Laparoscopic Value in the Management of Acute Abdomen During Pregnancy

Pregnancy Related Clinical Trial

Official title:

Laparoscopic Value in the Management of Acute Abdomen During Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05407922
• Other study ID #: soh-med-42342
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: March 2023

Study information

• Verified date: June 2022
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen
• Pregnancy Related

Intervention

Procedure:
• Laparoscopy vs Non-laparoscopy approach
Pregnant women who will undergo a laparoscopic or open surgical exploration of the abdomen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & 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. Review. — View Citation

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, Leppäniemi 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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early complications for the mother and fetus	during the postoperative hospital stay	through study completion, an average of 1 year
Secondary	Late complications for the mother and fetus	during the first 30 days postoperatively	30 days