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Evaluation Of Short-Term (30 Days) Surgical Outcomes Of Laparoscopic Heart burn Surgery : A Multicentre Prospective Observational Study In India

Evaluation Of Short-Term (30 Days) Surgical Outcomes Of Laparoscopic Anti-Reflux Surgery : A Multicentre Prospective Observational Cohort Study In India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/063921
Enrollment
100
Registered
2024-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis

Interventions

Intervention1: NIL: NIL

Sponsors

Bangalore Endoscopic Surgery Training and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older. 2. Patients undergoing elective Anti-Reflux Surgery. 3. Both primary and recurrent/ complex hiatus hernia without complications. 4. Willingness to participate, as evidenced by signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient not willing to give informed consent 2. Revisional Anti-Reflux Surgery. 3. Emergency Hiatal Hernia Surgery. 4. Incidental Hiatal Surgery (for example crural repair with bariatric surgery) 5. Pregnancy 6. Untreated Oesophageal Motility Disorders 7. Patients with severe medical conditions and multiple comorbidities.

Design outcomes

Primary

MeasureTime frame
The primary end point of this study is to evaluate the 30-day morbidity following laparoscopic hiatus hernia repair, as assessed by the Clavien-Dindo Grade. This grading system is a standardized method for classifying surgical complications and provides a comprehensive framework for evaluating the severity and impact of postoperative complications. The 30-day timeframe is chosen to focus on short-term outcomes, which are critical for assessing the immediate success and safety of the surgical procedure. The Clavien-Dindo Grade will be used to categorize complications into different grades, ranging from Grade I (minor complications requiring no treatment) to Grade V (death).Timepoint: At the end of 3 months and 6 months

Secondary

MeasureTime frame
Duration of procedure, length of stay, procedure specific complication rates such as bleeding, bowel injury, pneumothorax, solid organ injury and reoperation ratesTimepoint: Same as above

Countries

India

Contacts

Public ContactDr Ramesh Makam

BEST Institute

drramesh@hotmail.com9845006123

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026