UMIN-CTR Clinical Trial

Public title

Multicenter Collaborative Study on the Safety and Efficacy of Laparoscopic Surgery for Acute Appendicitis in Pregnant Women

Acronym

A Multicenter Collaborative Study on Appendicitis in Pregnant Women

Scientific Title

Multicenter Collaborative Study on the Safety and Efficacy of Laparoscopic Surgery for Acute Appendicitis in Pregnant Women

Scientific Title:Acronym

A Multicenter Collaborative Study on Appendicitis in Pregnant Women

Region

Japan

Condition

Acute appendicitis

Classification by specialty

Surgery in general	Gastrointestinal surgery	Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Acute appendicitis in pregnant women can deteriorate rapidly, necessitating accurate diagnosis and prompt appropriate treatment. If surgical intervention is deemed necessary, consideration must be given not only to the mother but also to the potential impact on the fetus. A large-scale meta-analysis conducted overseas reported a higher fetal mortality rate for laparoscopic surgery compared to open surgery (3.8% vs. 3.1%, P < 0.0001). The guidelines of the Japan Society for Endoscopic Surgery state that "Laparoscopic surgery for appendicitis in pregnant women showed significantly higher rates of miscarriage and fetal mortality compared to open surgery. The rates of preterm delivery and other perioperative and obstetric complications were similar. The indications for laparoscopic surgery in pregnant women should be approached cautiously, and further verification through clinical trials is necessary." Recent advancements in laparoscopic surgical techniques and device development have significantly changed the landscape compared to previous reports. Therefore, it is crucial to evaluate the safety and efficacy of laparoscopic appendectomy in pregnant women, including its impact on the fetus, through real-world clinical investigations.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Miscarriage and stillbirth rates

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

atients who develop acute appendicitis during pregnancy and undergo either open or laparoscopic surgery

Key exclusion criteria

1) Patients who develop acute appendicitis during pregnancy but undergo appendectomy after delivery.
2) Patients with a history of diseases other than acute appendicitis that present with peritonitis during pregnancy.
3) Patients who have undergone surgeries other than appendectomy during pregnancy.
4) Patients undergoing treatment for malignant tumors or with a history of malignancies.
5) Patients deemed unsuitable for participation in the clinical trial by the investigator in charge.

Target sample size

200

Name of lead principal investigator

1st name	Tomonori
Middle name
Last name	Akagi

Organization

Oita University Faculty of Medicine

Division name

Department of Gastroenterological and Pediatric Surgery

Zip code

879-5593

Address

1-1 Hasama, Yufu-city, Oita

TEL

097-586-5843

Email

tomakagi@oita-u.ac.jp

Name of contact person

1st name	Kaatsuhiro
Middle name
Last name	Ogawa

Organization

Oita University Faculty of Medicine

Division name

Department of Gastroenterological and Pediatric Surgery

Zip code

879-5593

Address

1-1 Hasama, Yufu-city, Oita

TEL

097-586-5843

Homepage URL

Email

katsu-ogawa@oita-u.ac.jp

Institute

Japan Society of Laparoscopic Colorectal Surgery

Institute

Department

Personal name

Organization

Japan Society of Laparoscopic Colorectal Surgery

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Oita University Faculty of Medicine

Address

1-1 Hasama, Yufu-city, Oita

Tel

097-586-6380

Email

rinrikenkyu@oita-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

07

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

07

Month

08

Day

Date of IRB

Anticipated trial start date

2023

Year

07

Month

14

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Research Objectives:
Patient Background: Age at the time of surgery, gestational age at the time of surgery, gender, height, weight, BMI, ASA classification, complications during pregnancy, history of abdominal surgery, presence of diabetes, cardiovascular disease, respiratory disease, and other comorbidities.
Perioperative Outcomes: Diagnostic methods (ultrasound, CT scan, MRI), urgency of surgery, state of peritonitis (localized or diffuse), state of appendicitis (simple, complicated, presence of abscess formation), preoperative preparations, surgical technique (open or laparoscopic), incision site (midline incision, transverse incision, Pfannenstiel incision, or others), number and placement of trocars (for laparoscopic surgery), pneumoperitoneum pressure (for laparoscopic surgery), appendix handling method (ligation and excision, burying, mechanical anastomosis, Endo-loop, or others), intra-abdominal irrigation, and drainage placement.
Surgical Outcomes: Surgery date, operation time, blood loss, intraoperative complications (requiring intraoperative intervention), conversion to open surgery due to complications, postoperative complications (graded according to the Clavien-Dindo classification, including complications occurring until the initial discharge date), specific complications (anastomotic bleeding, intra-abdominal bleeding, intra-abdominal infection, wound infection, paralytic ileus, obstructive ileus, wound dehiscence, and others), need for reoperation, and length of hospital stay.
Pathological Findings: Catarrhal, phlegmonous, gangrenous appendicitis, presence of fecalith.
Pregnancy Outcomes: Miscarriage, stillbirth, gestational age at delivery (preterm, term, post-term), birth weight, Apgar score.

Registered date

2023

Year

07

Month

05

Day

Last modified on

2023

Year

07

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058786