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Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial

Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00484835
Enrollment
60
Registered
2007-06-11
Start date
2007-09-30
Completion date
2008-08-31
Last updated
2007-08-08

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

Conditions

Total Abdominal Hysterectomy

Keywords

Abdominal, Hysterectomy, Electrocoagulation forceps, Electrosurgery, Gyrus plasma open seal forceps, Patients undergoing abdominal hysterectomy for various reasons

Brief summary

The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp & suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.

Detailed description

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.

Interventions

PROCEDUREPerforming abdominal hysterectomy using gyrus electrocoagulation forceps

Sponsors

Gyrus ACMI
CollaboratorINDUSTRY
Southern Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
Operating time, Blood loss, Post-operative pain1 year

Secondary

MeasureTime frame
Length of hospital stay, Cost of the procedure1 year

Countries

Australia

Contacts

Primary ContactMarziya Kadir, MBBS
marziya@hotmail.com613 95946666
Backup ContactJason Tan, MBBS, MRANZCG
jasontan@iinet.net.au61409116446

Outcome results

None listed

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