Appendicitis
Conditions
Keywords
Laparoscopic appendicectomy, Harmonic scalpel, Suture ligation, Surgical site infection, Operative time, Appendicitis, Appendiceal stump closure
Brief summary
This study is a comparative study between use of suture ligation vs harmonic scalpel for sealing and cutting the base of appendix. The ideal method for closing the appendix stump should be safe, reliable, simple to use, and cost-effective. Various techniques have been introduced for this purpose, each with its advantages and disadvantages. However, no clear consensus has been reached in the literature regarding which technique is superior. This study is to compare the two groups in terms of operative time and postoperative complications and to reach a conclusion as to which one of the two is superior.
Detailed description
Acute appendicitis is one of the most common causes of emergency abdominal surgery worldwide. Laparoscopic appendectomy has become the standard of care due to its advantages of faster recovery and reduced postoperative complications. A key step in the procedure is the secure closure of the base of the appendix to prevent intra-abdominal leakage and stump complications. Traditionally, this is done using intracorporeal suture ligation or endoloops. However, the introduction of energy devices such as the harmonic scalpel has offered a potential alternative that combines cutting and coagulation, potentially reducing operative time and simplifying the procedure. This prospective interventional study aims to compare the effectiveness and safety of harmonic scalpel (seal-and-cut technique) versus conventional suture ligation for closure of the appendix base during laparoscopic appendectomy in patients with uncomplicated acute appendicitis. A total of 60 patients will be enrolled and randomized into two groups: Group A (Harmonic Scalpel) and Group B (Suture Ligation). Both groups will undergo standard laparoscopic appendectomy with the only variable being the method of securing the appendix stump. The primary outcomes of interest include operative time,Postoperative leak, Postoperative ileus,Surgical site infection and Hospital Stay and secondary outcome of interest include Recovery and Postoperative complications. Follow-up will be done on postoperative day 1, day 7, day 30 and 3 months. This study seeks to determine whether the harmonic scalpel offers a safe and effective alternative to conventional ligation, potentially simplifying surgical technique and improving patient outcomes.
Interventions
PROCEDURESuture ligation
Participants will undergo laparoscopic appendectomy in which the base of the appendix is ligated using intracorporeal suturing with absorbable material. This is the conventional technique used to prevent stump leakage.
DEVICEHarmonic Scalpel
Participants will undergo laparoscopic appendectomy where the base of the appendix is sealed and divided using the harmonic scalpel. This ultrasonic energy-based device cuts and coagulates tissue simultaneously, potentially reducing operative time and blood loss.
Sponsors
GSVM Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized, Parallel Group, Active controlled trial Computer generated randomisation
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 5 - 65 years 2. Any gender 3. Patient willing to undergo laparoscopic appendectomy 4. Acute appendicitis confirmed by clinical and radiological analysis 5. Alvarado Score ≥7 6. Alvarado Score ≥5 with positive ultrasound findings
Exclusion criteria
1. Patient with base of appendix highly inflamed / gangrenous 2. Any other intra-abdominal pathology other than acute appendicitis, e.g., appendicular mass, appendicular abscess, tuberculosis, carcinoid tumor, pelvic inflammatory disease, ovarian tumors, ceacal mass, etc. 3. Patients declared unfit for laparoscopic surgery during preoperative assessment 4. Patients having severe co morbid condition - COPD/CAD/CHF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative( measured during surgical procedure on day 1) | Total duration of surgery in minutes, measured from skin incision to completion of appendix base closure. Used to compare efficiency between harmonic scalpel and suture ligation techniques. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Position of appendix | Intraoperative ( day 1) | Anatomical position of the appendix (e.g., retrocecal, pelvic, subhepatic) recorded intraoperatively to assess distribution and influence on technical difficulty or operative time. |
| Postoperative Leak | Upto 7 days post-operation | Presence of intra-abdominal fluid collection or fecal contamination diagnosed clinically or via imaging, indicating leak from the appendix stump. |
| Postoperative Ileus | Upto 5 days post-operation | Delayed return of bowel function defined by absence of flatus or bowel movements, abdominal distension, or need for nasogastric decompression. |
| Surgical site infection | Up to 30 days post-operation | Superficial or deep wound infection including erythema, discharge, or wound dehiscence. |
| Hospital stay | From date of surgery until discharge, assessed upto 14 days | Total number of days from the date of operation to discharge from the hospital. |
Countries
India
Outcome results
None listed