Nomogram for Predicting Difficult Laparoscopic Appendectomy

May 2, 2026 updated by: Ling Zhan, Shanghai 6th People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Clinical diagnosis of acute appendicitis
  • Participants who underwent laparoscopic appendectomy

Exclusion Criteria:

  • Participants refused or could not tolerate laparoscopic appendectomy
  • Incomplete preoperative examination or missed information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Observations on preoperative and intraoperative factors influencing the difficulty of surgery
Age, body mass index, gender, inflammatory indicators, previous history of abdominal surgery, underlying disease
Non-difficult laparoscopic appendectomy
the remaining of the entire study cases excluding the difficult cases
Other: Observations on preoperative and intraoperative factors influencing the difficulty of surgery
Age, body mass index, gender, inflammatory indicators, previous history of abdominal surgery, underlying disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: During surgery
operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet
During surgery
Number of participants with postoperative complications
Time Frame: through study completion, an average of 1 year
Postoperative bleeding, surgical site infection and other complications
through study completion, an average of 1 year
Hospitalization
Time Frame: 1 day of discharge
days of hospitalization
1 day of discharge
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
approximately 4 hours after surgery and on postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

February 8, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KY-094(K)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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