secondary endpoint analysis, as demonstrated in question n. 2 of the survey, found increased satisfaction of patients concerning esthetic results with the three-trocar technique; furthermore, this perception was confirmed by question n. 4, in which nearly all patients (female and male) declared they would have preferred the three-trocar technique. Corcelles et al. [7] supposed inferior pain perception with the three-trocar technique due to the inferior abdominal wall trauma, but our data do not show a statistically significant difference in pain perception between the two techniques. We also found that overall patient satisfaction was not influenced by the technical choice of three or five trocars during the surgical procedure. Lastly, the early reports of BMI reduction at 1 month did not show relevant variations among patients operated on with three or five trocars. A larger follow-up period is needed in order to evaluate the real %EWL (% of excess weight loss) at 1 and 3 years.

Limitations We do not yet have long-term data concerning differences in %EWL and rates of repeat bariatric surgery between the two techniques.

Thee trocars mean ± SD (standard deviation)

Five trocars mean ± SD standard deviation)

P value (Mann-Whitney test)

Significant (S)/Non significant (NS)

8.9 ± 1.53 9.1 ± 1.08 9.27 ± 0.96

8.83 ± 1.48 8.19 ± 1.53 9.00 ± 1.03

P = 0.653 P = 0.0036 P = 0.1858

NS S NS

See the attached questionnaire to have informations about questions

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Note of Caution

3.

An appropriate learning curve in bariatric surgery is necessary before starting the three-trocar technique.

4.

5.

Conclusions 6.

Three-trocar sleeve gastrectomy can be safely carried out with a modest increase in operative time, without additional early surgical complications and with greater patient esthetic satisfaction.

7.

8. Compliance with Ethical Standards Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

9. 10.

Conflict of Interest The authors declare that they have no conflict of interest.

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