To compare the results of two surgical techniques (Polymeric clip versus Endoscopic stapler) used to close the base of appendix in patients with appendix infection needing operatio
Phase 2
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/09/036627
- Lead Sponsor
- AIIMS NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. 18 to 65 years of age, both genders,
2. Acute appendicitis (mild to moderate inflammation), Appendicolith, Appendicular perforation
3. Appendicular base diameter is not more than 11 mm
4. Willing to participate in the study and follow-up
Exclusion Criteria
1. Less than 18 years and more than 65 years of age
2. Open surgery
3. Technically not feasible due to following reason at the base of the appendix (BOA):
a. Rupture or perforation at BOA
b. Oedematous, friable or inflamed BOA: application of stapler or Hem-o-Lok would cut through the tissue
4. Appendicular abscess, intra-abdominal abscess
5. Appendicular mass
6. Primary Pathology other than appendicitis
7. Inability to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Appendiceal stump dehiscence and post-operative complications <br/ ><br>2. Cost-effectiveness [cost of treatment from surgery to discharge] <br/ ><br>Timepoint: 1. One month <br/ ><br>2. One month
- Secondary Outcome Measures
Name Time Method 1. Ease of application and time required for application [from introduction of applicator to cutting the base of appendix] <br/ ><br>2. Total operative time: in minutes <br/ ><br>3. Total operative charges <br/ ><br>4. Total hospital charges <br/ ><br>5. Length of hospital stay: up to 30 days <br/ ><br>6. Surgical Site Infection: up to 30 days <br/ ><br>7. Intervention or re-surgery: <br/ ><br>8. Adhesive intestinal obstruction <br/ ><br>9. Post-operative collection.Timepoint: 1. Immediate <br/ ><br>2. Minutes <br/ ><br>3. In rupees <br/ ><br>4. In rupees <br/ ><br>5. One to thirty days <br/ ><br>6. One to thirty days <br/ ><br>7. One to thirty days <br/ ><br>8. One to thirty days <br/ ><br>9. Millilitre