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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture ligation | Active Comparator | Participants will undergo laparoscopic appendectomy where the base of the appendix is secured using conventional intracorporeal suture ligation, using absorbable sutures. |
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| Harmonic Scalpel | Experimental | Participants in this group will undergo laparoscopic appendectomy in which the base of the appendix is sealed and divided using a harmonic scalpel. The device simultaneously cuts and coagulates tissue using ultrasonic energy, potentially reducing operative time, blood loss, and thermal injury compared to conventional methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture ligation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | 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. | Intraoperative( measured during surgical procedure on day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Position of appendix | Anatomical position of the appendix (e.g., retrocecal, pelvic, subhepatic) recorded intraoperatively to assess distribution and influence on technical difficulty or operative time. | Intraoperative ( day 1) |
| Postoperative Leak |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Apoorva Mathur, MBBS | Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur | Kanpur | Uttar Pradesh | 208002 | India |
De-identified individual participant data (IPD) related to operative time, hospital stay, and postoperative complications
6 months after publication of results for 2 years
Qualified researchers upon reasonable request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2025 | Jun 18, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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Randomized, Parallel Group, Active controlled trial Computer generated randomisation
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| Harmonic Scalpel | Device | 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. |
|
Presence of intra-abdominal fluid collection or fecal contamination diagnosed clinically or via imaging, indicating leak from the appendix stump.
| Upto 7 days post-operation |
| Postoperative Ileus | Delayed return of bowel function defined by absence of flatus or bowel movements, abdominal distension, or need for nasogastric decompression. | Upto 5 days post-operation |
| Surgical site infection | Superficial or deep wound infection including erythema, discharge, or wound dehiscence. | Up to 30 days post-operation |
| Hospital stay | Total number of days from the date of operation to discharge from the hospital. | From date of surgery until discharge, assessed upto 14 days |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |