Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
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ClinicalTrials.gov Identifier: NCT00484835 |
Recruitment Status
: Unknown
Verified June 2007 by Southern Health.
Recruitment status was: Not yet recruiting
First Posted
: June 11, 2007
Last Update Posted
: August 8, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Total Abdominal Hysterectomy | Procedure: Performing abdominal hysterectomy using gyrus electrocoagulation forceps | Phase 1 |
Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps & the other group with the traditional clamp & suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent.
The researcher will collect relevant data including age of patient, medical & surgical history and data relating to both the primary & secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay & cost.
A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.
Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal & cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy |
Study Start Date : | September 2007 |
Estimated Study Completion Date : | August 2008 |

- Operating time, Blood loss, Post-operative pain [ Time Frame: 1 year ]
- Length of hospital stay, Cost of the procedure [ Time Frame: 1 year ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Any patient already on waitlist in Southern Health for abdominal hysterectomy with suspected benign pathology
Exclusion Criteria:
- Patients without consent and/or with suspected malignant pathology

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): NCT00484835
Contact: Marziya Kadir, MBBS | 613 95946666 | marziya@hotmail.com | |
Contact: Jason Tan, MBBS, MRANZCG | 61409116446 | jasontan@iinet.net.au |
Australia, Victoria | |
Casey Hospital | Not yet recruiting |
Melbourne, Victoria, Australia | |
Dandenong Hospital | Not yet recruiting |
Melbourne, Victoria, Australia | |
Monash Medical Centre(Moorabin) | Not yet recruiting |
Melbourne, Victoria, Australia | |
Contact: Marziya Kadir, MBBS 613 95946666 marziya@hotmail.com | |
Contact: Jason Tan, MBBS, MRANZCG 61409116446 jasontan@iinet.net.au |
Principal Investigator: | Marziya Kadir, MBBS | Southern Health |
ClinicalTrials.gov Identifier: | NCT00484835 History of Changes |
Other Study ID Numbers: |
Electrocoag Forceps in TAH |
First Posted: | June 11, 2007 Key Record Dates |
Last Update Posted: | August 8, 2007 |
Last Verified: | June 2007 |
Keywords provided by Southern Health:
Abdominal Hysterectomy Electrocoagulation forceps |
Electrosurgery Gyrus plasma open seal forceps Patients undergoing abdominal hysterectomy for various reasons |