Proctocolectomy and ileal pouch anal anastomosis: total mesorectal excision versus Close Rectal excision
| ISRCTN | ISRCTN35140084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35140084 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/08/2007
- Registration date
- 23/08/2007
- Last edited
- 06/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr W.A. Bemelman
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| W.A.Bemelman@amc.uva.nl |
Study information
| Study design | Randomised, double-blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Proctocolectomy and ileal pouch anal anastomosis: total mesorectal excision versus Close Rectal excision |
| Study acronym | Close Rectal |
| Study objectives | Not much is known about the function of the pouch in relation to the space in which it is situated. At the time of construction the pouch will have a volume of +100 ml expanding over time towards its final volume + 300 ml. These data account for patients who had a proctectomy according to the Total Mesorectal Excision (TME) technique. The Close Rectal Excision (CRE) technique leaves the mesorectum in place in contrast to the TME. Theoretically, the pouch does have less space for distension. It is not known how the two techniques effect long-term pouch volume and whether this result in a difference in pouch function. The objective of this study is to evaluate the baseline volume and distensibility of the pouch, and pouch function in patients having had restorative proctocolectomy either applying a close rectal dissection or a total mesorectal excision technique to extirpate the rectum. |
| Ethics approval(s) | Ethics approval received from the Medical Ethics Committee AMC, Amsterdam on the 26th April 2006 (ref: MEC 06/061). |
| Health condition(s) or problem(s) studied | Ileal pouch anal anastomosis |
| Intervention | Close rectal dissection of the rectum. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Baseline volume and distensibility of the pouch, measured at least one year after surgery 2. Continence, measured through questionnaires at 1, 3, 6 and 12 months following surgery 3. Quality of life, measured through questionnaires at 1, 3, 6 and 12 months following surgery |
| Secondary outcome measures | 1. Morbidity 2. Blood loss |
| Overall study start date | 23/06/2006 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Indication for proctocolectomy with construction of ileoanal pouch 2. Ulcerative Colitis or Familial Adenomatous Polyposis 3. Informed consent |
| Key exclusion criteria | 1. Aged less than 18 years 2. American Society of Anaesthesiologists (ASA) III/IV 3. (Severe) postoperative complication 4. Emergency procedure |
| Date of first enrolment | 23/06/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Thesis results | 01/01/2014 | 06/08/2021 | No | No |
Editorial Notes
06/08/2021: Link to thesis added.
