Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03988348
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.9
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Disease	Procedure: infraumbilical transverse incision; Procedure: intraumbilical incision	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion in Gynecologic Laparoscopy: A Randomized Controlled Trial
• Actual Study Start Date: Aug 4, 2019
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group infraumbilical transverse incision will be done	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
Active Comparator: control group Direct intraumbilical transverse incision will be done	Procedure: intraumbilical incision; right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access

Outcome Measures

Primary Outcome Measures

1. the mean difference in the duration of surgery [30 minutes]

   calculated from the onset of surgery till the end

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03988348
• Other Study ID Numbers: IUL
• First Posted: Jun 17, 2019
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 25, 2020