Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy

Ankara University

Status: Completed

Conditions: Surgical Wound Dehiscence

Treatments: Device: Monopolar needle electrode

Study type: Interventional

Funder types: Other

Identifiers

NCT02879487

01

Details and patient eligibility

About

The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.

Enrollment: 200 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All total laparoscopic hysterectomies performed by a single surgeon
• Both benign and malignant cases
• Completed laparoscopically
• Intracorporeal vaginal cuff suturing

Exclusion criteria

• Robotic hysterectomies
• Pelvic infection within 30 days before surgery
• Conversion to laparotomy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Coagulation mode

Active Comparator group

Description:

Colpotomy will be performed by monopolar needle electrode using coagulation mode

Treatment:

Device: Monopolar needle electrode

Cut mode

Active Comparator group

Description:

Colpotomy will be performed by monopolar needle electrode using cut mode

Treatment:

Device: Monopolar needle electrode