Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion

NCT ID: NCT03988348

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-04

Study Completion Date

2021-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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study group

infraumbilical transverse incision will be done

Group Type EXPERIMENTAL

infraumbilical transverse incision

Intervention Type PROCEDURE

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

control group

Direct intraumbilical transverse incision will be done

Group Type ACTIVE_COMPARATOR

intraumbilical incision

Intervention Type PROCEDURE

right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access

Interventions

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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

Intervention Type PROCEDURE

intraumbilical incision

right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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ahmed abbas, MD

Role: primary

00201003385183

ahmed abbas

Role: backup

Other Identifiers

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IUL

Identifier Type: -

Identifier Source: org_study_id

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