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?

ISRCTN	ISRCTN71612361
DOI	https://doi.org/10.1186/ISRCTN71612361
Protocol serial number	51/09
Sponsor	Inselspital, University Hospital Berne (Switzerland)
Funder	Inselspital, University Hospital Berne (Switzerland) - Department of Urology

Submission date: 26/05/2009
Registration date: 09/07/2009
Last edited: 09/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Beat Roth
Scientific

Department of Urology
Inselspital
Bern
3010
Switzerland

Phone	+41 (0)31 632 2045
Email	beat.roth@insel.ch

Study information

Primary study design	Interventional
Study design	Randomised single blinded single centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethikkommission des Kantons Bern gave approval on the 25th May 2009
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Switzerland

Study participating centre

Department of Urology

Bern
3010
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes