Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGeneral Committee of Teaching Hospitals and Institutes, Egypt

About this trial

Obesity remains a major global health challenge, with rising prevalence and significant metabolic, cardiovascular, and gastrointestinal comorbidities. Laparoscopic sleeve gastrectomy (LSG) has emerged as the most widely performed bariatric procedure due to its technical simplicity and satisfactory short- to mid-term results. However, a proportion of patients experience suboptimal weight loss, recurrent weight gain, or both.

In this study, patients with recurrent weight gain of maximum weight loss or suboptimal weight loss or both following sleeve gastrectomy were included.

Suboptimal weight loss is defined as total weight loss (TWL) of less than 20% of the preoperative weight and/or excess weight loss (EWL) of less than 50%, measured at least 12-18 months after the primary sleeve gastrectomy.

Recurrent weight gain after sleeve gastrectomy is defined as an increase of ≥20% of the maximum weight loss (from nadir weight) or an increase in BMI of \>5, measured at least 24 months after the primary procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-65 years.

Patients who experienced recurrent weight gain, suboptimal weight loss, or both within 12-24 months or more following sleeve gastrectomy.

Eligible and fit for bariatric surgery.

Willing to provide informed consent and adhere to follow-up.

Disqualifiers

Severe psychiatric disorders or uncontrolled substance abuse.

Pregnancy or planned pregnancy within 2 years post-surgery.

Chronic steroid use or immunosuppressive therapy.

Active malignancy or history of gastrointestinal cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard revisional RYGB

    Procedure/Surgery

    * Small gastric pouch (\~30 mL). * 100-150 cm alimentary limb, 50 cm biliopancreatic limb.

  • Revisional Banded RYGB

    Procedure/Surgery

    * Standard RYGB as above. * Placement of a silastic ring (5.5-7.0 cm circumference) around the gastric pouch, \~2 cm above the gastrojejunal anastomosis.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Group non bandedActive comparator 1 intervention
Group B: Group bandedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent EWL (excess weight loss) and percent TWL (Total weight loss)

relative to both the pre-primary surgery (sleeve gastrectomy) weight and the pre-revisional surgery (RYGB or ringed RYGB) weight by kilograms.

Time frame
1, 2, 3, 4, and 5 years postoperatively

Secondary outcomes

1

Comorbidity resolution

T2DM (type 2 diabetes mellitus) Clinical Remission Criteria (T2DM) The American Diabetes Association (ADA) and other international experts define remission based on glycemic levels in the absence of glucose-lowering medications for at least 3 to 12 months. Complete Remission: HbA1c \< 5.7% and Fasting Plasma Glucose (FPG) \< 100 mg/dL. Partial Remission: HbA1c between 5.7% and 6.4% and FPG between 100-125 mg/dL. Improvement: A significant reduction in HbA1c (\>1%) or FPG (\>25 mg/dL), or a substantial decrease in medication dosage (e.g., stopping insulin) without meeting full remission criteria.

Time frame
6 months, 1,2,3,4 and 5 years postoperatively
2

Comorbidity resolution

HTN (hypertension) Comparing pre- and postoperative results for hypertension (HTN) involves tracking clinical benchmarks that measure both blood pressure (BP) levels and the intensity of medical therapy required for control. Clinical Metrics for Comparison Blood Pressure Readings: Comparison of mean systolic and diastolic BP. Preoperative levels (typically around 140/90 mmHg) are compared against postoperative follow-up intervals. Medication Load: Tracking the total number of antihypertensive agents (AHMs). A common outcome is the likelihood of complete AHM discontinuation, which is significantly higher (around 32%) in surgical patients. Resolution vs. Improvement: Resolution: Often defined as achieving a BP \<140/90 mmHg (or \<130/80 mmHg per some AHA guidelines) while being off all medications. Improvement: Defined as a ≥30% reduction in antihypertensive medications while maintaining controlled BP.

Time frame
6 months, 1,2,3,4 and 5 years postoperatively
3

Comorbidity resolution

OSA (obstructive sleep apnea) The most reliable way to compare status is through a follow-up polysomnography or home sleep test. Apnea-Hypopnea Index (AHI): This is the primary metric. It measures the number of pauses in breathing per hour of sleep. Cure/Resolution: Defined as an AHI \< 5. Improvement: Often defined as an AHI reduction of at least 50% or reaching a threshold of AHI \< 15. Oxygen Desaturation Index (ODI): Measures the number of times blood oxygen levels drop significantly per hour. Bariatric surgery typically leads to a marked decrease in this index. Mean and Nadir SpO2: Comparison of average and lowest oxygen saturation levels during sleep, which generally increase after surgery. Treatment Requirements CPAP Pressure: For patients who still require treatment, the required therapeutic pressure (measured in cmH2O or mbar) typically decreases post-operatively. Discontinuation Rate: A common comparison point is the percentage of patients who can stop using CPAP entirely.

Time frame
6 months, 1,2,3,4 and 5 years postoperatively
4

Quality of Life (SF-36)

Quality of Life (QoL) scores typically show dramatic initial improvements, particularly in physical domains, followed by a stabilization or gradual decline over the long term. The Short Form-36 (SF-36) questionnaire measures eight health domains on a scale of 0 (lowest) to 100 (highest): Physical Component Summary (PCS): Includes Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), and General Health (GH). Mental Component Summary (MCS): Includes Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Typical Score Trends Pre-Surgery (Baseline): Patients often start with global QoL scores around 45.6 to 48.3. Physical component scores are typically significantly lower than population norms. 1 Year Post-Surgery: Global scores often peak, reaching approximately 79.7. Both PCS and MCS frequently return to or exceed general population norms (typically around 50 for summary scores) during this period.

Time frame
1, 2, 3, 4, and 5 years postoperatively

Other outcomes

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