Clinical trial NCT04861961: Comparison of Three Hypoabsortive Surgical Techniques for Treatment of Type IV Morbid Obesity
Official title: Prospective Randomized Study Comparing Three Hypoabsortive Techniques for the Treatment of Type IV Obesity: Double-anastomosis Duodenal Switch (DS), Single- Anastomosis Duodenal Switch SADI-S) and One Anastomosis Gastric By-pass (OAGBP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Morbid Obesity
Keywords: Bariatric Surgery
Morbid Obesity
Hypoabsortive surgery
Duodenal Switch
SADI-S
One-anastomosis gastric by-pass
Gastro-esophageal reflux
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized study comparing three bariatric surgical techniques
Primary purpose: TREATMENT

Brief summary: Morbid obesity is the first non-traumatic cause of death in the western population and it is also progressively beginning to affect the developing countries. Bariatric surgery provides better results than pharmacological treatments and lifestyle changes, granting a better control of comorbidities.

Duodenal switch (DS) has proben to be the most effective surgical treatment for grade IV morbid obesity and its comorbidities. However, it is not widely used due to its technical complexity and the risk of long-term complications. Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S) was concieved in 2007 as a one-anastomosis simplification of DS, intended to diminish the surgical time and postoperative risks. Recently, another simplified hypo-absorptive technique has started to be widely used: the one anastomosis gastric bypass (OAGBP), also called mini-gastric gypass. It consists of a gastric pouch associated with a gastro-jejunal anastomosis in omega (Billroth II). Despite the potential advantages of these emerging surgical techniques (SADI-S and OAGBP), there is no solid evidence on its efficacy for the treatment of grade IV obesity in comparison with DS. Besides, there is also there is a lack of studies reporting on prospective acid and bile reflux after omega digestive reconstructions, suche as "Billroth II-like" (SADI-S) and "Billroth II" (OAGBP). Bile reflux is potentially premalignant condition.

This prospective randomized study aims to compare conventional DS with SADI-S and OAGBP. We include all morbidly obese patients with BMI ≥ 50 kg/m2 aged 18 years or more. Exclusion criteria are patients who do not fulfill our preoperative bariatric assessment for surgery and those with contraindications for hypo absorptive or mixed surgery.

The main objective of the study is to compare the percentage of excess weight lost at 2 and 5 years after the three different surgical procedures. As a secondary objective, gastroesophageal reflux (GERD) will be compared before and 2 years after surgery, based on GERD symptoms test, gastroscopy and a esophageal pH-impedanciometry in selected patients. Other secondary objectives are comparison of short-term complications, metabolic comorbidities, depositional habit, quality of life and metabolic and nutritional deficiencies at two years of surgery.

Detailed description: Morbid obesity is the first non-traumatic cause of death in the western population and it is also progressively beginning to affect the developing countries. Bariatric surgery provides better results than pharmacological treatments and lifestyle changes, granting a better control of comorbidities.

Duodenal switch (DS) has shown to be the most effective surgical treatment for morbid obesity and its comorbidities. However, it is not widely used due to its technical complexity and the risk of long-term complications. In 2007 Drs. Sánchez-Pernaute and Torres introduced a simplified version of the DS technique: Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S). SADI-S consists of a vertical gastrectomy (VG) and a duodenum-ileal anastomosis preserving the pylorus with jejunal exclusion and a total common-alimentary loop originally of 200 cm and later standardized to 300 cm to reduce the risk of nutritional deficits. In order to diminish the surgical time and postoperative risks an omega reconstruction is performed without an ileo-ileal anastomosis. SADI-S can be performed either directly as primary surgery, planned in two stages, or as revisional surgery in case of insufficient weight loss or weight regain after VG. In terms of weight loss and comorbidity resolution, SADI-S' reported results are similar to those reported in historical DS series, but no prospective comparative studies have been published.

Recently, another simplified hypo-absorptive technique has started to be widely used: the one anastomosis gastric bypass (OAGBP), also called mini-gastric gypass. It consists of a gastric pouch associated with a gastro-jejunal anastomosis (Billroth II). It was initially described by R. Rutledge in 1997 and despite its first publication was in 2001, only lately it has been approved as a standard bariatric technique. OAGBP with a 200 cm biliopancreatic limb has shown good results in weight loss and control of comorbidities, higher than those achieved by VG and proximal Roux-en-Y gastric bypass (RYGBP) with 50 cm biliopancreatic limb and 150 cm alimentary limb, as it has been demonstrated in two prospective randomized studies and a recent meta-analysis. However, the OAGB results have not been compared with other hypo absorptive surgical techniques, such as DS or SADI-S.

In comparison to the DS, which has a Y-Roux reconstruction, SADI-s and OAGBP have a "Billroth II-like" or omega reconstruction. Despite the potential advantages of these emerging surgical techniques, bile reflux is the main issue of omega reconstructions. In our most recently published series including 440 consecutive patients, we reported that 1.7% of patients required conversion to DS due to symptomatic bile reflux. It would be reasonable to expect higher incidence of bile reflux in techniques with omega reconstruction that do not preserve the pyloric barrier, such as OAGBP. However, some authors claim that with a 200 cm biliopancreatic limb most of the bile is reabsorbed by the intestine before it reaches the gastro-jejunal anastomosis. This would minimize bile reflux in comparison to the historical series of Billroth II reconstruction after gastrectomy for oncological or peptic disease (in which the biliopancreatic loop is much shorter, generally around 50 cm). Reported incidences of symptomatic bile reflux after OAGBP vary between 0.5% and 1.5%, comparable to our SAID-S results. It is worth mentioning that not all bile refluxes are symptomatic and that biliary gastritis is a premalignant condition. At present, there is a lack of literature on acid and bile reflux after bariatric surgery comparing the 3 digestive reconstruction techniques: (i) Roux-en-Y with pyloric preservation (DS), (ii) omega reconstruction with pyloric preservation or "Billroth II-like" (SADI-S) and (iii) omega reconstruction without pyloric preservations or Billroth II (OAGBP).

This prospective randomized study aims to compare conventional DS with SADI-S and OAGBP. We include all morbidly obese patients with BMI ≥ 50 kg/m2 and candidates to a directly DS following our treatment algorithm. Exclusion criteria are patients who do not fulfill our preoperative bariatric assessment for surgery and those with contraindications for hypo absorptive or mixed surgery.

The main objective of the investigation is to compare the percentage of excess weight lost at 2 and 5 years after the three different surgical procedures. For the study of weight evolution, both Dietetics' and General Surgery's postoperative standardized routine controls at our outpatient centre will be used.

As a secondary objective, gastroesophageal reflux (GER) will be compared before and 2 years after surgery. A GER's symptoms test, gastroscopy and a esophageal pH-impedance analysis in selected patients will be employed. Other secondary objectives include the comparison of short-term complications, metabolic comorbidities, bowel habit and quality of life two years after the surgical procedure. Furthermore, a medium and long term follow up on metabolic and nutritional deficiency will be performed.

For the morbidity and mortality analysis, the patients' electronic medical history records will be revised. Short postoperative complications (up to 30th postoperative day) will be classified according to Clavien-Dindo classification. Comorbidities' evolution will be evaluated following our centre follow-up protocol before and annually after the surgery. Data will be collected in a prospective database. The quality-of-life study will be carried out with the SF-12 test. The metabolic and nutritional deficit analysis will be carried out through the annual analytical data collected during the follow-up of the patients according to common clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 and younger than 65 who fulfil bariatric surgery indications
* BMI between 50 and 60 kg / m2
* Patients with a good overall condition to perform a one step surgery
* Signing up of the informed consent for the study
* Patient suitable for laparoscopic surgery

Exclusion Criteria:

* Previous bariatric surgery
* Two stage surgery
* Medical contraindication for a hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, organ transplantation or candidate for a transplant, previous intestinal resection surgery
* Conversion to laparotomy

Primary outcomes:
measure: Percentage of excess weight lost (% EWL)
timeFrame: At 5 years after surgery
Secondary outcomes:
measure: Gastroesophageal reflux
timeFrame: 2 years after surgery
measure: Postoperative complications
timeFrame: 30 days after surgery
measure: Postoperative mortality
timeFrame: 90 days after surgery
measure: Metabolic comorbidities
timeFrame: At 5 years of surgery
measure: Quality of life (SF-12 test)
timeFrame: At 2 years of surgery
measure: Depositional habit
timeFrame: At 2 years of surgery
measure: Need of revisional surgery
timeFrame: At 5 years of surgery
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitary de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Javier Osorio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finno P, Osorio J, Garcia-Ruiz-de-Gordejuela A, Casajoana A, Sorribas M, Admella V, Serrano M, Marchesini JB, Ramos AC, Pujol-Gebelli J. Single Versus Double-Anastomosis Duodenal Switch: Single-Site Comparative Cohort Study in 440 Consecutive Patients. Obes Surg. 2020 Sep;30(9):3309-3316. doi: 10.1007/s11695-020-04566-5.
citation: Sorribas M, Casajoana A, Sobrino L, Admella V, Osorio J, Pujol-Gebelli J. Experience in biliopancreatic diversion with duodenal switch: results at 2, 5 and 10 years. Cir Esp (Engl Ed). 2021 Feb 13:S0009-739X(21)00030-0. doi: 10.1016/j.ciresp.2021.01.008. Online ahead of print. English, Spanish.
citation: Admella V, Osorio J, Sorribas M, Sobrino L, Casajoana A, Pujol-Gebelli J. Direct and two-step single anastomosis duodenal switch (SADI-S): Unicentric comparative analysis of 232 cases. Cir Esp (Engl Ed). 2021 Aug-Sep;99(7):514-520. doi: 10.1016/j.cireng.2021.06.017. Epub 2021 Jul 1.