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Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions

Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05823935
Enrollment
40
Registered
2023-04-21
Start date
2022-11-05
Completion date
2023-11-30
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Diseases

Keywords

TLH, Bakay purse string

Brief summary

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

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.

Interventions

PROCEDUREBakay 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.

PROCEDURECuff 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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total operative timeFrom start to end of operationThe time between placement of the operative ports and successful closure of the vaginal cuff
Operative time for colpotomy and vaginal cuff closureFrom start colpotomy to end of vaginal cuff closureThe time between first anchor suture placement and successful closure of the vaginal cuff

Countries

Egypt

Contacts

Primary ContactAhmed M Elashry, MSc
elashry11090@gmail.com+201066556370
Backup ContactMohamed S Abdelhafez, MD
msabdelhafez@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026