UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054467 |
|---|---|
| Receipt number | R000062212 |
| Scientific Title | Drainage of Laparoscopic Appendectomy for Perforated Appendicitis (DLAP) study |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2025/11/23 20:01:27 |
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Basic information
Public title
Drainage of Laparoscopic Appendectomy for Perforated Appendicitis study
Acronym
DLAP study
Scientific Title
Drainage of Laparoscopic Appendectomy for Perforated Appendicitis (DLAP) study
Scientific Title:Acronym
DLAP study
Region
| Japan |
Condition
Condition
Perforated Appendicitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the incidence of postoperative residual abscess is reduced in the drainage group when laparoscopic appendicectomy is performed for perforated appendicitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of postoperative residual abscess
Key secondary outcomes
Length of post-operative hospital stay, duration of antimicrobials and total hospitalisation costs
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent laparoscopic appendicectomy for perforated appendicitis between 1 January 2015 and 31 December 2023.
Definition of 'perforated appendicitis': 'appendicitis' diagnosed as 'perforated' on preoperative CT or intraoperative findings. Abscess formation may or may not be present. It does not include those diagnosed as 'perforated' on pathology. Perforation" is only a clinical finding.
Definition of 'laparoscopic appendicectomy': the number of ports is not specified. However, as a fully specoscopic procedure, open transition cases and hybrid cases (those treated by giving and removing from the umbilicus) are excluded. Partial cecal resections are included, but partial colon resections such as ileal resection or right semi-colon resection are excluded.
Key exclusion criteria
1: Under 16 years of age
2: Pregnant women
3: Open transition cases, hybrid cases
4: Partial colon resection other than partial cecal resection
5: Those who refused to participate in the study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Akutsu |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Trauma and Acute Care Surgery, division of acute critical care medicine
Zip code
300-0028
Address
4-1-1 Otsuno, Tsuchiura, Ibaraki Japan
TEL
0298303711
doitin41@gmail.com
Public contact
Name of contact person
| 1st name | tomohiro |
| Middle name | |
| Last name | Akutsu |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Trauma and Acute Care Surgery, division of acute critical care medicine
Zip code
300-0028
Address
4-1-1 Otsuno, Tsuchiura, Ibaraki Japan
TEL
0298303711
Homepage URL
doitin41@gmail.com
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Tomohiro Akutsu
Funding Source
Organization
Japanese society of abdominal emergency medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tschiura kyodo general hospital Committee on Clinical Research Ethics
Address
4-1-1 Otsuno, Tsuchiura, Ibaraki Japan
Tel
0298303711
doitin41@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 30 | Day |
Other
Other related information
The following information will be collected from the medical records of patients who have undergone laparoscopic appendicectomy for perforated appendicitis in the last nine years at the participating centres of the study _
z Basic patient information: age, sex, height, weight, date of symptom onset, name of comorbidity on admission, life history, date of admission.
z Surgical-related information: date of surgery, vital signs on admission to surgery, presence/absence of catecholamine, presence/absence of sepsis, site of tenderness, presence/absence of peritoneal irritation symptoms, site, ASA-PS, number of ports, site of contamination, method of dissection, presence/absence of drain placement, drain placement position, amount of flushing, amount of bleeding, duration of surgery.
z Non-operative treatment-related information: duration of antimicrobial use, post-operative complications, presence/absence of residual abscess, details of residual abscess, total hospitalisation costs
00 Pre-operative laboratory data: WBC, Hb, CRP, Alb, Cre, procalcitonin, CT findings
0 Outcome: days in ICU, days in hospital, days in hospital after surgery, outcome at discharge, whether readmission.
The main analysis will be a mixed-effects model taking into account facility factors. The incidence of abscesses in patients undergoing laparoscopic appendicectomy for perforated appendicitis was 8.1% in our data. Therefore, assuming an incidence of abscesses of around 5-10%, we plan to collect around 1000 cases for the construction of a multivariate model adjusted for key confounding factors. If the number of cases collected is less than the above, we plan to use other methods such as propensity score matching for sufficient background factor adjustment.
Management information
Registered date
| 2024 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062212
