AppendicitisHASSELNCT07049965
Comparative Study of Harmonic Scalpel vs. Suture Ligation for Appendix Base During Laparoscopic Appendectomy
A study testing Suture ligation and Harmonic Scalpel in people with Appendicitis, run by GSVM Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Suture ligation and Harmonic Scalpel
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 5 - 65 years
- Any gender
- Patient willing to undergo laparoscopic appendectomy
- Acute appendicitis confirmed by clinical and radiological analysis
- Alvarado Score ≥7
- Alvarado Score ≥5 with positive ultrasound findings
Who cannot join
- Patient with base of appendix highly inflamed / gangrenous
- 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.
- Patients declared unfit for laparoscopic surgery during preoperative assessment
- Patients having severe co morbid condition - COPD/CAD/CHF
Trial locations and contacts
1 site in 1 country.
India1 site
Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur
Kanpur, Uttar Pradesh, 208002
About this study
Official title: Clinical Profile of Appendicitis and Comparative Study for Use of Harmonic Scalpel (Seal and Cut) and Suture Ligation of Base of Appendix During Laparoscopic Appendectomy
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.
Read the 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.
- Conditions
- Appendicitis
- Being tested
- Suture ligation, Harmonic Scalpel
- Keywords
- Laparoscopic appendicectomy, Harmonic scalpel, Suture ligation, Surgical site infection, Operative time, Appendicitis, Appendiceal stump closure
- Medical subject headings
- Appendicitis, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture ligationProcedure or surgery
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.
Harmonic ScalpelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Suture ligation |
| 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. Receives: Device: Harmonic Scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative( measured during surgical procedure on day 1)
Secondary outcomes (5)
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.
Measured: Intraoperative ( day 1)
Postoperative Leak
Presence of intra-abdominal fluid collection or fecal contamination diagnosed clinically or via imaging, indicating leak from the appendix stump.
Measured: 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.
Measured: Upto 5 days post-operation
Surgical site infection
Superficial or deep wound infection including erythema, discharge, or wound dehiscence.
Measured: Up to 30 days post-operation
Hospital stay
Total number of days from the date of operation to discharge from the hospital.
Measured: From date of surgery until discharge, assessed upto 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel Group, Active controlled trial Computer generated randomisation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GSVM Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apoorva Mathur, GSVM Medical College
- Investigators
- Dr. Apoorva Mathur, MBBS, Principal investigator, Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049965
- Sponsor's protocol ID
- EC/BMHR/2024/35
- Acronym
- HASSEL
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to operative time, hospital stay, and postoperative complications
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile of Appendicitis and Comparative Study for Use of Harmonic Scalpel (Seal and Cut) and Suture Ligation of Base of Appendix During Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT07049965
- Acronym / sponsor ID
- HASSEL / EC/BMHR/2024/35
- Conditions
- Appendicitis
- Keywords
- Laparoscopic appendicectomy, Harmonic scalpel, Suture ligation, Surgical site infection, Operative time, Appendicitis, Appendiceal stump closure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GSVM Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, Parallel Group, Active controlled trial Computer generated randomisation
| Arm | Type | Receives |
|---|---|---|
| Suture ligation | Active comparator | Procedure: Suture ligationParticipants will undergo laparoscopic appendectomy where the base of the appendix is secured using conventional intracorporeal suture ligation, using absorbable sutures. |
| Harmonic Scalpel | Experimental | Device: Harmonic ScalpelParticipants 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. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 5 - 65 years
- Any gender
- Patient willing to undergo laparoscopic appendectomy
- Acute appendicitis confirmed by clinical and radiological analysis
- Alvarado Score ≥7
Key exclusion criteria (4 listed)
- Patient with base of appendix highly inflamed / gangrenous
- 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.
- Patients declared unfit for laparoscopic surgery during preoperative assessment
- Patients having severe co morbid condition - COPD/CAD/CHF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture ligationParticipants 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. | Procedure or surgery | Suture ligation |
| Harmonic ScalpelParticipants 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. | Device | Harmonic Scalpel |
Primary outcome
Operative time
Time frame: 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.
5 secondary outcomes
Position of appendix
Time frame: Intraoperative ( day 1)
Postoperative Leak
Time frame: Upto 7 days post-operation
Postoperative Ileus
Time frame: Upto 5 days post-operation
Surgical site infection
Time frame: Up to 30 days post-operation
Hospital stay
Time frame: From date of surgery until discharge, assessed upto 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to operative time, hospital stay, and postoperative complications
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Apoorva Mathur, MBBS principal investigator
Ganesh Shankar Vidhyarthi Memorial Medical College Kanpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture ligation and Harmonic Scalpel in people with Appendicitis, run by GSVM Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative( measured during surgical procedure on day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.