One-Year Outcomes After Conversion Bariatric Surgery

NCT ID: NCT07345429

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-02-01

Brief Summary

Obesity is a growing global public health problem, and bariatric surgery is currently the most effective treatment for achieving sustained weight loss and improving obesity-related comorbidities. However, a subset of patients experience inadequate weight loss or weight regain following primary bariatric surgery, which may lead to the recurrence of metabolic complications and reduced quality of life. In such cases, conversion bariatric surgery, defined as the surgical conversion from one bariatric procedure to another, is considered an important therapeutic option. Despite the increasing number of conversion procedures, comprehensive longitudinal data evaluating anthropometric, biochemical, and nutritional outcomes after conversion bariatric surgery remain limited.

This study aims to prospectively evaluate individuals undergoing conversion bariatric surgery due to weight regain following primary bariatric surgery. Anthropometric measurements, biochemical parameters, and nutritional status will be assessed preoperatively and at 1 year after surgery. By evaluating weight loss outcomes together with metabolic and nutritional changes, this study seeks to provide clinically relevant evidence to guide postoperative follow-up strategies, optimize nutritional management, and support multidisciplinary care in patients undergoing conversion bariatric surgery.

Conditions

Obesity & Overweight; Bariatric Surgery; Revisional Bariatric Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Conversion Bariatric Surgery

This cohort includes patients who previously underwent conversion bariatric surgery as part of routine clinical care and were followed observationally. Anthropometric measurements, biochemical parameters, and nutritional status were assessed at the preoperative period and postoperative month 12 (1 year).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-45 years
• Previously underwent bariatric surgery
• Subsequently underwent conversion bariatric surgery due to suboptimal clinical response

Suboptimal clinical response defined as either:

• Suboptimal Clinical Response (SCR): maximum total weight loss (TWL%) of <20% within 18 months after metabolic and bariatric surgery
• Recurrent Weight Gain (RWG): regaining >30% of initial postoperative weight loss after achieving initial weight reduction

Exclusion Criteria

• Pregnancy or lactation
• Presence of acute illness or infection
• Comorbid conditions that could limit treatment efficacy or compromise safety
• Participation in professional athletic activity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mudanya University

OTHER

Sponsor Role: collaborator

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Seher Şen

Assistant Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seher Şen, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Mudanya University

Locations

Mudanya Univesity

Osmangazi, Bursa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MUDU-SBE-SS-01

Identifier Type: -

Identifier Source: org_study_id