Laparoscopic Value in the Management of Acute Abdomen During Pregnancy

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05407922
Collaborator
(none)
50
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopy vs Non-laparoscopy approach

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Laparoscopic Value in the Management of Acute Abdomen During Pregnancy
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

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

Outcome Measures

Primary Outcome Measures

  1. Early complications for the mother and fetus [through study completion, an average of 1 year]

    during the postoperative hospital stay

Secondary Outcome Measures

  1. Late complications for the mother and fetus [30 days]

    during the first 30 days postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Emad Ali Ahmed Ali, Lecturer, Sohag University
ClinicalTrials.gov Identifier:
NCT05407922
Other Study ID Numbers:
  • soh-med-42342
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2022