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Implication of Umbilical Port and Endoscope Size on Total Laparoscopic Hysterectomy

A randomised control trial comparing the effects of a 5 millimetre umbilical incision and endoscope with a 10 millimetre umbilical incision and endoscope in women undergoing a total laparoscopic hysterectomy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000696796
Enrollment
64
Registered
2013-06-25
Start date
2013-07-01
Completion date
2014-02-28
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Laparoscopy is increasingly replacing open surgery as the preferred treatment option in most patients across disciplines. Additionally as technological improvements have occurred, mini-laparoscopic instruments have been designed to further reduce surgical trauma and minimize invasiveness. There are several studies in the literature, which show that using mini-laparoscopic instruments does not increase complication rates and may reduce patient recovery. Typically a 10mm umbilical incision and endoscope is routine for a total laparoscopic hysterectomy. In 2011, St John of God Hospital began to use high definition 5mm endoscopes. At this stage Dr Salfinger began to complete his total laparoscopic hysterectomy with a 5mm umbilical incision and endoscope and anecdotally noted that patients were requesting discharge earlier. In 2012 Dr Salfinger and Acton audited 328 consecutive cases in a single-surgeon series of total laparoscopic hysterectomy, comparing use of 5mm and 10mm rigid laparoscopes examining for length of hospital stay (LOS), return to normal daily routine, complication rates and conversion to laparotomy in women aged between 29-92 years. Findings were a significant increase in the number of women being discharged from hospital on day 1 in the 5mm-scope group compared to the 10mm scope group. Both groups had similar blood loss and complication rates. Notably the 5mm-scope group also had a significantly shorter time to return to normal function (subjective, patient assessed outcome) with 8 days in comparison to 17 days for the 10mm scope group. Because of these findings we are encouraged to perform a randomized controlled trial examining the impact of umbilical incision, port size and endoscope size on total laparoscopic hysterectomy. This will be a randomized controlled trial with participants randomized to either the 10mm or 5mm incision and endoscope. Participants will be recruited from Dr Salfinger and Dr Tan’s patients. Data collected will include basic patient demographics, type of umbilical incision and endoscope used, operating time, complication rates, discharge time and post operative pain scores on day 1 and day 7. It is hoped that this data will be used by other surgeons and encourage them to trial 5mm umbilical incision and endoscope as well as other health centers, encouraging them to provide new technology for their surgeons and patients, aiming for shorter length of stay.

Interventions

5mm incision and endoscope used during laparoscopic hysterectomy made at umbilicus. The intervention is during the laparoscopic hysterectomy and the followup will be until their six week post-operative check.

Sponsors

Department of Gynaecologic Oncology, St John of God Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Requires laparoscopic hysterectomy for 1) early stage endometrial cancer, 2) Dysfunctional uterine bleeding, 3) competion surgery for other early stage cancer, 4)

Exclusion criteria

Laparoscopic hysterectomy for extensive endometriosis, planed ICU admission, procedure requiring omentectomy/nodes

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026