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 operation

Polymeric Clip versus Endoscopic Stapler for securing base of appendix during laparoscopic appendectomy: An exploratory randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036627

Enrollment

Registered

2021-09-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group A: Polymeric Clips used for securing base of appendix Control Intervention1: Group B: Endoscopic stapler used for securing base of appendix

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Appendiceal stump dehiscence and post-operative complications 2. Cost-effectiveness [cost of treatment from surgery to discharge] Timepoint: 1. One month 2. One month	—

Secondary

Measure	Time frame
1. Ease of application and time required for application [from introduction of applicator to cutting the base of appendix] 2. Total operative time: in minutes 3. Total operative charges 4. Total hospital charges 5. Length of hospital stay: up to 30 days 6. Surgical Site Infection: up to 30 days 7. Intervention or re-surgery: 8. Adhesive intestinal obstruction 9. Post-operative collection.Timepoint: 1. Immediate 2. Minutes 3. In rupees 4. In rupees 5. One to thirty days 6. One to thirty days 7. One to thirty days 8. One to thirty days 9. Millilitre	—

Measure

Time frame

1. Ease of application and time required for application [from introduction of applicator to cutting the base of appendix] 2. Total operative time: in minutes 3. Total operative charges 4. Total hospital charges 5. Length of hospital stay: up to 30 days 6. Surgical Site Infection: up to 30 days 7. Intervention or re-surgery: 8. Adhesive intestinal obstruction 9. Post-operative collection.Timepoint: 1. Immediate 2. Minutes 3. In rupees 4. In rupees 5. One to thirty days 6. One to thirty days 7. One to thirty days 8. One to thirty days 9. Millilitre

—

Countries

India

Contacts

Public ContactRatnakar Namdeo

All India Institute of Medical Sciences New Delhi

ratnakarnamdeo@gmail.com9039434643

Outcome results

None listed

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