Evaluation Of Short-Term (30 Days) Surgical Outcomes Of Laparoscopic Heart burn Surgery : A Multicentre Prospective Observational Study In India
Not Applicable
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
- Registration Number
- CTRI/2024/03/063921
- Lead Sponsor
- Bangalore Endoscopic Surgery Training and Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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