AppendicectomyEarly Phase 1NCT07281612
Hand-made Extracorporeal Knotting Versus Clip for Stump Closure in Laparoscopic Appendectomy
A Early Phase 1 study testing Hand-made Extracorporeal Knotting and Clip Closure in people with Appendicectomy, run by Punjab Health Care Commission at 1 site in Pakistan.
Trial summary
Acute appendicitis is one of the most common causes of emergency abdominal surgery. Laparoscopic appendectomy is now widely used because it offers advantages such as shorter hospital stay, less postoperative pain, and better cosmetic outcomes. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Appendicectomy
- What is being tested?
- Hand-made Extracorporeal Knotting and Clip Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 30 Nov 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 10 to 70 years
- Either sex
- Clinical diagnosis of acute appendicitis with Alvarado score >6
- ASA physical status I-III
- Planned laparoscopic appendectomy
Who cannot join
- Patient request for open appendectomy
- Complicated appendicitis (perforation, appendicular abscess, or appendicular mass)
- Local or diffuse peritonitis
- Friable or necrotic appendix base
- Pelvic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Hand-made Extracorporeal Knotting Versus Clip for Stump Closure in Laparoscopic Appendectomy
Acute appendicitis is one of the most common causes of emergency abdominal surgery. Laparoscopic appendectomy is now widely used because it offers advantages such as shorter hospital stay, less postoperative pain, and better cosmetic outcomes. However, the optimal technique for appendiceal stump closure remains unclear, and different methods such as endoloops, clips, sutures, and staplers are currently used in clinical practice.
This randomized controlled trial will compare two commonly used stump closure techniques during laparoscopic appendectomy: hand-made extracorporeal knotting and polymeric clip application. Participants will be randomly assigned in a 1:1 ratio to either group. The study outcomes include failure of technique, postoperative ileus, and intra-abdominal infection within 15 days after surgery.
The aim of this study is to determine whether hand-made extracorporeal knotting is more effective than clip application in reducing postoperative complications related to appendiceal stump closure.
Read the detailed description
Acute appendicitis is a major cause of acute abdomen and a frequent indication for emergency surgery. Laparoscopic appendectomy has become the preferred surgical approach due to advantages such as reduced postoperative pain, quicker recovery, lower wound infection rates, and improved cosmetic outcomes. Despite technical advancements, appendiceal stump leakage remains a serious postoperative concern, potentially resulting in intra-abdominal sepsis and reoperation.
A variety of appendiceal stump closure techniques are in use, including endoloops, sutures, staplers, and clips. Both hand-made extracorporeal knotting and polymeric nonabsorbable clips (Hem-o-lok®) are commonly employed and considered safe. Hand-made extracorporeal knotting has potential advantages of lower cost and usability in resource-limited settings, but the optimal closure technique remains controversial and evidence is limited.
This study is designed as a single-center, prospective, parallel-group randomized controlled trial conducted at Abbas Institute of Medical Sciences, Muzaffarabad. A total of 190 patients aged 10-70 years presenting with acute appendicitis and undergoing laparoscopic appendectomy will be enrolled. After diagnostic laparoscopy and confirmation of eligibility, participants will be randomized by simple lottery method into one of two groups:
Intervention Group: appendiceal stump closure using hand-made extracorporeal knotting (modified Tayside knot), with two knots applied.
Comparator Group: appendiceal stump closure using a nonabsorbable polymeric Hem-o-lok® clip.
Demographic variables, comorbidities, stump diameter, and operative time will be recorded. Outcomes will be assessed intraoperatively and postoperatively, with follow-up continuing until postoperative day 15. The primary outcome is intra-abdominal infection within 15 days. Secondary outcomes include failure of technique during surgery and postoperative ileus.
Statistical analysis will be performed using SPSS software. Categorical variables will be analyzed using a chi-square test, and continuous variables will be summarized as mean ± standard deviation. A p-value ≤ 0.05 will be considered statistically significant.
The findings of this trial may help determine whether hand-made extracorporeal knotting provides superior clinical outcomes or cost advantages compared to polymeric clips, and may guide standardization of appendiceal stump closure techniques in laparoscopic appendectomy, particularly in low-resource surgical settings.
- Conditions
- Appendicectomy
- Being tested
- Hand-made Extracorporeal Knotting, Clip Closure
- Keywords
- Appendicectomy, stump closure, knotting, clip, surgery, ileus
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-made Extracorporeal KnottingProcedure or surgery
Appendiceal stump closure performed using a hand-made extracorporeal knot (modified Tayside knot technique). Two knots will be applied. Used during laparoscopic appendectomy
Clip ClosureProcedure or surgery
Appendiceal stump closure performed using a nonabsorbable polymeric Hem-o-lok® clip system (Teleflex Medical, USA). The clip is applied to the stump during laparoscopic appendectomy
| Study group | Role | What they receive |
|---|---|---|
| Hand Made Knot Group | Experimental | Appendiceal stump closure using hand-made extracorporeal knotting (modified Tayside knot). Two extracorporeal knots will be applied to secure the appendiceal stump during laparoscopic appendectomy. Receives: Procedure: Hand-made Extracorporeal Knotting |
| Arm 2 | Active comparator | Appendiceal stump closure using a nonabsorbable polymeric Hem-o-lok® clip. One clip is applied at the appendiceal stump and a second clip may be added 2-3 mm above the first if needed Receives: Procedure: Clip Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative ileus
Postoperative ileus defined as absence of bowel movement, passage of flatus, or audible bowel sounds up to 48 hours after surgery
Measured: within 48 hours of surgery
Intra abdominal infection
Intra-abdominal infection defined as presence of fever, abdominal pain, or systemic symptoms confirmed by CT scan showing intra-abdominal abscess or infection requiring medical or surgical treatment.
Measured: within 15 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Mar 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicectomyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Punjab Health Care Commission
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haseeb Ul Hassan, Abbas Institute of Medical Sciences
- Investigators
- Haseeb Ul Hassan, MBBS, Principal investigator, AIMS Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281612
- Sponsor's protocol ID
- AIMS-APP-Knot-vs-Clip
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, plans for sharing individual participant data (IPD) have not been finalized. Data access may be limited due to patient privacy considerations, lack of a secure data-sharing framework, and institutional policies regarding confidentiality. If future sharing becomes possible, a detailed plan will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Hand-made Extracorporeal Knotting Versus Clip for Stump Closure in Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT07281612
- Acronym / sponsor ID
- AIMS-APP-Knot-vs-Clip
- Conditions
- Appendicectomy
- Keywords
- Appendicectomy, stump closure, knotting, clip, surgery, ileus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Punjab Health Care CommissionUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 15 Dec 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.
Acute appendicitis is one of the most common causes of emergency abdominal surgery. Laparoscopic appendectomy is now widely used because it offers advantages such as shorter hospital stay, less postoperative pain, and better cosmetic outcomes. However, the optimal technique for appendiceal stump closure remains unclear, and different methods such as endoloops, clips, sutures, and staplers are currently used in clinical practice.
This randomized controlled trial will compare two commonly used stump closure techniques during laparoscopic appendectomy: hand-made extracorporeal knotting and polymeric clip application. Participants will be randomly assigned in a 1:1 ratio to either group. The study outcomes include failure of technique, postoperative ileus, and intra-abdominal infection within 15 days after surgery.
The aim of this study is to determine whether hand-made extracorporeal knotting is more effective than clip application in reducing postoperative complications related to appendiceal stump closure.
Detailed description
Acute appendicitis is a major cause of acute abdomen and a frequent indication for emergency surgery. Laparoscopic appendectomy has become the preferred surgical approach due to advantages such as reduced postoperative pain, quicker recovery, lower wound infection rates, and improved cosmetic outcomes. Despite technical advancements, appendiceal stump leakage remains a serious postoperative concern, potentially resulting in intra-abdominal sepsis and reoperation.
A variety of appendiceal stump closure techniques are in use, including endoloops, sutures, staplers, and clips. Both hand-made extracorporeal knotting and polymeric nonabsorbable clips (Hem-o-lok®) are commonly employed and considered safe. Hand-made extracorporeal knotting has potential advantages of lower cost and usability in resource-limited settings, but the optimal closure technique remains controversial and evidence is limited.
This study is designed as a single-center, prospective, parallel-group randomized controlled trial conducted at Abbas Institute of Medical Sciences, Muzaffarabad. A total of 190 patients aged 10-70 years presenting with acute appendicitis and undergoing laparoscopic appendectomy will be enrolled. After diagnostic laparoscopy and confirmation of eligibility, participants will be randomized by simple lottery method into one of two groups:
Intervention Group: appendiceal stump closure using hand-made extracorporeal knotting (modified Tayside knot), with two knots applied.
Comparator Group: appendiceal stump closure using a nonabsorbable polymeric Hem-o-lok® clip.
Demographic variables, comorbidities, stump diameter, and operative time will be recorded. Outcomes will be assessed intraoperatively and postoperatively, with follow-up continuing until postoperative day 15. The primary outcome is intra-abdominal infection within 15 days. Secondary outcomes include failure of technique during surgery and postoperative ileus.
Statistical analysis will be performed using SPSS software. Categorical variables will be analyzed using a chi-square test, and continuous variables will be summarized as mean ± standard deviation. A p-value ≤ 0.05 will be considered statistically significant.
The findings of this trial may help determine whether hand-made extracorporeal knotting provides superior clinical outcomes or cost advantages compared to polymeric clips, and may guide standardization of appendiceal stump closure techniques in laparoscopic appendectomy, particularly in low-resource surgical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Made Knot Group | Experimental | Procedure: Hand-made Extracorporeal KnottingAppendiceal stump closure using hand-made extracorporeal knotting (modified Tayside knot). Two extracorporeal knots will be applied to secure the appendiceal stump during laparoscopic appendectomy. |
| Arm 2 | Active comparator | Procedure: Clip ClosureAppendiceal stump closure using a nonabsorbable polymeric Hem-o-lok® clip. One clip is applied at the appendiceal stump and a second clip may be added 2-3 mm above the first if needed |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 10 to 70 years
- Either sex
- Clinical diagnosis of acute appendicitis with Alvarado score >6
- ASA physical status I-III
- Planned laparoscopic appendectomy
Key exclusion criteria (5 listed)
- Patient request for open appendectomy
- Complicated appendicitis (perforation, appendicular abscess, or appendicular mass)
- Local or diffuse peritonitis
- Friable or necrotic appendix base
- Pelvic inflammatory disease
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 |
|---|---|---|
| Hand-made Extracorporeal KnottingAppendiceal stump closure performed using a hand-made extracorporeal knot (modified Tayside knot technique). Two knots will be applied. Used during laparoscopic appendectomy | Procedure or surgery | Hand Made Knot Group |
| Clip ClosureAppendiceal stump closure performed using a nonabsorbable polymeric Hem-o-lok® clip system (Teleflex Medical, USA). The clip is applied to the stump during laparoscopic appendectomy | Procedure or surgery | Arm 2 |
Primary outcome
Post operative ileus
Time frame: within 48 hours of surgery
Postoperative ileus defined as absence of bowel movement, passage of flatus, or audible bowel sounds up to 48 hours after surgery
Intra abdominal infection
Time frame: within 15 days of surgery
Intra-abdominal infection defined as presence of fever, abdominal pain, or systemic symptoms confirmed by CT scan showing intra-abdominal abscess or infection requiring medical or surgical treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided. At this time, plans for sharing individual participant data (IPD) have not been finalized. Data access may be limited due to patient privacy considerations, lack of a secure data-sharing framework, and institutional policies regarding confidentiality. If future sharing becomes possible, a detailed plan will be provided.
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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.
Haseeb Ul Hassan, MBBS principal investigator
AIMS Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hand-made Extracorporeal Knotting and Clip Closure in people with Appendicectomy, run by Punjab Health Care Commission at 1 site in Pakistan.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 15 Dec 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 Pakistan. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post operative ileus (time frame: within 48 hours of surgery). The study lists 2 primary outcomes in all. 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 15 Dec 2025.