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Urological and sexual function in males following robotic vs laparoscopic rectal surgery

Urological and sexual function in males following robotic vs laparoscopic rectal surgery: An international, multicentre, randomised control trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14574075
Enrollment
70
Registered
2017-01-30
Start date
2017-03-01
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Specialty: Surgery, Primary sub-specialty: General Surgery

Interventions

Following provision of informed consent, participants are randomised to one of two groups. Stratified randomisation will take place through the use of previously filled opaque concealed envelopes. St

Sponsors

Poole Hospital NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of rectal cancer (=15 cm from anal verge on MRI staging) amenable to curative surgery OR patients with ulcerative colitis having proctectomy and ileo-anal pouch 2. Male 3. Aged 18 years and over 4. Able to provide written informed consent 5. Fit enough to undergo minimally invasive surgery (ASA=3) 6. Deemed suitable for minimally invasive surgery by local MDT 7. Elective case 8. Sexually active (this includes caressing, foreplay, masturbation and vaginal intercourse)

Exclusion criteria

Exclusion criteria: 1. Sexually inactive 2. Advanced tumours involving adjacent organs 3. Surgery performed with palliative intent 4. Unplanned/ emergency surgery

Design outcomes

Primary

MeasureTime frame
1. Urological function is measured using the International Prostatic Symptoms Score (IPSS) pre-operatively and 3, 6 and 12 months after surgery 2. Sexual function is measured using the International Index of Erectile Function (IIEF) pre-operatively and 3, 6 and 12 months after surgery 3. Urodynamics (urine flow rate and post micturition residual urine volume) are assessed by a uroflow meter and a bladder scanner pre-operatively and 3, 6 and 12 months after surgery

Secondary

MeasureTime frame
No secondary outcome measures

Countries

England, Portugal, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026