This study, comparing two cohorts, is designed to determine the postoperative residual mesorectum on MRI after TME. Patients with a clinical T1-3 rectal carcinoma (10cm or less from the anal verge based on preoperative MRI of the pelvis) who…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The objective of the study is to compare the amount of residual mesorectum
after laparoscopic and transanal TME in patients who should have had a complete
TME based on the height of the tumor. Primary endpoint is to determine the
prevalence and localization of residual mesorectum on magnetic resonance
imaging (MRI).
Secondary outcome
Not applicable.
Background summary
Worldwide, colorectal cancer is the third most common malignancy in males and
second most common malignancy in females. Approximately 33% of this tumors is
localized in the rectum. The standard potential curative treatment for rectal
cancer is surgery. In 1978, Heald accomplished a new approach calling the total
mesorectal excision (TME) at that time performed by extensive laparotomy. Over
the years surgery has evolved and nowadays laparoscopic TME is the golden
standard for rectal cancer surgery. Although short term benefits after
laparoscopic surgery have been shown, oncological quality and survival rates
don*t seem to improve. TME surgery can thereby still be improved and challenges
during rectal dissection remain.
Rectal surgery is considered difficult because of poor visualization of the
distal part of the rectum, especially in male and obese patients. By performing
a transanal TME (TaTME) the rectum is approached transanally and these
disadvantages are of lesser influence. The rectum is herewith mobilized under
direct endoscopic visualization beginning at the most distal margin of the
mesorectum, working upwards. Although no randomized trials have been published,
described advantages of TaTME are better visualization of the distal part of
the rectum, complete mesorectal excision and improved specimen.
Because of this advantages, we hypothesize that after TaTME, less residual
mesorectum will be found on postoperative MRI comparing to laparoscopic
approach, which could imply a decreased risk of recurrence.
Study objective
This study, comparing two cohorts, is designed to determine the postoperative
residual mesorectum on MRI after TME. Patients with a clinical T1-3 rectal
carcinoma (10cm or less from the anal verge based on preoperative MRI of the
pelvis) who underwent TaTME with curative intent are included. A corresponding
group of patients who underwent laparoscopic TME in The Gelderse Vallei
Hospital will be compared in terms of localization and amount of residual
mesorectum.
Study design
This study, comparing two cohorts, is designed to determine the postoperative
residual mesorectum on MRI after TME. Patients with a clinical T1-3 rectal
carcinoma (10cm or less from the anal verge based on preoperative MRI of the
pelvis) for whom a laparoscopic or transanal TME with curative intent was
performed. Patients who were operated in 2011 till 2013 in The Gelderse Vallei
Hospital were operated through laparoscopic approach. Patients in 2013 to 2015
underwent transanal TME, and will be included starting with the most recent and
working backwards until the amount of patients calculated are included.
Study burden and risks
Patients who underwent a laparoscopic TME will get magnetic resonance imaging
to determine postoperative residual mesorectum. Patients who underwent a
transanal TME already got a postoperative MRI according to protocol.
No significant biological effects are associated with conventional MR imaging.
Therefore, the estimated risk for study objects is classified as *negligible
risk* (Dutch: verwaarloosbaar risico).
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Clinical T1-3 rectal carcinoma
Tumor height wich a maximum of 10cm from the anal verge on preoperative MRI
Surgery performed with curative intent
Exclusion criteria
Previously diagnosed local recurrence
No preoperative MRI
Tumor height > 10cm from anal verge
Contraindication to MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL54533.029.15 |