SAPI vs SASI in the Management of Morbid Obesity

NCT07618598 | Completed

• 1 other identifier: MD.21.03.433
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design A single-center cohort study combining prospective and retrospective data collection was conducted. The prospective arm enrolled consecutively admitted patients, while the retrospective arm analyzed previously recorded cases meeting identical eligibility criteria. Study Setting and Population The study was performed at the General Surgery Department, Faculty of Medicine, Mansoura University. It included adults aged 18-65 years with morbid obesity eligible for bariatric surgery:

• Body mass index (BMI) ≥ 35 kg/m² with obesity-related comorbidities, or
• BMI 30-34.9 kg/m² with at least one major comorbidity \[e.g., type 2 diabetes mellitus (T2DM), hypertension (HTN), obstructive sleep apnea (OSA), dyslipidemia, osteoarthritis (OA), and gastroesophageal reflux disease (GERD)\] Study Period
• Prospective: September 2021 - September 2023
• Retrospective: January 2017 - August 2021 Eligibility Criteria Included patients were American Society of Anesthesiology (ASA) class I-III and had failed structured non-surgical weight management for ≥6 months. Exclusion criteria included endocrine obesity, prior bariatric surgery, severe psychiatric or cognitive disorders, substance abuse, pregnancy, and previous major upper abdominal surgery. Sample Size Sample size was calculated based on cost difference between SASI and SAPI procedures using a two-sample means formula. A clinically relevant difference of 500 USD and SD of 700 USD were assumed, yielding:
• Total of 62 patients in the entire cohort
• Adjusted for 10% attrition → 70 total patients Final allocation was approximately 2:1 single anastomosis sleeve ileal bypass (SASI) : single anastomosis plication ileal bypass (SAPI), reflecting real-world recruitment rather than randomization. Group Allocation Non-randomized assignment was used. Prospective allocation involved shared decision-making within a multidisciplinary team, while retrospective allocation was based on prior surgical records. Influencing factors included cost, availability, insurance, and patient preference. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Methods Preoperative Assessment Comprehensive evaluation included:
• Detailed medical history and comorbidity assessment
• Nutritional deficiency screening and correction
• Anthropometric measurements
• Laboratory tests
• Imaging (as indicated) Validated Questionnaires
• Physical activity: using The Rapid Assessment of Physical Activity (RAPA)
• Eating behavior: Self-Regulation of Eating Behavior Questionnaire (SREB-Q) and The Eating Attitudes Test (EAT-26)
• Sleep quality: The Pittsburgh Sleep Quality Index (PSQI)
• Socioeconomic status: Fahmy \& El-Sherbini scale
• Quality of life (QoL): The Moorehead-Ardelt Quality of Life Questionnaire II (MA-QoL II) Surgical Procedures Two laparoscopic techniques were performed: SASI
• Sleeve gastrectomy over 36-Fr bougie
• 300 cm ileal loop anastomosed to gastric antrum
• Stapled side-to-side stapled gastroileal anastomosis SAPI
• Same, but gastric devascularization and plication over a 36-Fr bougie rather than sleeve gastrectomy Both procedures included leak testing, drain placement, and dual-outlet gastric configuration. Postoperative Management Standardized enhanced recovery protocol:
• Early mobilization and VTE prophylaxis
• Proton pump inhibitors and analgesia
• Gradual oral intake from postoperative day 1
• Imaging and lab assessment when indicated
• Early discharge if stable Cost Analysis A micro-costing approach was used, including:
• Primary costs: technology, personnel, instruments, disposables, hospitalization, follow-up, supplements
• Secondary costs: readmissions and re-interventions Cost components were calculated using standardized formulas for each item Total cost = Primary + Secondary costs Cost-effectiveness was evaluated using:
• Cost-effectiveness ratios (CER)
• Incremental cost-effectiveness ratio (ICER)
• Outcomes included percentage of excess weight loss (%EWL), complication rates, readmission, comorbidity remission, and The Bariatric Analysis and Reporting Outcome System (BAROS). Follow-Up and Outcomes Follow-up included:
• Weekly (1st month), biweekly (next 2 months), then quarterly (up to 1 year)
• Assessment of weight loss, comorbidities, complications, and QoL Primary outcome:
• Total cost difference between SASI and SAPI Secondary outcomes:
• Operative time, length of hospital stay, complications
• %EWL, comorbidity remission
• QoL (MA-QoL II, BAROS) Statistical Analysis Performed using SPSS v26:
• Normality: Shapiro-Wilk test
• Continuous data: t-test or Mann-Whitney U
• Categorical data: Chi-square or Fisher's test
• Regression: linear and logistic models
• Significance set at p \< 0.05.

Conditions

Morbid Obesity Requiring Bariatric Surgery

Keywords

Bariatric surgery; SASI (Single Anastomosis Sleeve Ileal bypass); SAPI (Single Anastomosis Proximal Ileal bypass); Cost-effectiveness analysis; Micro-costing; Metabolic surgery; Obesity surgery outcomes; Excess weight loss; Comorbidity remission; Quality of life; BAROS score; Morbid obesity; Comparative cohort study

Outcome Measures

Primary Outcomes (1)

• Total Cost of Surgical Management (SASI vs SAPI)

  Comparison of the total economic burden associated with SASI and SAPI procedures, including all direct medical costs from index admission and subsequent follow-up.

  Up to 12 months postoperatively

Secondary Outcomes (9)

• Operative Time

  Intraoperative

• Length of Hospital Stay (LOS)

  From surgery to discharge (up to 30 days)

• Postoperative Complications

  Up to 12 months postoperatively

• Percentage of Excess Weight Loss (%EWL)

  Baseline, 6 months, 12 months

• Body Mass Index (BMI)

  Baseline, 6 months, 12 months

Study Arms (2)

SASI Procedure Group

ACTIVE COMPARATOR

Patients undergo sleeve gastrectomy combined with omega-loop ileal anastomosis (300 cm from ileocecal valve), according to standardized surgical protocol

Procedure: Single Anastomosis Sleeve Ileal (SASI) Bypass Procedure

SAPI Procedure Group

ACTIVE COMPARATOR

Patients undergo gastric plication with omega-loop ileal anastomosis (300 cm from ileocecal valve), following standardized technique

Procedure: Single Anastomosis Plication Ileal (SAPI) Bypass Procedure

Interventions

Single Anastomosis Sleeve Ileal (SASI) Bypass Procedure PROCEDURE

Participants undergo laparoscopic SASI bariatric surgery consisting of sleeve gastrectomy followed by a single omega-loop gastroileal anastomosis. An isoperistaltic ileal limb is measured 300 cm proximal to the ileocecal valve. A stapled side-to-side gastroileal anastomosis is created, and the staple entry site is closed with barbed sutures. Standard leak testing and drain placement are performed.

SASI Procedure Group

Single Anastomosis Plication Ileal (SAPI) Bypass Procedure PROCEDURE

Participants undergo laparoscopic SAPI bariatric surgery involving gastric plication followed by a single omega-loop gastroileal anastomosis. An isoperistaltic ileal limb is measured 300 cm from the ileocecal valve. A stapled side-to-side anastomosis is performed between the gastric antrum and ileal loop, with closure of the enterotomy using barbed sutures. Leak testing and drain placement are routinely performed.

SAPI Procedure Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Classified as American Society of Anesthesiologists (ASA) physical status I-III
• Diagnosed with morbid obesity
• Failure to achieve or maintain clinically significant weight loss after ≥6 months of structured, supervised non-surgical weight management
• Participation in a supervised program including dietary modification, behavioral counseling, and lifestyle interventions

You may not qualify if:

• Obesity secondary to endocrine disorders (e.g., Cushing's syndrome)
• Previous bariatric or metabolic surgery
• Significant cognitive impairment affecting consent or follow-up
• Major psychiatric illness interfering with adherence or postoperative care
• Active substance abuse or alcoholism
• Pregnancy at enrollment or planned pregnancy within 12 months
• Previous major upper abdominal laparotomy affecting surgical anatomy or increasing operative risk
• Poor motivation or unwillingness to comply with long-term lifestyle modification and follow-up

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: September 11, 2021
• Primary Completion: July 11, 2024
• Study Completion: March 15, 2025
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data (IPD) and supporting study documents will be made available upon reasonable request after publication of the primary study results. Data sharing will commence within 6 months following publication and will remain available for a period of up to 5 years thereafter. Access will be granted for scientifically valid proposals and subject to institutional and ethical approval, as well as the execution of a data-sharing agreement to ensure confidentiality and compliance with data protection regulations.
• Access Criteria: Access to individual participant data (IPD) and supporting study materials will be granted to qualified researchers who submit a scientifically sound proposal and whose request is approved by the corresponding author and relevant institutional/ethical review bodies. Access will be limited to de-identified data only, along with available supporting documents such as the study protocol and statistical analysis plan, where applicable. Data will be shared for non-commercial research purposes only, under a formal data-sharing agreement to ensure confidentiality, data protection, and appropriate use. Requests should be submitted to the corresponding author via email and will be evaluated on a case-by-case basis.

Locations

EG (1)