Comparative Effectiveness and safety of Hem-o-Lok® clips versus Endo loops for Appendicular stump closure in Laparoscopic Appendectomy: A randomized controlled trial in a Tertiary Care Center in Eastern Uttar Pradesh.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- The time required to close the appendicular stump and investigate the differences in post-operative complications, including surgical site infections and stump leaks, as well as the length of hospital stay and recovery times between the two closure techniques.
Study Overview
Brief Summary
During laparoscopic appendectomy, the appendiceal stump can be ligated and resected using various methods such as an endoloop, endostapler, or polymeric clip. While an endoloop may pose some challenges in handling, a polymeric clip offers the advantage of easy application. The safety of polymeric clips in this procedure is well-established,with several studies noting shorter surgical times compared to endoloops. Recent guidelines also endorse the use of polymeric clips due to their cost effectiveness and efficiency**. Furthermore, study showed fewer overall complications than using endoloops . However, there is a lack of sufficient evidence based data on this topic. This study aims to compare the effectiveness and safety of the widely available polymer locking ligation system that is Hem o Lok® clip versus the endoloop technique for stump closure in laparoscopic appendectomy.**
Hypothesis Hem o Lok® Clips are effective and safer than Endo Loops for Appendicular Stump Closure in Laparoscopic Appendectomy.
Patients will be randomized into one of the two study groups based on there order of arrival in opd all odd number patient will be group A hem o lok clip and all even number patient will be group B endoloop.
Patient will be followed for 40 days .in this duration patient will be assessed on day of discharge ,on the day when patient revisit for suture removal ,and 40 day after surgery .In addition patient will be assessed in between if any complications arise and patient revisit opd .
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.acute appendicitiS 2.chronic appendicitis.
Exclusion Criteria
- •1.perforated appendicitis 2.necrotizing appendicitis 3.pregnant females 4.laparoscopic converted to open appendectomy 5.concomitant another procedure 6.patient not willing to be part of study.
Outcomes
Primary Outcomes
The time required to close the appendicular stump and investigate the differences in post-operative complications, including surgical site infections and stump leaks, as well as the length of hospital stay and recovery times between the two closure techniques.
Time Frame: Operative time and postoperative day 40.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Darshan Jalwal
All India Institute of Medical Sciences,Gorakhpur