Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy For Morbidly Obese Patients

NCT ID: NCT04218045

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-05-01

Brief Summary

Evaluation of the advantages, disadvantages and complications of a recently innovated procedure (Single anastomosis sleeve ileal "SASI" bypass) of the more traditional laparoscopic sleeve gastrectomy "LSG"

Detailed Description

Obesity is a major health problem affecting over 1.7 billion people. Obesity is defined as excess body weight due to abnormal or excessive fat accumulation that presents a risk to health. A crude popular measure of obesity is the body mass index (BMI), a person's weight (in kilograms) divided by the square of his or her height (in meters). A person with a BMI of 30 or more is generally considered obese. A person with a BMI equal to or more than 25 is considered overweight.

Obesity is a major risk factor for a number of chronic diseases, including diabetes mellitus, cardiovascular diseases and cancer. It is associated with significant co-morbid conditions and reduced life expectancy. Since 1997, obesity has been officially recognized by the World Health Organization as a global epidemic.

Bariatric surgery has been shown to be the most successful approach in managing morbid obesity that can achieve and sustain great weight loss for a long period.

Common strategies of bariatric surgery are: mechanical obstacles to food ingestion, nutrient-excluded segments and malabsorption, which are a potential cause for complications and should better be avoided from a strictly physiological prospect. Also, such procedures necessitate lifelong medical supervision with the supplementation of vitamins and nutrients. Moreover, they are frequently associated with dysphagia and vomiting as a result of anatomical restrictions.

Laparoscopic sleeve gastrectomy (LSG) was initially established as the first stage of a two stage bariatric approach. It is now used as a primary bariatric procedure because of documented excellent weight loss and an acceptable risk of complication. Advantages include the avoidance of implantable material, maintenance of gastrointestinal continuity, avoidance of malabsorption, and convertibility to other operations. However, The major disadvantage of LSG is the severity of the major postoperative complications like bleeding and staple-line leakage. Staple-line disruption is the most life-threatening complication after LSG, Leaks after sleeve gastrectomy (SG) mostly occur because of the creation of a high internal pressure pouch.

Our understanding of digestive physiology is now changing and the interacting neuroendocrine signals that control hunger, satiety, and energy expenditure are better understood now. The role of GI tract in satiety is a sum of a mechanical sensation of a full stomach, rapidly confirmed by neuroendocrine signals that recognize whether the ingested was indeed nutritive. In terms of meal termination, the most important of these postprandial neuroendocrine signals are an elevation of satiety gut hormones in the blood, such as Glucagon-Like peptide 1 (GLP-1) and Peptide Tyrosine Tyrosine (PYY) and a reduction of ghrelin, an orexigenic hormone mainly produced by neuroendocrine cells mostly located in the gastric fundus. Recent physiological knowledge allows the design of bariatric procedures that aim at neuroendocrine changes instead of mechanical restriction and malabsorption.

"Santoro" have recently reported his long-term data regarding sleeve gastrectomy with transit bipartition (SG þ TB), which is a similar operation to duodenal switch (DS) but without complete exclusion of duodenum in order to minimize nutritional complications. The goal of this operation was to benefit the patients by counterbalancing the harmful effects of the modern diet. Without exclusions and with a simple surgical procedure, SG þ TB amplifies the nutritive stimulation of the distal gut whereas simultaneously diminishing the exposure of the proximal bowel to nutrients without completely deactivating duodenum and jejunum.

A Modification of Santoro's operation was first reported as a case report by Mui in 2013, then as a Case series on 68 patients by Greco and Tacchino in 2014 by performing a loop rather than Roux-en-Y bipartition reconstruction, which came to be known as (Single Anastomosis Sleeve Ileal "SASI") bypass.

That procedure has the advantage of maintaining the natural pathway through the duodenum where a small percentage of food passes, and is associated with minimal post-operative nutritional complications, and allows for full visualization of the biliary system during endoscopy. Moreover, it's suggested that the incidence of leakage and gastroesophageal reflux after sleeve gastrectomy is significantly reduced by the gastroileal bypass due to the decrease in stomach pouch pressure.

This study aims to evaluate SASI bypass as a mode of functional restrictive therapeutic option for morbidly obese patients, versus LSG.

Conditions

Bariatric Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic sleeve gastrectomy group

The group of morbidly obese patients undergoing laparoscopic sleeve gastrectomy

Group Type: ACTIVE_COMPARATOR

Laparoscopic sleeve gastrectomy

Intervention Type: PROCEDURE

Conventional sleeve gastrectomy using endoscopic stapler

SASI bypass group

The group of morbidly obese patients undergoing laparoscopic single- anastomosis sleeve ileal bypass (the new procedure being evaluated)

Group Type: EXPERIMENTAL

Laparoscopic single anastomosis sleeve ileal bypass

Intervention Type: PROCEDURE

a simple loop gastro-ileal bypass is added to the sleeve procedure.

Interventions

Laparoscopic single anastomosis sleeve ileal bypass

a simple loop gastro-ileal bypass is added to the sleeve procedure.

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy

Conventional sleeve gastrectomy using endoscopic stapler

Intervention Type: PROCEDURE

Other Intervention Names

SASI bypass - Santoro's operation - sleeve gastrectomy with transit bipartite - SG þ TB

Eligibility Criteria

Inclusion Criteria

• Morbid Obesity (BMI ≥ 40 kg/m2) or ( ≥ 35 kg/m2 with associated co-morbidity e.g. type 2 diabetes, joint problems …)
• Age ≥ 18 and < 60
• Failure to achieve adequate and consistent weight loss for at least one year while being followed up by a dietitian.

Exclusion Criteria

• Patients BMI < 35kg/m2
• Patients who managed to achieve consistent weight loss by diet control.
• Contra-indications to laparoscopic surgery e.g. intolerance to general anesthesia, coagulopathy or an associated condition that requires laparotomy.
• Contra-indications to gastrectomy e.g. gastric ulcer, hiatal hernia or gastro-esophageal reflux disease.
• Previous laparotomy or bariatric procedure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

yousef ahmed el-ayman

assistant lecturer of general surgery, Master degree, MD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig University

Zagazig, Elsharkia, Egypt

Countries

Egypt

References

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Reference Type: BACKGROUND

PMID: 16652128 (View on PubMed)

Herron DM. The surgical management of severe obesity. Mt Sinai J Med. 2004 Jan;71(1):63-71.

Reference Type: BACKGROUND

PMID: 14770252 (View on PubMed)

Santoro S, Milleo FQ, Malzoni CE, Klajner S, Borges PC, Santo MA, Campos FG, Artoni RF. Enterohormonal changes after digestive adaptation: five-year results of a surgical proposal to treat obesity and associated diseases. Obes Surg. 2008 Jan;18(1):17-26. doi: 10.1007/s11695-007-9371-0. Epub 2007 Dec 15.

Reference Type: BACKGROUND

PMID: 18080721 (View on PubMed)

Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):469-75. doi: 10.1016/j.soard.2009.05.011. Epub 2009 Jun 9. No abstract available.

Reference Type: BACKGROUND

PMID: 19632646 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15677821 (View on PubMed)

Drazen DL, Woods SC. Peripheral signals in the control of satiety and hunger. Curr Opin Clin Nutr Metab Care. 2003 Nov;6(6):621-9. doi: 10.1097/00075197-200311000-00003.

Reference Type: BACKGROUND

PMID: 14557791 (View on PubMed)

Casella G, Soricelli E, Rizzello M, Trentino P, Fiocca F, Fantini A, Salvatori FM, Basso N. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Jul;19(7):821-6. doi: 10.1007/s11695-009-9840-8. Epub 2009 Apr 21.

Reference Type: BACKGROUND

PMID: 19381737 (View on PubMed)

Mui WL, Lee DW, Lam KK. Laparoscopic sleeve gastrectomy with loop bipartition: A novel metabolic operation in treating obese type II diabetes mellitus. Int J Surg Case Rep. 2014;5(2):56-8. doi: 10.1016/j.ijscr.2013.12.002. Epub 2013 Dec 10.

Reference Type: BACKGROUND

PMID: 24441436 (View on PubMed)

Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0.

Reference Type: BACKGROUND

PMID: 22609843 (View on PubMed)

Greco F, Tacchino R. Ileal food diversion: a simple, powerful and easily revisable and reversible single-anastomosis gastric bypass. Obes Surg. 2015 Apr;25(4):680-6. doi: 10.1007/s11695-014-1436-2.

Reference Type: BACKGROUND

PMID: 25236398 (View on PubMed)

Related Links

http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-31802006000400004&tlng=pt

Preliminary results from digestive adaptation: a new surgical proposal for treating obesity, based on physiology and evolution

https://link.springer.com/article/10.1007%2Fs11695-008-9520-0

Bariatric Surgery in Adolescents: Preliminary 1-year Results with a Novel Technique (Santoro III)

Other Identifiers

YousefMDThesis

Identifier Type: -

Identifier Source: org_study_id