EmergenciesNCT06818942
Nomogram for Predicting Difficult Laparoscopic Appendectomy
An observational study of Emergencies, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
No prior studies have stratified the difficulty of laparoscopic appendectomy (LA). The investigators aimed to investigate preoperative factors as indicators of difficult LAs based on the experience of surgical trainees and to develop a predictive model accordingly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergencies
- What is being tested?
- Observations on preoperative and intraoperative factors influencing the difficulty of surgery
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2025to 31 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed acute appendicitis, were willing to and suitable to undergo laparoscopic appendectomy (LA). Patients were well informed about the surgical procedure and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.
Who may be able to join
- Clinical diagnosis of acute appendicitis
- Participants who underwent laparoscopic appendectomy
Who cannot join
- Participants refused or could not tolerate laparoscopic appendectomy
- Incomplete preoperative examination or missed information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Ling Zhan, Doctor, 08615821120972, rebecca0428zhan@163.com
About this study
No prior studies have stratified the difficulty of laparoscopic appendectomy (LA). The investigators aimed to investigate preoperative factors as indicators of difficult LAs based on the experience of surgical trainees and to develop a predictive model accordingly.
Read the detailed description
Acute appendicitis is the most common cause of surgical emergencies and laparoscopic appendectomy (LA) is usually attempted by surgical trainees. This study aim to explore the preoperative and intraoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in training programs.
- Conditions
- Emergencies
- Being tested
- Observations on preoperative and intraoperative factors influencing the difficulty of surgery
- Keywords
- Laparoscopic appendectomy, Surgical difficulty, Training program
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observations on preoperative and intraoperative factors influencing the difficulty of surgeryOther
Age, body mass index, gender, inflammatory indicators, previous history of abdominal surgery, underlying disease
| Study group | Role | What they receive |
|---|---|---|
| Difficult laparoscopic appendectomy | (1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or uncontrolled bleeding (3) conversion to open approach Receives: Other: Observations on preoperative and intraoperative factors influencing the difficulty of surgery | |
| Non-difficult laparoscopic appendectomy | the remaining of the entire study cases excluding the difficult cases Receives: Other: Observations on preoperative and intraoperative factors influencing the difficulty of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
Measured: During surgery
Number of participants with postoperative complications
Postoperative bleeding, surgical site infection and other complications
Measured: through study completion, an average of 1 year
Hospitalization
days of hospitalization
Measured: 1 day of discharge
Degree of pain
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain
Measured: approximately 4 hours after surgery and on postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start26 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Zhan, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818942
- Sponsor's protocol ID
- 2025-KY-094(K)
- Status last verified
- May 2026
- First submitted
- 26 Jan 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data are available on request due to privacy or other restrictions. The data that support the findings of this study are available on request from Ling Zhan. The data are not publicly available due to them containing information that could compromise research participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nomogram for Predicting Difficult Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT06818942
- Acronym / sponsor ID
- 2025-KY-094(K)
- Conditions
- Emergencies
- Keywords
- Laparoscopic appendectomy, Surgical difficulty, Training program
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 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.
No prior studies have stratified the difficulty of laparoscopic appendectomy (LA). The investigators aimed to investigate preoperative factors as indicators of difficult LAs based on the experience of surgical trainees and to develop a predictive model accordingly.
Detailed description
Acute appendicitis is the most common cause of surgical emergencies and laparoscopic appendectomy (LA) is usually attempted by surgical trainees. This study aim to explore the preoperative and intraoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in training programs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult laparoscopic appendectomy | – | Other: Observations on preoperative and intraoperative factors influencing the difficulty of surgery(1) operative time more than 75% of the overall study cases (2) severe intraoperative vascular or uncontrolled bleeding (3) conversion to open approach |
| Non-difficult laparoscopic appendectomy | – | Other: Observations on preoperative and intraoperative factors influencing the difficulty of surgerythe remaining of the entire study cases excluding the difficult cases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed acute appendicitis, were willing to and suitable to undergo laparoscopic appendectomy (LA). Patients were well informed about the surgical procedure and were aware of the potential benefits and risks. Patient consented for us to use perioperative data.
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute appendicitis
- Participants who underwent laparoscopic appendectomy
Key exclusion criteria (2 listed)
- Participants refused or could not tolerate laparoscopic appendectomy
- Incomplete preoperative examination or missed information
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 |
|---|---|---|
| Observations on preoperative and intraoperative factors influencing the difficulty of surgeryAge, body mass index, gender, inflammatory indicators, previous history of abdominal surgery, underlying disease | Other | Difficult laparoscopic appendectomy, Non-difficult laparoscopic appendectomy |
Primary outcome
Operative time
Time frame: During surgery
operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
Number of participants with postoperative complications
Time frame: through study completion, an average of 1 year
Postoperative bleeding, surgical site infection and other complications
Hospitalization
Time frame: 1 day of discharge
days of hospitalization
Degree of pain
Time frame: approximately 4 hours after surgery and on postoperative day 1
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain
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 7 May 2026.
- Individual participant dataSharing planned: Undecided. Data are available on request due to privacy or other restrictions. The data that support the findings of this study are available on request from Ling Zhan. The data are not publicly available due to them containing information that could compromise research participant privacy.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Shanghai 6th People's Hospital at 1 site in China.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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 China. 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?
Contact Ling Zhan, Dr (08615821120972, rebecca0428zhan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: During surgery). The study lists 4 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 7 May 2026.