Systematic Approach for Cold Knife Morcellation of Large Uterus in Total Laparoscopic Hysterectomy

NCT ID: NCT07330102

Last Updated: 2026-01-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2025-12-29

Brief Summary

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Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.

Detailed Description

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Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.

Conditions

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Hysterectomy, Benign Uterine Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Morecellation group

Morcellation of the large uterus

Group Type EXPERIMENTAL

Morcellation

Intervention Type PROCEDURE

Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.

Interventions

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Morcellation

Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women candidates for total laparoscopic hysterectomy
* Uterus size \>/= 20 weeks gravid uterus
* Benign uterine disease

Exclusion Criteria

* • Malignant or premalignant uterine disease
* Bleeding disorders
* Unfit for surgery
* Contraindications for laparoscopy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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368

Identifier Type: -

Identifier Source: org_study_id

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