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NCT Number: NCT05608772

Conversion to SADI-S, RYGB or OAGB After Failed Sleeve

Assess what revisional surgery is superior and provides the best weight loss after primary LSG. What is the occurrence of complications and the nutritional laboratory status? And if the resolution and /or improvement of associated medical problems after the weight loss will occur.

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Key information

Conditions

Weight Loss Bariatric Surgery Candidate Body Weight Body Weight Changes Comorbidities and Coexisting Conditions Nutrient Deficiency Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madina Women's Hospital

Alexandria, Alexandria Governorate, 21531, Egypt

Location status: Recruiting

Location contact

Mohamed Ashour, PhD

CONTACT

[email protected]

00201002600970

About this study

Laparoscopic sleeve gastrectomy (LSG) gained popularity and has become one of the most performed weight loss procedures worldwide. In the long-term follow-up, the literature states that the incidence of gastroesophageal reflux disease (GERD) accounts for 16%, and weight regains accounting for 70% after LSG. These are the two most common complications which can necessitate further surgical intervention.

The hypotheses are that laparoscopic conversion from LSG to Single anastomosis duodeno-ileal bypass (SADI-S), Roux-en-Y gastric bypass (RYGB), or one anastomosis gastric bypass (OAGB) will provide a new significant weight loss, improvement in obesity-related health problems and provide no nutritional deficiency in all cases.

Since the three types of procedures have other anatomical presentations, whereby these is not well tested next to each other in a blinded, controlled setting for the patient, this study is designed to discover if the procedures are superior to each other or not and what the best outcome is for the patient.

A sample size is calculated and with a medium effect size of 0.5 corresponds to a mean difference in %EBMIL between SADI-S, RYGB, and OAGB of at least 10%. Using a power of 0.8 with an alpha of 0.05 resulted in a sample size of 64 patients per group.

Considering a possible loss of patients to follow-up, an additional 20% increase in sample size was included per group, resulting in a minimum of 78 patients per group.

(Total of 3 groups together of 234 patients).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergone primary laparoscopic sleeve gastrectomy in the past
  • Weight regain
  • defined as any increase in weight above the nadir as reported by the patient
  • BMI at the time of revisional surgery was around 45 kg/m2
  • weight regain was defined as an increase in BMI after bariatric surgery to exceed 35
  • With or without Gastroesophageal reflux disease (GERD) grade A and B o Patients with grade C or higher GERD, according to the Los Angeles (LA) classification [7] will be excluded from the study

Exclusion criteria

  • Didn't follow preoperative consultation
  • Cannot give of sign informed consent

Treatment and study plan

revision surgery

Procedure

revision procedure after failed sleeve gastrectomy

Primary outcomes

  1. The number of participants who will have early complications related to surgery

    Time frame: 6 weeks

    the incidence of re-operation, bleeding or leakages

  2. The percentage Excess body weight loss (%EWL)

    Time frame: 3,6,12,24 months

    the amount of weight loss after revision surgery

  3. somscore of food tolerance

    Time frame: 2,6 weeks and 3,6,12,24 months

    validated food tolerance questions: Food tolerance (FT) was evaluated using a one-page questionnaire divided into 4 sections, 3 of which were used to calculate the score: overall patient satisfaction with eating (score: 1-5); tolerability to certain food types (score: 0-16); and frequency of vomiting/regurgitation (score: 0-6), with a total score between 1 and 27; higher scores indicate better food tolerance

Secondary outcomes

  1. Nutritional levels of albuminemia

    Time frame: 3,6,12,24 months

    the albuminemia level will be tested after surgery (g/dl)

  2. Nutritional levels of proteinemia

    Time frame: 3,6,12,24 months

    the proteinemia level will be tested after surgery (mg/dl)

  3. Nutritional levels of anemia

    Time frame: 3,6,12,24 months

    the anemia level will be tested after surgery (Mcl)

  4. Nutritional levels of calcemic

    Time frame: 3,6,12,24 months

    the calcemic level will be tested after surgery (mg/dl)

  5. Incidence of Reflux

    Time frame: 3,6,12,24 months

    GERD assessment

  6. The number of participants who will have late complications related to surgery

    Time frame: 3,6,12,24 months

    the incidence of re-operations will be collected

  7. Short Form 36 Quality of life

    Time frame: 3,6,12,24 months

    Quality of life assessment will be tested 8 chapters with in total 36 questions and a somscore from 0-100 will be calculated (the higher the somscore the better the quality of life is).

  8. VAS/NRS (incidence of pain)

    Time frame: 3,6,12,24 months

    pain scoring from 0-10 (0 is no pain 10 is most worst pain)

  9. Metabolic biomarkers Glucagon-like peptide-1 (GLP1)

    Time frame: 3,6,12,24 months

    the GLP1 level will be tested after surgery (mg/ml)

  10. Metabolic biomarkers Leptin

    Time frame: 3,6,12,24 months

    the Leptin level will be tested after surgery (mg/ml)

  11. Metabolic biomarkers Peptide YY ( PYY)

    Time frame: 3,6,12,24 months

    the PYY level will be tested after surgery (pg/ml)

  12. Metabolic biomarkers Ghrelin

    Time frame: 3,6,12,24 months

    the Ghrelin level will be tested after surgery (mg/ml)

  13. Metabolic biomarkers Insulin

    Time frame: 3,6,12,24 months

    the Insulin level will be tested after surgery (million units/ml)

Other outcomes

  1. The number of participants who will have late complications related to surgery

    Time frame: 60 months

    the incidence of re-operations or complications will be collected

  2. The number of participants whereby revision surgery necessary after the RCT

    Time frame: 60 months

    the incidence of re-operations or other procedure will be collected

  3. The percentage Excess body weight loss (%EWL)

    Time frame: 60 months

    the amount of weight loss after revision surgery

  4. Incidence of Reflux

    Time frame: 60 months

    GERD classification

  5. Nutritional levels of albuminemia

    Time frame: 60 months

    the albuminemia level will be tested after surgery (g/dl)

  6. Nutritional levels of proteinemia

    Time frame: 60 months

    the proteinemia level will be tested after surgery (mg/dl)

  7. Nutritional levels of anemia

    Time frame: 60 months

    the anemia level will be tested after surgery (Mcl)

  8. Nutritional levels of calcemic

    Time frame: 60 months

    the calcemic level will be tested after surgery (mg/dl)

  9. Somscore of food tolerance

    Time frame: 60 months

    validated food tolerance questions: Food tolerance (FT) was evaluated using a one-page questionnaire divided into 4 sections, 3 of which were used to calculate the score: overall patient satisfaction with eating (score: 1-5); tolerability to certain food types (score: 0-16); and frequency of vomiting/regurgitation (score: 0-6), with a total score between 1 and 27; higher scores indicate better food tolerance

  10. Short Form 36 Quality of life

    Time frame: 60 months

    Quality of life assessment will be tested 8 chapters with in total 36 questions and a somscore from 0-100 will be calculated (the higher the somscore the better the quality of life is).

  11. VAS/NRS (incidence of pain)

    Time frame: 60 months

    pain scoring from 0-10 (0 is no pain 10 is most worst pain)

  12. Metabolic biomarkers Glucagon-like peptide-1 (GLP1)

    Time frame: 60 months

    the GLP1 level will be tested after surgery (mg/ml)

  13. Metabolic biomarkers Leptin

    Time frame: 60 months

    the Leptin level will be tested after surgery (mg/ml)

  14. Metabolic biomarkers Peptide YY ( PYY)

    Time frame: 60 months

    the PYY level will be tested after surgery (pg/ml)

  15. Metabolic biomarkers Ghrelin

    Time frame: 60 months

    the Ghrelin level will be tested after surgery (mg/ml)

  16. Metabolic biomarkers Insulin

    Time frame: 60 months

    the Insulin level will be tested after surgery (million units/ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Bart Torensma, PHD

CONTACT

[email protected]

+31641389070

Mohamed Ashour, MD

CONTACT

[email protected]

+201002600970

Sponsors and collaborators

Lead sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Other Gov

Registry information

Official study title

Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB

Acronym: RCTresleeve

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 8, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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