NCT03988348

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 4, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

June 13, 2019

Last Update Submit

March 23, 2020

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • the mean difference in the duration of surgery

    calculated from the onset of surgery till the end

    30 minutes

Study Arms (2)

study group

EXPERIMENTAL

infraumbilical transverse incision will be done

Procedure: infraumbilical transverse incision

control group

ACTIVE COMPARATOR

Direct intraumbilical transverse incision will be done

Procedure: intraumbilical incision

Interventions

infraumbilical transverse incisionPROCEDURE

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

study group
intraumbilical incisionPROCEDURE

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

control group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 17, 2019

Study Start

August 4, 2019

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

EG(1)