Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
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|ClinicalTrials.gov Identifier: NCT01992406|
Recruitment Status : Unknown
Verified July 2015 by Daniel Steinemann, MD, Cantonal Hosptal, Baselland.
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : July 17, 2015
|Condition or disease|
|Sigmoid Diverticulosis Sigmoid Diverticulitis Colon Adenoma Rectal Prolapse|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2016|
|Transrectal hybrid-NOTES anterior resection|
- Transanal specimen extraction possible or not [ Time Frame: at surgery ]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 ]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 ]
- quality of life [ Time Frame: 6 months postoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|