Laparoscopic Value in the Management of Acute Abdomen During Pregnancy

NCT05407922 | Unknown DMC

• 1 other identifier: soh-med-42342
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Abdomen; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Early complications for the mother and fetus

  during the postoperative hospital stay

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Late complications for the mother and fetus

  30 days

Study Arms (2)

Laparoscopy Group

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

Procedure: Laparoscopy vs Non-laparoscopy approach

Non-laparoscopy Group

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

Procedure: Laparoscopy vs Non-laparoscopy approach

Interventions

Laparoscopy vs Non-laparoscopy approach PROCEDURE

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

Laparoscopy Group; Non-laparoscopy Group

Eligibility Criteria

• Gender Eligibility Details: pregnant females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any pregnant woman presented with acute abdominal pain to the emergency department

You may qualify if:

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

You may not qualify if:

• Non-pregnant women with acute abdomen are excluded.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• 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.

  PMID: 16982130 BACKGROUND

• 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.

  PMID: 32295644 BACKGROUND

• 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.

  PMID: 30804686 BACKGROUND

• 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.

  PMID: 18553201 BACKGROUND

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06