Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion

Gynecologic Disease Clinical Trial

Official title:

Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion in Gynecologic Laparoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03988348
• Other study ID #: IUL
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2019
• Est. completion date: March 2021

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. These scars may have negative impacts, such as psychological consequences. The symptoms associated with the wound, such as pain, tenderness, and itching, can be induced by the scars

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All women subjected to direct trocar application as a part of any gynecologic procedure performed

Exclusion Criteria:

• Verres needle insertion.

• Patients with previous abdominal surgery and scar,

• umbilical hernia,

• previous laparoscopy or previous umbilical surgery,

• burns in the umbilical region;

• who have hyperpigmented skins.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Procedure:
• infraumbilical transverse incision
a 10 mm infraumbilical transverse incision will be done to allow trocar to be inserted without undue resistance from the skin so that the trocar will pass through the fascia and the peritoneum with ease
• intraumbilical incision
right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the mean difference in the duration of surgery	calculated from the onset of surgery till the end	30 minutes