Does the closure of the dorsal peritoneal layer after cystectomy and extended pelvic lymphadenectomy have a significant beneficial impact on early post-operative recovery and complications?

Closure of the dorsal peritoneal layer after pelvic lymphadenectomy (PLND) and its impact on early post-operative recovery and complications: a randomised, single blinded, single centre study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71612361

Enrollment

200

Registered

2009-07-09

Start date

2009-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Prolonged post-operative pain Signs and Symptoms Pain

Interventions

Patients will be randomised to one of two groups: 1. Without closure of the dorsal peritoneal layer after PLND (as performed traditionally) 2. With closure of the dorsal peritoneal layer bilaterally o

performed with a running suture on each side

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A consecutive series of 200 patients scheduled for cystectomy and PLND for malignancy of the urinary bladder 2. Aged greater than 18 years, either sex

Exclusion criteria

Exclusion criteria: 1. Aged less than 18 years 2. Pregnancy 3. No informed consent available 4. Previous surgery of the pelvis with lymphadenectomy 5. Previous radiotherapy to the pelvis 6. Previous chemotherapy due to malignancy of pelvic organs

Design outcomes

Primary

Measure	Time frame
Complications (according to the Dondo/Clavien Classification System), measured post-operatively on days 1, 3, 7, 10, 14, and at 3, 6, 12 and 24 months.	—

Secondary

Measure	Time frame
1. Pain: according to the VAS (Visual Analogue Scale) 2. Bowel function/intestinal recovery: passage of stool, flatulence, nausea, vomiting Measured post-operatively on days 1, 3, 7, 10, 14, and at 3, 6, 12 and 24 months.	—

Countries

Switzerland

Outcome results

None listed

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