Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||6 Months|
|Official Title:||Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection|
- Transanal specimen extraction possible or not [ Time Frame: at surgery ] [ Designated as safety issue: No ]Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.
- Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo) [ Time Frame: up to 6 weeks postoperative ] [ Designated as safety issue: Yes ]Postoperative complications are recorded and graded according to Clavien-Dindo classification. Complication rates and especially occurence of anastomotic leakage and pelvic sepsis will be compared to the literature of current techniques.
- continence 6 months postoperative [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
|Transrectal hybrid-NOTES anterior resection|
To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.
- quality of life 6 months after surgery
- continence 6 months after surgery
- pain postoperative
- complication rate
- duration of procedure
- lengh of stay
The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).
study design: This is an open cohort study on 60 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.
- benign indication for left sided colectomy.
- age <18 years
- patient unable to understand informed consent or missing informed consent
- emergency surgery
power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01992406
|Contact: Daniel C Steinemann, MD||+41 61 436 36 email@example.com|
|Contact: Sebastian Lamm, MD||+41 61 436 36 firstname.lastname@example.org|
|Kantonsspital Baselland, Department of Surgery, Bruderholz||Recruiting|
|Bruderholz, Switzerland, 4101|
|Contact: Daniel C Steinemann, MD|
|Contact: Sebastian Lamm, MD|
|Principal Investigator: Daniel C Steinemann, MD|
|Principal Investigator: Sebastian Lamm, MD|
|Principal Investigator: Andreas Zerz, MD|
|Study Chair:||Andreas Zerz, MD||Kantonsspital Baselland, Department of Surgery, Bruderholz|