An Early Phase 1 interventional study of Hand-made Extracorporeal Knotting and Clip Closure in Appendicectomy, sponsored by Punjab Health Care Commission. Completed at 1 site in Pakistan. Open to participants aged 10 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Punjab Health Care Commission · Early Phase 1, Interventional, and Treatment
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.
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 190 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Punjab Health Care Commission is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Hand-made Extracorporeal Knotting
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
Procedure: Clip Closure
Appendiceal stump closure performed using a hand-made extracorporeal knot (modified Tayside knot technique). Two knots will be applied. Used during laparoscopic appendectomy
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
Post operative ileus
Postoperative ileus defined as absence of bowel movement, passage of flatus, or audible bowel sounds up to 48 hours after surgery
Time frame: 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.
Time frame: within 15 days of surgery
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Punjab Health Care Commission