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 |
| Secondary identifying numbers | 51/09 |
- 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
Scientific
Department of Urology
Inselspital
Bern
3010
Switzerland
| Phone | +41 (0)31 632 2045 |
|---|---|
| beat.roth@insel.ch |
Study information
| Study design | Randomised single blinded single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2009 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
3010
Switzerland
Sponsor information
Inselspital, University Hospital Berne (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Department of Urology
Bern
3010
Switzerland
| Phone | +41 (0)31 632 2045 |
|---|---|
| urology@insel.ch | |
| Website | http://www.insel.ch/ |
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
Hospital/treatment centre
Inselspital, University Hospital Berne (Switzerland) - Department of Urology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
