Clinical trial NCT01992406: Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
Official title: Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sigmoid Diverticulosis
Sigmoid Diverticulitis
Colon Adenoma
Rectal Prolapse
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with benign indication for left sided colectomy

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.

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

Primary outcomes:
measure: Transanal specimen extraction possible or not
timeFrame: at surgery
Secondary outcomes:
measure: Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)
timeFrame: up to 6 weeks postoperative
measure: continence 6 months postoperative
timeFrame: 6 months postoperative
measure: quality of life
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland, Department of Surgery, Bruderholz
Study officials:
affiliation: Kantonsspital Baselland, Department of Surgery, Bruderholz
name: Andreas Zerz, MD
role: STUDY_CHAIR
References:
citation: Steinemann DC, Zerz A, Germann S, Lamm SH. Anorectal Function and Quality of Life after Transrectal Rigid-Hybrid Natural Orifice Translumenal Endoscopic Sigmoidectomy. J Am Coll Surg. 2016 Aug;223(2):299-307. doi: 10.1016/j.jamcollsurg.2016.04.002. Epub 2016 Apr 13.