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?

Completed

• Conditions: Prolonged post-operative pain; Signs and Symptoms; Pain

• Registration Number: ISRCTN71612361
• Lead Sponsor: Inselspital, University Hospital Berne (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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