Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions

NCT ID: NCT05823935

Last Updated: 2023-04-21

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-05

Study Completion Date

2023-11-30

Brief Summary

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To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.

Detailed Description

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The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.

Conditions

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Uterine Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bakay purse string group

Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.

Group Type ACTIVE_COMPARATOR

Bakay purse string

Intervention Type PROCEDURE

After developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments.

Cuff closure via vaginal route group

Vaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.

Group Type ACTIVE_COMPARATOR

Cuff closure via vaginal route group

Intervention Type PROCEDURE

After the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer.

Interventions

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Bakay purse string

After developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments.

Intervention Type PROCEDURE

Cuff closure via vaginal route group

After the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Benign uterine lesions e.g fibroid, adenomyosis,…etc.
* Patient acceptance to undergo laparoscopic hysterectomy.

Exclusion Criteria

* Gynecological malignancy.
* Low corporeal myoma obsecuring cervicovaginal junction.
* History of extensive abdominal surgery other than cesarean section.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed M Elashry, MSc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Hamed M Youssef, MD

Role: STUDY_CHAIR

Mansoura University

Maged R Elshamy, MD

Role: STUDY_DIRECTOR

Mansoura University

Mahmoud M Awad, MD

Role: STUDY_DIRECTOR

Mansoura University

Mohamed S Abdelhafez, MD

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M Elashry, MSc

Role: CONTACT

+201066556370

Mohamed S Abdelhafez, MD

Role: CONTACT

Other Identifiers

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MD.22.10.703

Identifier Type: -

Identifier Source: org_study_id

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