Condition category
Signs and Symptoms
Date applied
26/05/2009
Date assigned
09/07/2009
Last edited
09/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beat Roth

ORCID ID

Contact details

Department of Urology
Inselspital
Bern
3010
Switzerland
+41 (0)31 632 2045
beat.roth@insel.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

51/09

Study information

Scientific title

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

Acronym

Study hypothesis

A delay of intestinal transit, prolonged post-operative pain, a delay in mobilisation and therefore increased post-operative complications such as pneumonia, deep venous thrombosis and pulmonary embolism are frequently seen after cystectomy and pelvic lymphadenectomy (PLND). This may be due to adhesions of small bowel and iliac vessels after PLND and cystectomy.

Our hypothesis is that closing the dorsal peritoneal layer over the iliac vessels bilaterally after cystectomy and PLND has a beneficial impact on gastrointestinal recovery, post-operative pain management and complications.

Ethics approval

Ethikkommission des Kantons Bern gave approval on the 25th May 2009

Study design

Randomised single blinded single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prolonged post-operative pain

Intervention

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 over the iliac vessels; performed with a running suture on each side

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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.

Overall trial start date

01/01/2009

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/01/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

Department of Urology
Bern
3010
Switzerland

Sponsor information

Organisation

Inselspital, University Hospital Berne (Switzerland)

Sponsor details

Department of Urology
Bern
3010
Switzerland
+41 (0)31 632 2045
urology@insel.ch

Sponsor type

Hospital/treatment centre

Website

http://www.insel.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

Inselspital, University Hospital Berne (Switzerland) - Department of Urology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes