Laparoscopic Value in the Management of Acute Abdomen During Pregnancy

NCT ID: NCT05407922

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The term "acute abdomen" is often used to describe the manifestations of any serious intraperitoneal disease, which may indicates surgical intervention. Acute abdomen in pregnancy accounts for approximately 7-10% of all abdominal emergencies.

Several pathologies could contribute acute abdominal pain during pregnancy. They include obstetric and non-obstetric causes. As for the non-obstetric causes , any gastrointestinal or urological disorders could be presented by an acute abdominal pain.

In pregnancy, several factors overlap and making the diagnosis challenging. These factors include the distorted anatomy by the growing uterus that displaces intraperitoneal structures. Additionally, nausea, vomiting, and abdominal pain are considered the normal course during pregnancy especially at the first trimester. Moreover, sure diagnosis must be achieved to operate in a pregnant woman with more possible morbidity and mortality for the mother and\\or fetus.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Laparoscopy can be safely performed during any trimester of pregnancy. Historical recommendations were to limit surgery to the second trimester only, but these recommendations were based on experience with open surgical procedures during pregnancy. These recommendations were thought to minimize the spontaneous abortion rate of surgical intervention during the first trimester, which was reported to be as high as 12%, and to avoid preterm labor, reported in up to 40%, when surgery occurred during the third trimester. However, studies limited to laparoscopy have shown improved outcomes and demonstrated that pregnant patients may undergo laparoscopic surgery safely during any trimester without any appreciated increase in risk to the mother or fetus.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Abdomen Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopy Group

The laparoscopy group included every pregnant woman having laparoscopic intervention because of acute abdominal pain during any trimester of her pregnancy.

Laparoscopy vs Non-laparoscopy approach

Intervention Type PROCEDURE

Pregnant women who will undergo a laparoscopic or open surgical exploration of the abdomen

Non-laparoscopy Group

Non-laparoscopy Group included every pregnant woman having treatment approach other than the laparoscopic approach because of acute abdominal pain.

Laparoscopy vs Non-laparoscopy approach

Intervention Type PROCEDURE

Pregnant women who will undergo a laparoscopic or open surgical exploration of the abdomen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopy vs Non-laparoscopy approach

Pregnant women who will undergo a laparoscopic or open surgical exploration of the abdomen

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All pregnant women having acute abdomen and underwent surgical intervention will be included in this study.

Exclusion Criteria

* Non-pregnant women with acute abdomen are excluded.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emad Ali Ahmed Ali

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Augustin G, Majerovic M. Non-obstetrical acute abdomen during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2007 Mar;131(1):4-12. doi: 10.1016/j.ejogrb.2006.07.052. Epub 2006 Sep 18.

Reference Type BACKGROUND
PMID: 16982130 (View on PubMed)

Di Saverio S, Podda M, De Simone B, Ceresoli M, Augustin G, Gori A, Boermeester M, Sartelli M, Coccolini F, Tarasconi A, De' Angelis N, Weber DG, Tolonen M, Birindelli A, Biffl W, Moore EE, Kelly M, Soreide K, Kashuk J, Ten Broek R, Gomes CA, Sugrue M, Davies RJ, Damaskos D, Leppaniemi A, Kirkpatrick A, Peitzman AB, Fraga GP, Maier RV, Coimbra R, Chiarugi M, Sganga G, Pisanu A, De' Angelis GL, Tan E, Van Goor H, Pata F, Di Carlo I, Chiara O, Litvin A, Campanile FC, Sakakushev B, Tomadze G, Demetrashvili Z, Latifi R, Abu-Zidan F, Romeo O, Segovia-Lohse H, Baiocchi G, Costa D, Rizoli S, Balogh ZJ, Bendinelli C, Scalea T, Ivatury R, Velmahos G, Andersson R, Kluger Y, Ansaloni L, Catena F. Diagnosis and treatment of acute appendicitis: 2020 update of the WSES Jerusalem guidelines. World J Emerg Surg. 2020 Apr 15;15(1):27. doi: 10.1186/s13017-020-00306-3.

Reference Type BACKGROUND
PMID: 32295644 (View on PubMed)

Zachariah SK, Fenn M, Jacob K, Arthungal SA, Zachariah SA. Management of acute abdomen in pregnancy: current perspectives. Int J Womens Health. 2019 Feb 8;11:119-134. doi: 10.2147/IJWH.S151501. eCollection 2019.

Reference Type BACKGROUND
PMID: 30804686 (View on PubMed)

Jackson H, Granger S, Price R, Rollins M, Earle D, Richardson W, Fanelli R. Diagnosis and laparoscopic treatment of surgical diseases during pregnancy: an evidence-based review. Surg Endosc. 2008 Sep;22(9):1917-27. doi: 10.1007/s00464-008-9989-6. Epub 2008 Jun 14.

Reference Type BACKGROUND
PMID: 18553201 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

soh-med-42342

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Outcomes of Uterine Rupture
NCT02878226 COMPLETED