Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional 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|