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A comparative, single-blind, randomised trial of pain and ultrasound estimation of residual pelvic fluid associated with suction or non-suction drains following gynaecological laparoscopy

A comparative, single-blind, randomised trial of pain and ultrasound estimation of residual pelvic fluid associated with suction or non-suction drains following gynaecological laparoscopy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000109303
Enrollment
180
Registered
2008-02-27
Start date
2006-08-01
Completion date
Unknown
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

The aim of this trial is to estimate the difference in pain associated with the wearing or removal of suction or non-suction drains following gynaecological laparoscopic surgery.

Interventions

Participants who are determined to require post-operative drainage will be allocated to receive either a suction or non-suction #14FC Bellovac drain (AstraTech, Sweden). Drains are inserted at the end of the procedure through the left-lateral port site. The drain is removed by nursing staff following medical review by the surgical team. The duration the drain is left in situ is dependent upon medical review.

Sponsors

Department of Endo-Gynaecology
Lead SponsorOther Collaborative groups

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Women undergoing a laparoscopic procedure for resection of stage I-IV endometriosis, hysterectomy, myomectomy, salpingectomy, oophorectomy, cystectomy, urethropexy, adhesiolysis or any combination of these surgeries who would possibly require post-operative drainage were approached for inclusion in the study; female aged 18-80; fluent in spoken and written English, able to understand implications of their involvement in the study and those who consent to involvement in the study.

Exclusion criteria

Exclusion criteria include patients who may become distressed due to involvement in the study, intercurrent conditions precluding participation, known or suspected pregnancy and known or suspected gynecological malignancy. Women who have not been previously sexually active will be excluded from transvaginal ultrasound assessment

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 5, 2026