Nomogram for Predicting Difficult Laparoscopic Appendectomy

NCT06818942 | Recruiting

• 1 other identifier: 2025-KY-094(K)
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergencies

Keywords

Laparoscopic appendectomy; Surgical difficulty; Training program

Outcome Measures

Primary Outcomes (4)

• Operative time

  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

  Postoperative bleeding, surgical site infection and other complications

  through study completion, an average of 1 year

• Hospitalization

  days of hospitalization

  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

  approximately 4 hours after surgery and on postoperative day 1

Study Arms (2)

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

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

Interventions

Observations on preoperative and intraoperative factors influencing the difficulty of surgery OTHER

Age, body mass index, gender, inflammatory indicators, previous history of abdominal surgery, underlying disease

Difficult laparoscopic appendectomy; Non-difficult laparoscopic appendectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ling Zhan, Dr

CONTACT

08615821120972; rebecca0428zhan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 11, 2025
• Study Start: January 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (1)