Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03038945
• Date of registration: 19/01/2017
• Prospective Registration: No
• Primary sponsor: CES University
• Public title: Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
• Scientific title: Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
• Date of first enrolment: October 2016
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03038945
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Colombia

Contacts

• Name: CLAUDIA LOPEZ, Gynecologist
• Affiliation: CLINICA DEL PRADO

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients scheduled for total laparoscopic hysterectomy without other simultaneous
procedures , for benign causes , who were agree to participate in the trial and give
their written consent.

- Patients ASA (American Society of Anesthesiologists) 1 and 2

- Patients who are able to communicate by telephone and answer questions

Exclusion Criteria:

- Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic
obstructive pulmonary disease), collagen diseases, diabetes.

- Endometriosis III / IV

- Patients who can not be reached by phone



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Gynecologic Surgical Procedures

Intervention(s)

Other: 2/0 barbed suture

Other: 0/0 Vicryl suture

Primary Outcome(s)

Cuff closure time [Time Frame: 20 minutes]

Secondary Outcome(s)

Dyspareunia [Time Frame: 12 weeks]

Intra or postoperative complications [Time Frame: 10 days]

Secondary ID(s)

377

Source(s) of Monetary Support

Please refer to primary and secondary sponsors