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Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy

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ClinicalTrials.gov Identifier: NCT02879487
Recruitment Status : Unknown
Verified September 2016 by salih taskin, Ankara University.
Recruitment status was:  Recruiting
First Posted : August 25, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
salih taskin, Ankara University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Wound Dehiscence Device: Monopolar needle electrode Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: Coagulation mode
Colpotomy will be performed by monopolar needle electrode using coagulation mode
Device: Monopolar needle electrode
Colpotomy during total laparoscopic hysterectomy

Active Comparator: Cut mode
Colpotomy will be performed by monopolar needle electrode using cut mode
Device: Monopolar needle electrode
Colpotomy during total laparoscopic hysterectomy




Primary Outcome Measures :
  1. Vaginal dehiscence [ Time Frame: 3 months ]
    Vaginal dehiscence up to 3 months after surgery



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879487


Contacts
Contact: Salih Taşkın, MD +903125956405 staskin@yahoo.com

Locations
Turkey
Ankara University Medical Faculty Hospital Recruiting
Ankara, Turkey, 06100
Contact: Salih Taskin, MD    +3125957869    salihtaskin@yahoo.com   
Principal Investigator: Salih Taskin, MD         
Sub-Investigator: Yavuz Emre Şükür, MD         
Sub-Investigator: Batuhan Turgay, MD         
Principal Investigator: Fırat Ortaç, MD         
Sponsors and Collaborators
Ankara University
Investigators
Study Chair: Emre Şükür, MD Ankara University

Responsible Party: salih taskin, Assoc Prof, Ankara University
ClinicalTrials.gov Identifier: NCT02879487     History of Changes
Other Study ID Numbers: 01
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Surgical Wound
Surgical Wound Dehiscence
Wounds and Injuries
Postoperative Complications
Pathologic Processes