NCT06826651

Brief Summary

Acute Appendicitis is the most frequent acute pathological abdominal illness needing immediate surgery. The laparoscopic appendectomy (LA) has become more popular and is advised as the first course of treatment, particularly for female, obese, and elderly patients.LA can also give surgeons a greater field view and identification of other abdominal organs that can have different pathologies that could mimic the symptoms of acute appendicitis.The most crucial step in preventing major complications such postoperative bleeding, peritonitis, sepsis is sealing the mesoappendix. Due to this circumstance, surgeons are looking for alternative treatments for LA. The best technique for sealing mesoappendix should be affordable, practical, safe, and easy to apply technically. Extracorporeal sliding knots, intracorporeal ligations, endo-loops, nonabsorbable polymer clips (Hem-o-lock clips), hand-made loops, and Ligasure usage, and bipolar cautery division are some of the techniques utilized at LA to seal mesoappendix. According to studies, each of these techniques is secure and practicable.5 In this study, there is a comparative study between using Bipolar diathermy as a source of sealing and other mechanical closure techniques for mesoappendix To assess effect of energy source sealing of mesoappendix by using Bipolar diathermy in comparison to mechanical closure by clips as regard outcome and complications.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Mar 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Mar 2025Apr 2028

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • intraoperative blood loss

    amount of blood loss will be calcculated by number of towel used and aomunt of blood in sution

    baseline

Study Arms (2)

Group A

EXPERIMENTAL

Laparoscopic appendectomy, using of bipolar diathermy to coagulate mesoappendix

Procedure: laparoscopic appendectomyProcedure: bipolar diathermy

Group B

EXPERIMENTAL

laparoscopic appendectomy, using surgical clips in closure of mesoappendix

Procedure: laparoscopic appendectomyProcedure: clips closure

Interventions

By using laparoscopy, after achieving conclusive identification of the mesoappendix

Group AGroup B

the mesoappendix coagulated using bipolar diathermy, then cut with scissor.

Group A
clips closurePROCEDURE

mesoappendix will be divided between 3 clips, two placed distally and one proximally. The mesoappendix will be cut in between the clips.

Group B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to AUH with uncomplicated acute appendicitis or chronic appendicitis
  • Age group (18-70)

You may not qualify if:

  • patients with complex appendicitis (appendicular mass, abscess, etc).
  • patients who had the following conditions: cirrhosis with ascites, abdominal distention, and coagulation disorders, cardiac patients; shock upon arrival, a large ventral hernia, and inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

February 14, 2025

Record last verified: 2025-02