Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Primary endpoint: 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. Secondary endpoints: quality of life 6 months after surgery continence 6 months after surgery pain postoperative complication rate duration of procedure lengh of stay Hypothesis: 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. Inclusion criteria: - benign indication for left sided colectomy. exclusion criteria: 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.

Official Title
-----------------
Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Conditions
-----------------
Sigmoid Diverticulosis, Sigmoid Diverticulitis, Colon Adenoma, Rectal Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: benign indication for left sided colectomy Exclusion Criteria: age below 18 years unable to understand informed consent of missing informed consent emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transrectal hybrid-NOTES anterior resection<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transanal specimen extraction possible or not | 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. | at surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo) | 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. | up to 6 weeks postoperative | 
| continence 6 months postoperative |  | 6 months postoperative | 
| quality of life |  | 6 months postoperative |