Today, MGB-OAGB, a mini-gastric bypass or one anastomosis gastric bypass, is one of the most
widely used bariatric procedures. This surgery was first performed by Professor R. Rutledge
in 1997, having published the first data in 2001 on a sample of 1274 patients [1]. In 2014,
the first consensus conference was held, at which recommendations for application and
generalization of experience were adopted [2]. By 2018, the share of MGB-OAGB surgeries in
the world was already 7.7% [3]. In the Russian Federation, this index for 2021 was 12%, which
indicates a significant prevalence of mini-gastric bypass surgery in the Russian Federation
[4]. This is facilitated by the simplicity, safety and high efficiency of this procedure in
relation to obesity and metabolic disorders. Comparative studies and subsequent meta-analyses
show a number of advantages over the classic Roux-en-Y gastric bypass [5, 6]. Reduction in
the duration of the surgery and the reduction in the number of surgical complications are
attractive for surgeons.
However, with the increase in the number of surgeries and the accumulation of experience, a
number of problems associated with this surgery become apparent. Malabsorption risks are
minimized by measuring the length of the common loop and cutting off a strictly defined
percentage of the small intestine from digestion. Research on bile reflux effects is
currently ongoing, but in order to reduce it, the surgical technique has been modified by
lengthening the gastric tube [2]. One of the most serious problems is the appearance of
gastrojejunostomy (GJS) ulcers. As a rule, they are difficult to treat and can cause
bleeding. Their number seriously varies in different publications from 2% to 13% [7, 8].
These figures, despite the attractiveness of the new surgery, make many surgeons refrain from
performing MGB-OAGB in their routine practice. The causes of ulcers are not fully understood
and require further study, and it is also possible to change the technique of anastomosis.
Working Hypothesis We assume that the frequency of gastrojejunostomy ulcers after MGB-OAGB is
associated with the peculiarities of the side-to-side GJS formation, which is currently the
"gold standard" for this procedure. The geometry of such anastomosis leads to the formation
of a narrow strip of the gastric wall between two stapler lines (between the suture from the
2nd cassette during the formation of the "small ventricle" and directly from the suture from
the cassette during the GJS formation). Perhaps this section of the stomach wall is prone to
ischemia, which can certainly increase the risk of ulcer formation. It is also possible that
a zone with impaired blood supply may also form in the "blind pocket" above the anastomosis.
When forming a Hand-sewn GJS of the end-to-side type, ischemia zones do not occur. The
anastomosis has a more physiological geometry, there is no conflict between the lines of
stapled sutures.
Thus, we put forward the assumption that a serious risk factor for the development of a GJS
ulcer was eliminated when switching to a completely Hand-sewn technique for the GJS formation
when performing MGB-OAGB.
Purpose of the Study To compare the incidence of GJS ulcers during MGB-OAGB, depending on the
techniques of anastomosis formation.
Materials and Research Methods In order to assess the target parameter and the endpoint of
the study, all patients who underwent surgical treatment will undergo a video endoscopy of
the upper gastrointestinal tract 6 months after surgical treatment.
As research tools, it is planned to use instrumental, laboratory and surgery equipment, as
well as all other necessary material and technical equipment of the above medical
institutions.
Treatment Protocol All eligible and randomized patients will undergo laparoscopic MGB-OAGB no
later than 1 month after randomization and enrollment. As part of a standardized preoperative
assessment, a set of examinations will be performed, see Appendix 2.
Standardized surgery protocol:
One-time antibacterial prophylaxis is performed, activities are carried out for the
induction of anesthesia, tracheal intubation and the implementation of inhalation
anesthesia with mechanical ventilation in accordance with the local standards of the
participating centers.
Patient is placed in the supine position with the head of the bed elevated at 30°
(Fowler's position).
A carboxyperitoneum is created with a pressure of 12-16 mm Hg.
Five trocars are installed in the upper mesogastrium according to the accepted technique
for performing surgical interventions on the upper floor of the abdominal cavity in each
specific clinical center.
By one of the types of surgical energy (ultrasound, bipolar, monopolar) along the lesser
curvature of the stomach, the lesser omentum is dissected and the omentum is entered
from the omental bag at or distal to the crow's foot, the minimally necessary
retrogastric adhesiolysis is performed.
The gastroesophageal junction and the angle of His are mobilized. Then the stomach is
transected using linear endoscopic staplers in such a way as to create an isolated
narrow gastric tube ("small ventricle") at least 17-18 cm long and 15-20 mm wide
(diameter of gastric tube used 36-39 Fr). Blue, green, gold, purple, and black cassettes
(cassettes or cartridges in blue, green, black, or purple) can be used.
Staple line hemostasis by applying clips.
The greater omentum may be transversely incised depending on individual anatomy.
Visualization of the ligament of Treitz.
Measurement of the length of the small intestine at a distance of at least 5 m.
A gastroenterostomy is performed at a distance of 150-200 cm from the ligament of Treitz
using a linear stapler in group A and using a fully Hand-sewn suture in group B.
Gastrotomy at the end section of the stapler line of the distal "small ventricle" and
enterotomy at 150-200 cm from the ligament of Treitz are performed in group A. GJS is
formed using a blue or purple cartridge (the height of the braces is 3.5 mm). The width
of the formed anastomosis is calibrated according to the branch of the apparatus of
35-40 cm. The technological hole is closed with absorbable monofilament suture material
with a biodegradation time of not more than 180 days on a pricking needle.
Extended gastrotomy by cutting off the end stapler line (1st cassette, when forming the
"small ventricle") is performed in group B. Enterotomy with a length of 35-40 mm is
performed at a distance of 150-200 cm from the ligament of Treitz. GJS is formed by a
manual single-row continuous suture using any absorbable monofilament suture material
with a biodegradation period of not more than 180 days on a pricking needle.
Performing an anastomosis leak test with a solution of methylene blue or bubble leak
test.
Testing for hemostasis.
Desufflation of gas and suturing of trocar wounds are carried out.
After the surgical intervention, if necessary, the patient can be in the intensive care unit
and monitoring until the stabilization of the condition, then transferred to the specialized
surgical department.
Recommendations for nutrition after surgery: oral intake of light glucose-containing liquids
begins on the first postoperative day (6-12 hours after surgery). On the second day after the
surgery, the intake of concentrated glucose-containing and complex nutritional drinks begins.
After discharge from the hospital, the patient must adhere to the protocol diet (Appendix 3).
All patients will be required to take preventive therapy with an established PPIs 40 mg daily
for 6 months after surgery.
Intermediate Control From the moment of discharge from the hospital until the moment of
assessment of the target parameter, remote monitoring will be carried out to control the
patient's compliance (regularity of PPI intake, adherence to recommendations on the
postoperative diet) and complaints, possibly associated with the early onset of erosive and
ulcerative lesions of the upper gastrointestinal tract. Telephone control will be carried out
in periods of 1, 2, 3 and 5 months after surgical treatment.
In the event of a premature referral of the patient or detection of complaints during the
intermediate control, indicating the possible development of erosive and ulcerative lesions
of the upper gastrointestinal tract, the patient will undergo a premature flexible endoscopy
of the upper gastrointestinal tract. If a GJS ulcer is detected, the endpoint will
prematurely be assessed as positive.
Expected Results It is expected to reveal a statistically significant reduction in the
incidence of GJS ulceration when performing MGB-OAGB using a Hand-sewn anastomosis technique
compared with a stapled technique.